Careers

Available Positions

In our Corporate Headquarters in Northern New Jersey, we foster a challenging and rewarding work environment for our employees. We are committed to attracting, developing and maintaining a diverse team of motivated, talented individuals where each person has the opportunity to realize his or her full potential.

QA Associate, Raw Material Release and Clinical Shipments

We are seeking a Quality Assurance Associate to be responsible for all QA-related aspects of material handling, storage, shipping and control, and associated documentation. This position may also be cross-trained on product disposition and regulated document/training functions.

Primary Responsibilities:

  • Quarantine materials, inspect shipments, examine Certificates of Analysis (COAs), review test results, determine release status, and manage all raw materials documentation
  • Coordination of clinical shipments
  • Preparation and circulation of controlled documents (e.g., specifications, labels)
  • Inventory management
  • Stability data review
  • Generation of associated reports
  • Conduct changeovers in production area as required
  • Participate in audits, investigations, corrective action/preventive action (CAPA), standard operating procedure (SOP) preparation/revision/review, and other projects as appropriate
  • Participate in issue resolution and identify opportunities for process/system improvement

Qualifications:

  • Bachelor’s degree in biology, chemistry, or related field, with 1-3 years prior GxP experience in a Biotechnological, Pharmaceutical, or Clinical environment; or equivalent combination of education and experience
  • Background/familiarity in raw material release and clinical shipments functions strongly preferred
  • Excellent written and verbal communication skills required; scientific writing experience a plus
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a fast-paced, timeline-driven environment necessary
  • Must be proficient with MS Office applications
  • Ideal candidate will possess a strong customer service philosophy

Starting salary range from 40k-50k, commensurate with experience, plus a comprehensive benefit package.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Senior Pharmaceutical Manufacturing Technologist

We are seeking a Senior Pharmaceutical Manufacturing Technologist to be responsible for the manufacturing of clinical products in compliance with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs).

Primary Responsibilities:

  • Operate ÄKTA protein purification system for large scale purification of monoclonal antibodies using ion-exchange and affinity column chromatography
  • Perform virus removal filtration
  • Prepare buffers (up to 200 L each)
  • Perform integrity tests (filter/membrane)
  • Maintain inventory of raw materials and supplies needed in manufacturing
  • Daily maintenance and calibration of all equipment needed during production
  • Monitor and assure adequate supply of glassware/components for manufacturing
  • Maintain accurate batch records, log books, and log sheets
  • Write/revise batch records, buffer sheets, SOPs, and Material Safety Sheets (MSSs)

Qualifications:

  • Bachelor’s degree in biology, chemistry, or related discipline, plus a minimum of 5 years of industry experience in protein purification, or equivalent combination of education and experience.
  • Proficiency with UNICORN software is required
  • Ability to follow SOPs and cGMP guidelines and regulations
  • Must possess excellent communication (oral and written) and interpersonal skills
  • Detail oriented with strong organizational, follow-through, and problem-solving skills
  • Must be able to work collaboratively in a team environment
  • Must be proficient with MS Office applications

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Pharmaceutical Sanitization Technician

We are seeking a Pharmaceutical Sanitization Technician to be responsible for the cleaning, disinfecting, and maintenance of all clean rooms and equipment in cGMP manufacturing areas.

Primary Responsibilities:

  • Cleans, sanitizes, and decontaminates the manufacturing and cell culture areas and equipment according to cGMP guidelines, SOPs, and any other pertinent policies and controls.
  • Maintains inventory of clean room garments for gowning.
  • Requests all necessary components and operating materials in order to ensure daily operations.
  • Maintains good communication with support departments in order to comply with all manufacturing needs.
  • Completes all required production documentation in a legible, error free, and timely manner following good documentation practices.
  • Attends all mandatory cGMP training meetings.
  • Ensures a safe work environment is maintained at all times. Brings equipment and facility issues to the attention of supervisor for resolution.
  • Writes work orders when necessary.
  • Cross trains as back-up for component preparation employees.

Qualifications:

  • High School diploma or General Education Degree (GED), with 1-3 years of aseptic experience in cGMP industry; or equivalent combination of education and experience.
  • Must be organized and possess basic math skills with the strong abilities to troubleshoot and problem-solve.
  • Must be able to easily understand and follow complex documented procedures, such as SOPs, and work in a clean room environment according to cGMP procedures.
  • Must be self-motivated and able to work with minimal supervision both independently and in a team setting.
  • Must be able to exert 50-100 pounds of force occasionally and/or in excess of 20 pounds of force regularly to move and lift heavy objects.
  • Must possess good oral and written communication skills and proficiency with MS Office.
  • Proven ability to succeed in a fast-paced, deadline-driven environment, with the availability to work overtime hours when needed.

Physical Requirements:

  • Must undergo a company-paid post offer/pre-employment physical examination (health surveillance clearance with general eye exam to confirm ability to read a minimum of font size 10 with or without correction) and receive clearance to work from the attending physician prior to starting employment. This physical examination will be an annual requirement thereafter.
  • Must also be able to: be medically cleared and be “fit tested” (with a clean shaven face) to wear a respirator; maneuver/transport compressed gasses.

Starting annual salary range of $40,000-$45,000, commensurate with experience, plus a comprehensive benefit program. Please provide salary history and/or expectations at the time of application.

Resumes without salary information will not be considered.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Local candidates preferred. No relocation assistance for this opportunity.

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Associate Director/Director, Patient Advocacy

Immunomedics, Inc., a biotechnology company located in Morris County, NJ, is seeking an Associate Director/Director, Patient Advocacy to develop, implement, and lead our patient advocacy function.

Primary Responsibilities:

  • Engage and establish partnerships with key patient-centric advocacy stakeholders and professional organizations in relevant geographical areas. Serve as primary point of contact to foster strong, compliant, productive, and value-added alliances with these groups.
  • Acquire feedback and perspective from patients, families, medical professionals, policy makers, and others within the patient support community. Gained insight will be applied to business decisions related to addressing patient needs and providing impactful solutions and services that will support them. Champion the patient perspective to aid with enhancing their experience.
  • Determine opportunities and needs for advocacy engagement. Create strategic and operational patient advocacy plans in collaboration with internal cross-functional teams and applicable thought leaders.
  • Based on a clear understanding of and empathy for the patient experience, design and create processes, systems, solutions, and tools that will contribute to the effectiveness and success of the patient advocacy plans.
  • Determine compelling ways of increasing awareness about clinical studies (both company and investigator-sponsored) through patient advocacy organizations and other internal and external partnerships
  • Create a message that reflects Immunomedics’ commitment to patients, their caregivers, and advocacy groups. Collaboratively develop an effective communication plan.
  • Ensure programs are aligned to meet strategic goals and the needs of our patients while being compliant with local, regional, national, and global regulatory guidelines as applicable.

Qualifications:

  • BA/BS in a relevant scientific or clinical discipline with at least 7-10 years of progressive work experience in a biotech, pharmaceutical, or clinical research setting with direct responsibility for patient advocacy engagement. Advance degree preferred.
  • Strong desire to improve the lives of patients, their caregivers, and families. Possess compassion and empathy coupled with a high degree of integrity and accountability.
  • Demonstrated leadership and collaboration skills with a proven ability to build and maintain relationships with diverse groups of people and audiences.
  • Prior experience either working with or working for patient advocacy organizations and related groups. Must have a broad network of established relationships with oncology advocacy groups, specifically those that support breast cancer patients.
  • Excellent verbal, written, and presentation communication skills. Adept at creating and communicating a clear vision and purpose to internal and external (existing and prospective) stakeholders, effectively aligning resources and motivating the “team” to achieve goals and create partnership-style relationships.
  • Should have experience with clinical, medical, and commercial teams with ability to influence business and corporate strategy from a patient and human perspective
  • Must be proficient in areas of relationship and network management, event planning, industry standards and regulations, coupled with a strong awareness of emerging trends around patient-centered research and technology, patient experience, and patient-reported outcomes.
  • Expertise with online and offline strategies, tools, and techniques for research, engagement, collaboration, and feedback.
  • Able to summarize complex medical and scientific concepts using layman’s terms to successfully communicate to target patient/advocate audience.
  • Solid understanding of the applicable regulatory environment and industry standards.
  • Demonstrated technical, organizational, project management, and negotiation capabilities. Must be a self-starter with excellent ability to implement and execute.
  • Prior experience in oncology and autoimmune diseases.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Senior Director, Clinical Operations

We are seeking a Senior Director, Clinical Operations to oversee the successful planning and execution of clinical development and study management plans based on demonstrated clinical expertise, extensive leadership, and operational experience. This individual will provide operational and strategic leadership within the clinical research organization and be responsible for consistent and successful execution of operational aspects of clinical trial studies, with a focus on quality, cost, and timeliness.

Primary Responsibilities:

  • Will be accountable for the direction, implementation, execution, and monitoring of all clinical studies, including protocol development and review, investigator and clinical site selection, and CRO/vendor selection and management to ensure the successful filings and approval of INDs and NDAs.
  • Provide expert advice to senior management for the evaluation of all clinical operations and ongoing interpretation of project findings. Deliver study progress updates to corporate leadership.
  • Develop study management plans that include enrollment milestones, risk mitigation, financial oversight, communication requirements, monitoring plans, and study progress according to established timelines and goals.
  • Contribute to the writing and review of clinical documents such as NDA, BLA, and IND submissions, protocols, informed consents, investigator brochures, monitoring plans, and clinical study reports.
  • Collaborate and partner with other functional area experts for feedback on study protocols, development plans, publications, etc.
  • Ensure quality of clinical plans, project specifications, study protocols, reports, and other relevant deliverables. Assist with establishing and approving scientific methods used for the design and implementation of data collection systems, and associated activities.
  • Manage, train, develop, and lead cross-functional teams (e.g., clinical team, study management team, data management team, etc.).
  • Analyze company goals in relation to new and ongoing projects to ensure appropriate balance between new and ongoing programs, inclusive of budget and resource management.
  • Provide overall administrative and technical direction in support of all emerging clinical projects and collaborate with senior management in assessing requirements.
  • Seek continuous improvement of the quality of group’s deliverables and effective use of applicable technologies within the group and the Company.

Qualifications:

  • BA/BS in a scientific or clinical discipline with at least 15 years of progressive work experience in clinical operations, managing clinical programs and personnel in a biotech or pharmaceutical environment. Advance degree preferred.
  • Knowledge and demonstrated proficiency in all areas of clinical operations, including the implementation, monitoring, and management of clinical trials, development process, methods of scientific investigation, data management (e.g., database lock and data analysis), and US and global regulatory requirements and guidelines.
  • Practical and extensive experience in clinical trial strategies, methods, and processes; deep knowledge of clinical trial implementation and management. Participation in large multi-center and/or global trials, investigational site and CRO management, data collection study protocol compliance, and accountability for budget/timelines.
  • Demonstrated track record of translating senior level clinical research/scientific business requirements into operational strategies.
  • Solid understanding of US and global regulations and guidelines (e.g., FDA, EMA, ICH) applicable to clinical development; prior success in partnering with regulatory peer to support timely and quality regulatory submissions.
  • Excellent verbal, written, analytical, and presentation communication skills. Adept at creating and communicating a clear vision among direct reports and cross-functional teams, effectively aligning resources and motivating teams to achieve goals. Must also be able to effectively communicate with colleagues and associates outside the organization to create partnership-style relationships.
  • Demonstrated technical, organizational, project management, and negotiation capabilities.
  • Strong experience in oncology and autoimmune diseases.
  • Experience with Phase I – IV clinical trials.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Director, Clinical Safety

We are seeking a Director, Clinical Safety to be responsible for management and oversight of the clinical drug safety function associated with Company-sponsored and Investigator-sponsored clinical trials. Will perform safety assessments and surveillance; reporting to regulatory authorities that is compliant, thorough, and timely; identification and mitigation of risk; and communication of safety information while continuing to build the clinical safety and pharmacovigilance function.

Primary Responsibilities:

  • Primary contact for clinical safety-related activities for both Immunomedics-sponsored trials and Investigator-sponsored trials.
  • Oversee the achievement of accurate, complete, and timely regulatory reporting for Clinical safety-related items. Evaluate current processes and assess alignment with regulatory expectations, guidelines, and mandates. Develop procedural documentation, standard operating procedures, and guidelines. Evaluate process optimization opportunities.
  • Lead the review and interpretation of serious adverse events (SAEs) in accordance with the Code of Federal Regulations, European guidelines, and Company requirements.
  • Ensure clinical safety database is properly maintained for quality control and information is made available to study management colleagues.
  • Based on SAE information in the database, generate case narratives derived from SAEs and case report forms (CRFs), and complete reports for SAEs. Draft Pharmacovigilance comments.
  • Prepare, track, and follow-up with expedited safety reports to regulatory agencies and/or partners.
  • Support the management of case processing deadlines for aggregate safety reporting.
  • Coordinate MedDRA coding and reconciliation processes.
  • Work with the Medical Director to define and initiate follow-up through the appropriate channels (direct interactions with the monitor or site as necessary).
  • Write queries and follow-up for resolution as needed. Track cases to completion.
  • Maintain filing system integrity for hardcopy reports.
  • Assist with reconciliation of non-serious adverse events in clinical and safety databases.
  • Chair Immunomedics’ quarterly safety meetings; track and distribute meeting minutes
  • Establish and maintain good working relationships with associated groups, especially Regulatory, Data Management, CROs, and development partners.
  • Participate in third-party visits (e.g., audits and inspections) as required.
  • Furnish information needed for Clinical Research in preparation of clinical documents and presentations and to Regulatory Affairs in preparation of regulatory documents.

Qualifications:

  • Advanced degree in medicine, nursing, pharmacy, public health, or other relevant field (e.g., MD, PhD, PharmD, MSN, or MPH) is required
  • At least 10 years of experience in clinical safety and pharmacovigilance in the biotechnology or pharmaceutical industry.
  • Must have experience in overseeing a full range of integrated risk management and assessment activities, including leading safety engagement in protocol development, investigator brochure development, final clinical study reports, and summaries of safety as well as expertise in clinical safety assessments, analysis, and interpretation of scientific and technical literature.
  • Prior safety experience with Phase I – IV clinical trials.
  • Clinical knowledge of therapeutic area (oncology required), patient populations, drug classes, and standards of care. Advanced ability to read, analyze, and interpret clinical data and information.
  • Strong knowledge of medical terminology and disease pathology for review of safety information and preparation of communication to Investigators.
  • Advanced industry knowledge of clinical safety including ICH, FDA, EMA, GCP regulations and guidelines concerning safety reporting.
  • Working knowledge of MedDRA and Pharmacovigilance-related databases (e.g., ARGUS or Aris-g).
  • Must be experienced in safety reviews of IBs, protocols, interim and final clinical study reports, and summaries of safety for both products in development and marketed products.
  • Excellent verbal and written communication skills.
  • Detail oriented with strong organizational, follow-through, and problem-solving skills.
  • Ability to lead, mentor, and work effectively with others as well as be able to work independently.
  • Ability to assess priorities and consistently meet regulatory and internal deadlines.
  • Strong interpersonal-communication and stakeholder-relationship skills.
  • A high degree of professionalism and the ability to maintain confidentiality.
  • Competency in MS Excel and Word.

Salary will be commensurate with experience, plus a comprehensive benefit program

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Senior Biostatistician

We are seeking a Senior Biostatistician to provide statistical expertise and technical support as it relates to the design and statistical analysis of clinical oncology and autoimmune disease studies. Develop and perform analysis and interpretation of study results.

Primary Responsibilities:

  • Provide timely and scientifically sound statistical guidance and technical expertise to clinical development projects.
  • Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
  • Work closely with data management and clinical research/clinical operations personnel to develop and validate study-specific data capture activities.
  • Develop statistical analysis plans to meet regulatory standards, coordinate and perform data analysis and validation, and provide data interpretation
  • Produce tables, figures, and listings for reporting of study results and data.
  • Assist in the development of study protocols, provide sample size estimates and calculations for study designs, and oversee generation of randomization schedule for complex randomization schemes.
  • Review study protocols, CRFs, data validation specifications, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data.
  • Write specifications for datasets, tables, figures, listings, and consistency checks for both efficacy and safety analyses; perform validation of key statistical results.
  • Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output.
  • Perform statistical analysis for publication.
  • Provide input in preparation of study reports, with particular emphasis on the statistical methods section, and work closely on study report preparation.
  • Collaborate with other key personnel in regard to the publication of study data.
  • Interact with FDA statisticians and other external parties as required.
  • Guide and collaborate with CRO staff to ensure alignment with established data, analysis, and quality standards.
  • Stay current with new developments in statistics, drug development, and regulatory guidance.
  • May supervise or lead other statistical or programming personnel as assigned.

Qualifications:

  • PhD degree in biostatistics, statistics, mathematics, or related discipline with 5+ years’ work experience in statistical analysis of clinical trials data OR a MS degree in biostatistics, statistics, mathematics, or related discipline with 7+ years’ work experience in statistical analysis of clinical trials data
  • Proficiency in SAS statistical programming. Must possess strong working knowledge of Microsoft SQL programming and SAS software system including, SAS/BASE, SAS/STAT, SAS/SQL, SAS/ODBC, SAS/ACCESS and SAS/GRAPH. Knowledge of other statistical and data management software/packages a plus.
  • Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; oncology and autoimmune disease experience is highly preferred.
  • Experience supporting publication of analysis results (e.g., abstracts, posters, manuscripts).
  • Extensive knowledge of industry standards, such as GCP and ICH guidelines, CDISC standards and models, 21 CFR Part 11, and FDA guidelines.
  • Familiarity with pharmacokinetic (PK) / pharmacodynamics (PD) data a plus.
  • Experience interacting (directly or indirectly) with the FDA.
  • Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
  • Effective interpersonal skills and problem solving capabilities. Strong project management and mentoring/leadership skills.
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Director, Manufacturing Supply Chain

We are seeking a Director, Manufacturing Supply Chain to lead the materials management and manufacturing supply chain activities, that includes procurement of and inventory management for all raw materials and components to support production planning, the manufacturing schedule, and distribution of materials and products.

Primary Responsibilities:

  • Provide materials management and supply chain leadership to support initial build, scale-up, and product manufacturing operations, both internally and with contract manufacturing organizations (CMOs).
  • Support internal and CMO manufacturing departments with raw materials to enable successful manufacturing according to established production schedule(s).
  • Develop a comprehensive supply chain strategy for all critical raw materials. Manage the supply of critical materials through inventory management.
  • Establish supply agreements with key vendors as required to mitigate manufacturing risks.
  • Direct teams in establishing and maintaining strategic business relationships with key vendors that meet corporate objectives, quality, regulatory requirements, and financial responsibility.
  • Develop and manage processes that ensure vendors are providing contracted services accurately, timely, efficiently, and in compliance with corporate policies, SOPs, cGMP, and other applicable regulations.
  • Ensure adequate supply of starting and in-process materials to avoid manufacturing delays and potential ‘out of stock’ issues.
  • Work closely with internal teams (e.g., Manufacturing, Quality, and Clinical) to establish and implement procedures for strategic planning to identify study drug requirements, ensure adequate supplies of targeted products are available for patients, and import/export requirements.
  • Integrate all programs and projects in a compliant manner by working closely with the Quality Unit and Regulatory Affairs.
  • Create and maintain supply chain and logistics metrics to enable process improvements.
  • Act as a key resource to interface between functions pertaining to supply, transportation, storage, logistics, and traceability issues.
  • Develop effective logistics to address redundancy, product expiration, temperature requirements, and monitoring.
  • Identify, recommend, and implement programs and/or systems to improve overall quality and that many recognize cost savings for the Company.

Qualifications:

  • Bachelor’s degree in life sciences, logistics/supply chain, or related discipline, with 10-12 years of directly related logistics, supply chain, and vendor management experience in cGMP industry for clinical or commercial production; prior managerial experience required.
  • Strong background in cGXP and ICH requirements and understanding of global regulatory requirements.
  • Demonstrated technical skills and background in logistics and supply chain management, including vendor/relationship management and process optimization.
  • Must have strong knowledge of domestic and international ground and air hazardous material handling and shipments.
  • Proficient financial analysis skills to correlate services, costs, and pricing.
  • Must possess very strong verbal and written communication skills, as well as demonstrated capabilities in negotiation and influencing. Must be able to effectively communicate with staff and management at all levels in addition to external parties.
  • Must be a self-starter and demonstrate strong initiative. Must be able to work effectively in a team environment with minimal supervision and able to adjust workload based upon changing priorities.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Senior Director, Quality Operations

We are seeking a Senior Director, Quality Operations to provide strategic leadership, operational direction, and ensure achievement of all functional accountabilities for the following departments: Microbiology, Quality Assurance and Validation, and Quality Control. This position is the Head of Quality, with oversight for ensuring compliance with US and global regulatory requirements (e.g., FDA and EMA) and for site decisions affecting product quality and sustainable cGMP compliance and keeping Senior Management aware of critical issues within areas of purview. Support Business Development objectives and manage Business Partner transition activities as appropriate.

Primary Responsibilities:

  • Establish, evaluate, direct, and maintain all Quality Systems to confirm compliance with regulations governing drug development and clinical studies for activities related to the manufacture, testing, and release of raw materials and clinical products.
    • Corporate Quality Systems include:
      • Exception Management (Deviations, CAPA, OOS/OOT, and Investigations)
      • Commercial and Developmental Stability Programs
      • Material Release, Shipment, and Inventory Management functions
      • Process, Equipment, and Cleaning Validation
      • Method Transfers and Method Validation
      • Change Control
      • Coordination of Regulatory Inspections and Audits (Internal and External).
      • Supplier/Vendor/Contract Laboratory Qualification Program and Management
      • QC Testing at Contract Labs
      • Regulated Documents and Records
      • cGXP Training (e.g., cCCP, cGLP, and cCMP)
  • Oversee, manage, coordinate, and prioritize activities of the Quality Unit and ensure information is appropriately communicated and adhered to by departmental staff.
  • Ensure enforcement of compliance with SOPs and cGXP for training of site personnel, all relevant site documentation (e.g, Batch Records, Validation Protocols), etc.
  • Facilitate successful interactions between the Quality Unit and other internal departments
  • Direct initiatives that support the goals of continuous improvement, enhanced efficiencies, compliance with established procedures (e.g., SOPs) and processes, and cost effectiveness.
  • Conduct Project Management activities for Product Technical Transfers and pipeline advancement.
  • Represent the Company as compliance/quality liaison for regulatory authorities, corporate partners, and other entities as required.
  • Establish Quality Agreements with business partners.
  • Review technological solutions.

Qualifications:

  • Bachelor's degree in engineering, life science, or equivalent required with at least 15 years of Quality Management/Compliance experience in the biotechnology or pharmaceutical industry preferred; advanced degree preferred.
  • Minimum of 5 years of progressively responsible management experience.
  • Team participation in technical transfers and product phase-forward and scale-up (Research and Development to Clinical to commercial) required; leadership preferred.
  • Prior experience interacting with or directly managing Regulatory Authority inspections.
  • Experience writing change controls, investigations/ CAPA, SOPs, protocols, reports, and validation documents is mandatory; Validation, GAMP, Part 11-compliant systems is a plus.
  • Strong leadership and ability to effectively communicate vision.
  • Ability to translate strategic plan into specific operational deliverables for timely implementation.
  • Knowledge of domestic and international regulations concerning GxP and Quality Systems, particularly concerning biologics, aseptic processing and cleanroom environments.
  • Experience in leading Quality organizations to meet metrics and financial commitments, while identifying problem areas and necessary actions to eliminate issues and mitigate risk.
  • Excellent managerial, interpersonal, and written and verbal communication skills
  • High proficiency with computer applications.
  • Experience in multiple phases of Clinical research and preferably Commercial Supply Chain.
  • Demonstrated leadership in Project Management, Technical Transfer, and GxP rollouts.
  • Strong agent of change with ability to work cross-functionally to achieve business outcomes.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Senior Manager or Associate Director, Data Management

We are seeking a Senior Manager or Associate Director, Data Management to provide leadership to the Data Management group and ensure the quality of all data management deliverables through compliance with regulatory requirements, applicable industry guidelines and internal Standard Operating Procedures. This individual will provide direct supervision of Data Management staff, represent Data Management in internal and external cross-functional team meetings, meetings with external vendors, and regulatory agencies meetings. Seek continuous improvement of the quality of group’s deliverables and effective use of applicable technologies within the group and the Company.

Primary Responsibilities:

  • Responsible for data management functions in support of clinical studies including but not limited to protocol review; CRF design, development, review, and approval; clinical trials application development and validation; external vendor oversight; and all activities required to ensure a high quality, analysis-ready clinical trial database.
  • Monitors compliance of data management activities with existing Standard Operating Procedures and addressing any compliance issues through training, development or updating of the necessary Standard Operating Procedures.
  • Review of existing Standard Operating Procedures to ensure compliance with regulatory requirements and applicable guidelines and address any gaps if any as necessary.
  • Creates thorough data quality checks and data review strategies to ensure integrity of the clinical data.
  • Develops and provides study tracking and metrics tools to improve monitoring of study progress and data quality.
  • Coordinates and prioritizes all data management activities according to the requirements of project timelines
  • Develops training programs to insure that all data management personnel are adequately trained.
  • Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites. Jointly with clinical study personnel, develops and prioritizes appropriate timelines for the completion of databases required for submission, report writing, and/or presentation purposes.
  • Functional management of Data Management personnel.

Qualifications:

  • Bachelor of Science degree(s) in area(s) related to one of the following: life sciences (e.g., biology, chemistry), health sciences, computer science, statistics, or mathematics. Master’s degree strongly preferred.
  • 7-10 years of related clinical data management experience with some prior experience at the supervisory/managerial level preferably in a biotech, pharmaceutical, and/or CRO environment. Experience must include strong working knowledge of data management practices; strong expertise in data capture; knowledge of SDTM models and experience in transforming raw data into approved standards; and familiarity with applicable US and global regulatory requirements. Skills in programming and generation of data listings and summary tables using SAS and other languages would be helpful.
  • Thorough understanding of all aspects of the data management functions including CRF development, query resolution, medical coding, and all activities associated with database lock.
  • Good working knowledge of EDC technology. Experience with initial implementation of EDC applications is not required but is highly desirable.
  • Thorough knowledge of applicable regulations, ICH guidelines, CDISC requirements and models such as SDTM, and clinical/scientific terminology common to biopharmaceutical setting.
  • Experience with developing data capture standard. Familiarity with CDASH is desirable.
  • Previous experience with direct supervision of data management personnel in the pharmaceutical/biotechnology or CRO industry is required.
  • Excellent interpersonal skills and problem solving capabilities. Strong project management and mentoring/leadership skills.
  • Strong organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.
  • Good verbal and written communication skills.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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QA Associate, Product Disposition

We are seeking a Quality Assurance Associate to be responsible for the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot. This individual manages the batch documentation package and maintains records. This position may also be cross-trained on the Raw Material Release/Clinical Shipments and Regulated Document/Training functions.

Primary Responsibilities:

  • Review production batch documentation package for lot release.
  • Communicate release status to appropriate personnel.
  • Prepare, revise, and maintain Certificates of Analysis (COAs).
  • Maintain controlled records.
  • Review Process Simulation (media fill) system as required.
  • Conduct changeovers in production area as required.
  • Inventory management.
  • Stability Data Review.
  • Participate in audits, investigations, corrective action/preventive action (CAPA), standard operating procedure (SOP) preparation/revision/review, and other projects as appropriate.
  • Participate in issue resolution and identify opportunities for process/system improvement.

Qualifications:

  • Bachelor’s degree in biology, chemistry, or related field, with 2 years prior GxP experience in a Biotechnological, Pharmaceutical, or Clinical environment; or equivalent combination of education and experience.
  • Background/familiarity in product disposition, batch record review, and/or raw material release strongly preferred.
  • Excellent written and verbal communication skills required, including Responsible Business Communication; scientific writing experience a plus.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with MS Office applications.
  • Ideal candidate will possess a strong customer service philosophy.

Starting salary range of 40k-50k, commensurate with experience, plus a comprehensive benefit package.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.

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QC Analytical Method Validation Specialist

We are seeking a QC Analytical Method Validation Specialist with experience designing, planning, and executing validation experiments and analyzing generated data.

Primary Responsibilities:

  • Defines validation strategy and is responsible for method validation for analytical methods including HPLC, cIEF, CE-SDS, ELISA, cell-based bioassays, and compendial methods.
  • Responsible for all areas of validation including protocol development, execution of protocol, interpretation of data, and generation of final report summarizing validation results.
  • Participates in execution of method validations.
  • Works collaboratively across organization for method readiness, performance, and trouble shooting.
  • Performs IQ/OQ/PQ as appropriate on QC equipment.
  • Investigates and writes Non-Conformance Reports (NCRs) when applicable.
  • Initiates/ approves Change Controls.
  • Develops, maintains, and revises relevant QC SOPs.

Qualifications:

  • PhD in biological sciences, chemistry, or related scientific disciplines with at least 10 years of relevant experience
  • MS or BS with at least 15 years relevant experience; or equivalent combination of education and experience.
  • Industry experience in method development and validation in support of development and/or commercialization of biopharmaceuticals.
  • Prior experience with capillary electrophoresis is required.
  • Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Must be able to work in a team environment and perform job responsibilities under minimal supervision.
  • Must have familiarity with FDA and ICH guidelines and be able to follow SOPs and cGMP guidelines.
  • Must be proficient with MS Office applications.

Physical Requirements and Working Conditions:

  • Environment: Work is performed in a GMP lab setting with exposure to a variety of chemicals. This role requires office work as well. May work around sera from patients. Repetitive motions are involved.
  • Physical: Must be able to maneuver/transport compressed gasses occasionally. Exert up to 20 lbs. of force occasionally and/or up to 10 lbs. of force frequently.
  • Equipment Used:
    • Office Equipment
    • Laboratory and/or Related Equipment (e.g., instrumentation, fume hoods, incubators, freezers, calibrators)
  • Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
  • Hearing: Hear in the normal audio range with or without correction.

Starting salary will be between 70-85K (commensurate with experience) and will be part of a total compensation package that includes excellent benefits.

United States work visa sponsorship is not available for this position. We can only consider your candidacy if you have authorization to work in the United States for any employer. At the initial time of application, please indicate your work authorization status. Please also note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization.

Local candidates preferred. No relocation assistance is available for this opportunity.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.

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Regional Clinical Research Associate (CRA)

We are seeking a Clinical Research Associate with 2-5 years of experience to be responsible for assisting with the implementation of clinical research projects. Oncology experience is a must.

This position requires 50%-75% overnight travel. The incumbent will be based out of our Corporate Headquarters in Morris Plains during initial training period, and several additional days in-house will be required throughout the year.

Primary Responsibilities:

  • Prepare and conduct study initiation, closeout, and monitoring visits at clinical investigative sites to ensure adherence to procedures, protocols, and project plan in accordance with FDA regulations.
  • Review, track, and manage study documents (Case Report Forms (CRFs), Serious Adverse Event (SAE) reports, clinical notes, and enrollment logs) for accuracy and completeness, as well as query resolution.
  • Responsible for one or more protocols with multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures; including investigator selection, reviewing regulatory documents, and preparing reports while meeting timelines/milestones.
  • Set up the study sites ensuring each site has the staff training to trial-specific industry standards, the required clinical trial materials, and the study specific regulatory documents.
  • Monitor clinical studies to ensure the quality and integrity of data entered in study documents verified against source documentation on-site.
  • Ensure all study drug shipments and study trial supplies (used and unused) are accounted for.
  • Update all relevant study tracking system on an ongoing basis.
  • Assist in the collection and timely resolution of SAE reports.
  • Assist with maintaining site and master study regulatory binders and study documentation.
  • Draft, compile, and verify clinical data for status reports when required.
  • Support compliance with study timelines.
  • Assist in preparing the necessary tools to maintain consistency in the study data across all sites.
  • Interact with sites to discuss study specifics, assist with IRB submission, oversee study start-up activities, etc.
  • Assist in the design of the CRFs.
  • Field phone calls and e-mails from sites and address issues in a timely manner.
  • Assist the Data Management group as needed to resolve queries, etc.
  • Make grant payments to clinical sites.

Qualifications:

  • Bachelor’s degree in biological science (nursing or other health-related discipline preferred) and 2-5 years related experience and/or training; or equivalent combination of education and experience. A medical or healthcare background is critical to success in this position.
  • Experience with all phases of clinical trials, particularly Oncology, first-in-man, Phase I/II trials; including investigational site management, data collection, and study protocol compliance.
  • Knowledge of GCPs and regulatory requirements.
  • Experience in clinical data interpretation and verification.
  • Ability to read and understand medical terminology, abbreviations, and records.
  • Excellent verbal and written communication skills.
  • Detail oriented with strong organizational, follow-through and problem-solving skills.
  • Ability to assess priorities and consistently meet deadlines while being self-motivated with the demonstrated ability to work independently.
  • Proficiency in Microsoft Office applications.
  • This position requires 50%-75% overnight travel. Must be available to complete training on-site at our Corporate Headquarters in Morris Plains, NJ. Additional days in-house will be required on a monthly basis.
  • Candidates residing in/around Colorado, Florida, New Jersey, or Texas are preferred.

Salary will be commensurate with experience, plus a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without specific salary information will not be considered.

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Please check back for future job postings.

Statement to Agencies and Recruiters

Immunomedics typically recruits candidates directly rather than with the assistance of a third party agency or recruiter. We will only pay a fee for candidates submitted for consideration by any method under the following conditions: 1) There is a current, signed agreement or contract in existence between Immunomedics and the agency/recruiter prior to the submission AND 2) The candidate was submitted directly for a specific, agreed‐upon search. If a candidate is submitted to Immunomedics without meeting the aforementioned conditions, we explicitly reserve the right to pursue and hire the candidate without any financial obligation to the agency or recruiter. All vendors, approved or not, must not contact or solicit our employees regarding recruiting.

At this time, we are not actively looking to engage with any new agencies or recruiters. If you still wish to send information for us to review, please forward the relevant documentation to hr@immunomedics.com OR mail documentation to Immunomedics, Inc., Attention HR Department, 300 American Road, Morris Plains, NJ 07950.


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Available Positions at Immunomedics