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.

Clinical Research Associate II (CRA II)

We are seeking a Clinical Research Associate with 5 years of experience to be responsible for assisting with the implementation of clinical research projects. This position requires 50%-75% overnight travel and will be based out of our Corporate Headquarters in Morris Plains when not traveling.

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 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.
  • Mentor junior staff members, as applicable.

Qualifications:

  • Bachelor’s degree in biological science (nursing or other health-related discipline preferred) and 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 understand medical terminology, read medical records, and understand medical abbreviations.
  • 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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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 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 up to 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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QA, 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, review test results, and determine release status.
  • Coordination of clinical shipments.
  • Preparation and circulation of controlled documents (e.g., specifications, labels).
  • Inventory management.
  • Sability Data Review.
  • Generation of associated reports.
  • Conduct changeovers in production area as required.
  • Participate in audits, investigations, SOP preparation/review, and other projects as appropriate.

Qualifications:

  • Open to entry level candidates with Bachelor’s degree in science; Biology/chemistry preferred.
  • Relevant GxP work experience gained in a Biotechnological, Pharmaceutical, or Clinical environment can be considered in lieu of a degree.
  • Excellent written and verbal communication skills required, including responsible business communication; scientific writing experience is preferred.
  • 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 40k-45k, 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.

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Pharmaceutical Manufacturing Technologist

We are seeking a 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:

  • Manufacture antibodies, antibody fragments, and conjugates
  • Maintain inventory of raw materials and supplies needed in manufacturing
  • Purify antibodies using ion-exchange and affinity column chromatography and DV20 Virus Removal Filtration
  • Prepare buffers (up to 200L each)
  • Maintain accurate batch records, log books, and log sheets
  • Write/revise batch records, buffer sheets, SOPs, and Material Specification Sheets (MSSs)
  • Fill Bulk Drug Substance aseptically
  • Maintain and calibrate daily all equipment needed during production
  • Monitor and assure adequate supply of glassware/components for manufacturing

For consideration, candidates must have Bachelor’s degree in Biology, Chemistry, or related discipline. Experience with aseptic technique required.

Strong preference will be given to candidates who offer prior industry/clean room experience.

Candidates should also possess excellent verbal and written communication skills and be detail oriented with strong organizational, follow-through, and problem-solving skills.

Starting salary 40k- 42k 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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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