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.

Quality Assurance 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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Weekend Maintenance Mechanic: 2nd Shift (Part-Time)

We are seeking a highly responsible Maintenance Mechanic with a NJ High Pressure Boiler License for a 2nd Shift Weekend position (Saturdays and Sundays 2pm – 10:30pm).

Primary responsibilities will include installing, maintaining, and repairing the heating, ventilation, and air conditioning systems; regular inspection of piping, valves, and other related equipment; maintaining the water and steam systems; and assisting with the overall maintenance of our building.

The successful candidate will have the ability to problem solve to correct building system issues and provide alternative solutions; ability to multi-task with attention to detail and work independently; ability to bend, stoop, climb a ladder, kneel, lift weight of up to 50 pounds, stand, and walk; familiarity with blueprints and schematics is a plus.

A NJ high pressure boiler operator’s license is a requirement. We cannot consider candidates who require an upgrade from a NJ low pressure boiler operator’s license.

This position requires an educational background normally equivalent to a high school education with apprenticeship or course work in skills/trades and at least 2 years of relevant work experience in building maintenance of HVAC & refrigeration, plumbing, electric, and carpentry. Experience with water purification systems (WFI Water) is highly valued and strong experience in refrigeration is desired. Additional relevant licenses and certifications will be a plus.

Hourly rate up to $29 commensurate with experience.

Please apply only if you meet all of the required qualifications listed above and provide salary expectations and confirmation of your NJ high pressure boiler operator’s license at the time of application.

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Senior Clinical Safety Associate

We are seeking a Senior Clinical Safety Associate to be responsible for handling all aspects of clinical safety associated with Company-sponsored and Investigator-sponsored clinical trials.

Primary Responsibilities:

  • Primary contact for clinical safety-related activities for both Immunomedics-sponsored trials and Investigator-sponsored trials.
  • Chairs Immunomedics’ quarterly safety meetings; tracks and distributes meeting minutes.
  • Reviews and processes serious adverse events (SAEs) in accordance with the Code of Federal Regulations, European guidelines, and Company requirements.
  • Generates case narrative derived from SAE report form and case report forms (CRFs).
  • Completes reports for SAEs.
  • Prepares, tracks, and follows-up with expedited safety reports to regulatory agencies and/or partners.
  • Creates and maintains clinical safety database and ensures that this information is made available to study management colleagues.
  • Reviews and provides assistance with MedDRA coding as needed.
  • Reconciles clinical safety databases with data management database and contract research organization (CRO) safety database as needed.
  • Defines and initiates follow-up through the appropriate channels (direct interactions with the monitor or site as necessary).
  • Writes queries and follows-up for resolution as needed.
  • Tracks cases to completion.
  • Maintains filing system integrity for hardcopy reports.
  • Assists with reconciliation of non-serious adverse events in clinical and safety databases.
  • Establishes and maintains good working relationships with associated groups; especially Regulatory, Data Management, CROs, and development partners.
  • Participates in third-party visits (e.g., audits and inspections) as required.
  • Develops procedural documentation, standard operating procedures, and guidelines.
  • Evaluates process optimization opportunities.
  • Furnishes information needed for Clinical Research in preparation of clinical documents and presentations and to Regulatory Affairs in preparation of regulatory documents.

Qualifications:

  • Bachelor’s degree in biological science (health-related discipline preferred) or appropriate licensure (RN) required. Master’s degree in nursing, public health, or medicine preferred.
  • 5+ years of experience in clinical safety and pharmacovigilance in the biotechnology or pharmaceutical industry.
  • Prior safety experience in Phase I – III clinical trial settings (NOT post-marketing).
  • Knowledge of medical terminology and disease pathology for review of safety information and preparation of communication to Investigators.
  • Familiarity with MedDRA.
  • Thorough knowledge of clinical safety including ICH/FDA/EMEA regulations concerning safety reporting.
  • Relational database experience desirable (e.g., ARGUS or Aris-g).
  • Excellent verbal and written communication skills.
  • Detail oriented with strong organizational, follow-through, and problem-solving skills.
  • Ability to work effectively with others as well as being able to work independently.
  • Ability to assess priorities and consistently meet 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. Please provide salary history and/or expectations when applying. Resumes without salary information will not be considered.

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

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.

Immunomedics, Inc. is an Equal Opportunity Employer.

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Clinical Research Associate (CRA)

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 Clinical Safety Manager in the collection and timely resolution of SAE reports.
  • Assist Clinical Trial Associate 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 the Director of Clinical Research in preparing the necessary tools to maintain consistency in the study data across all sites.
  • Interact with sites to discuss study specifics, assist with Institutional Review Board (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 investigative 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.
  • 50-75% overnight travel but the position will be based out of Morris Plains, NJ when not traveling.

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

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

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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Pharmaceutical Sanitization Technician (Part-Time)

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

Primary schedule will be 12pm-5:30pm, Monday through Friday.

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), 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 self-motivated and able to work with minimal supervision both independently and in a team setting.
  • 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.

Hourly rate commensurate with experience. Please provide compensation history and/or expectations at the time of application.

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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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