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.

Validation Engineer

THIS IS NOT AN IT OPPORTUNITY. POSITION WILL BE IN THE QUALITY ASSURANCE & COMPLIANCE DEPARTMENT.

We are seeking a Validation Engineer to be responsible for the completion of assigned validation projects encompassing equipment, instruments, computers, cleaning, and process areas for the entire validation lifecycle.

Primary Responsibilities:

  • Satisfactorily complete assigned validation projects.
  • Compose validation plans, protocols, and reports.
  • Perform IQ/OQ/PQ of facility, including building management system and appropriate manufacturing and QC equipment; execute process/cleaning and specified system validations.
  • Write associated validation summary reports.
  • Investigate and write Non-Conformance Reports (NCRs) when applicable.
  • Write and review appropriate SOPs and other documentation as determined appropriate.
  • Initiate and complete Change Controls.
  • Participate in special teams and projects as necessary.

Qualifications:

  • Bachelor's degree in Engineering or Science and a minimum of 2 years post-educational validation experience in the biotechnology or pharmaceutical industry are required. Candidates without hands-on validation experience outside of their educational institution will not be considered.
  • Candidates must have experience managing the full lifecycle of validation projects, i.e. planning, execution, and creation of summary reports.
  • GMP experience is mandatory; familiarity with aseptic processing and clean room environments is strongly desired. Experience with autoclave and depyrogenation oven by using Kaye Validator is a plus.
  • Experience writing Change Controls, SOPs, protocols, reports and validation documents is required. Investigations experience is a plus.
  • Must possess excellent written and verbal communication skills.

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.

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. Salary will be commensurate with experience and will be part of a total compensation package that includes excellent benefits. Resumes submitted without salary information will not be considered.

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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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Quality Control Technician

We are seeking a Quality Control Technician to be responsible for Quality Control (QC) IEF and SDS-PAGE gel electrophoresis.

Primary Responsibilities:

  • Performs IEF and SDS-PAGE gel electrophoresis on manufacturing and stability samples including drug product, drug substance, and intermediates.
  • Analyzes, documents, and generates QC analytical reports for test results which are reviewed and approved by management.
  • Maintains documentation of gel electrophoresis testing.
  • Maintains QC lab equipment, such as UMAX system, to ensure that equipment is calibrated and functioning properly.
  • Prepares buffers and solutions for gel electrophoresis.
  • Orders laboratory supplies according to the needs of current projects.

Qualifications:

  • Bachelor’s degree in biology, chemistry, or related discipline and 1-3 years of experience in a Pharmaceutical (Biologics), Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience.
  • Prior cGMP/GLP training and experience working in a cGMP/GLP environment preferred.
  • Solid knowledge and proficiency with IEF and SDS-PAGE gel electrophoresis, analytical procedures, and associated instrumentation.
  • 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.

Starting salary will be between 40k-50k (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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Cell Culture Technologist

We are seeking a Cell Culture Technologist to participate in the development and operation of mammalian cell culture processes under both cGLP and cGMP conditions.

Primary Responsibilities:

  • Assist in cell line development and scale-up, adaptation, subcloning, serum-weaning, and screening.
  • Prepare and maintain small research cell banks and cGMP large production cell banks.
  • Perform cell culture expansion under cGMP for cell culture manufacturing in large bioreactors.
  • Assist in production of MAbs for research and clinical use using roller bottles or bioreactors.
  • Perform ELISA and other metabolite and/or process monitoring assays.
  • Assist in media and bench scale process development.
  • Assist with laboratory and supply upkeep.
  • Participate in group/department meetings and present results/diagnosis as needed.
  • Minimal weekend and/or holiday work required.

Qualifications:

  • Bachelor’s degree in biology or related discipline, with 0-3 years of hands-on experience in cGMP industry; or equivalent combination of education and experience.
  • Strong aseptic techniques and demonstrated ability in documentation and knowledge of cGMP cell culture development.
  • Must be adept at using hand tools.
  • 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 have good oral and written communication skills.
  • Must be organized and be able to troubleshoot.
  • Must have the ability to work both in a team and independently.
  • Must be proficient with MS Office.

Starting salary between 40- 45k 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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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