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.
- SAS Programmer
- Clinical Data Manager
- Validation Engineer
- Clinical MD
- Cell Culture Scientist
- Sr. Director/Vice President, Regulatory Affairs
- Maintenance Mechanic: 3rd Shift Weekend Position (Part-Time)
We are seeking a SAS Programmer to be primarily responsible for the programming and generation of data listings and summary tables. This position requires a good working knowledge of the SAS software system including but not limited to SAS/BASE, SAS/STAT, and SAS/GRAPH, and the ability to work in a multi-disciplinary team environment.
Primary Responsibilities:
- Perform SAS programming functions in support of clinical studies.
- Create SAS programs to list and summarize clinical data in a timely fashion in accordance with project timelines.
- Participate in the review/design of databases to assure conformance with study protocols and CRFs.
- Participate in data quality assurance and control (QA/QC) and its documentation.
- Interact with outside vendors/CROs on programming/SAS database issues as assigned.
- Participate in other programming or data-related duties as assigned.
Qualifications:
- Minimum of B.S. degree(s) in area(s) related to one of the following: Programming, Computer Science, Statistics, Mathematics, or Science, in that order.
- Minimum of 3 – 5 years of experience. Prior work experience should include the programming and generation of data listings and summary tables using SAS preferably in a biotech/pharmaceutical/CRO environment.
- Must be a self-starter with excellent analytical, communication (written and verbal), and problem-solving skills, well organized, flexible, and a solid team player.
- Computer Programs/Software: 1: MUST HAVE’s: Good working knowledge of the SAS software system including but not limited to SAS/BASE, SAS/STAT, and SAS/GRAPH; Basic understanding of standard database/CRF structures and data management (DM) processes.; Working knowledge of MS Access, Excel and Word. Knowledge of PowerPoint and VISIO would be highly desirable.
2: Preferred: Knowledge of CDISC standard would be highly desireable. Working knowledge of clinical/scientific terminology common to biopharmaceutical setting preferred. Familiarity with the creation of CRFs and CRF review preferred.
United States work visa sponsorship is not available for this position. 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.
This position is responsible for overseeing all functional aspects of the Biostatistics & Data Management group. There is direct responsibility for ensuring data quality for ongoing clinical studies. As such, this role requires a sound working knowledge of clinical data management processes and database systems as well as the ability to work in a multi-disciplinary team environment.
Primary responsibilities:
- Perform clinical data management functions in support of clinical studies.
- Oversee the design and creation of CRFs to ensure data capture is consistent with protocol requirements.
- Functions to include some or all, but not limited to: Data review, protocol/amendment review, CRF design and creation, CRF review, data entry, database review and validation, query generation and resolution, and validation of study results to achieve database finalization.
- Oversee the data management work being performed by external vendors or contract research organizations (CROs).
- Coordinate and provide appropriate training for all personnel in the group.
- Review, create and/or update of departmental documentation including but not limited to SOPs and training guidelines.
- Coordinate with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites. Develop and prioritize jointly with clinical study personnel appropriate timelines for the completion of databases required for submission, report writing and/or presentation purposes.
- Interact with external laboratories in coordination with clinical study personnel to ensure that appropriate laboratory evaluations are being collected in accordance with protocol requirements and consistent with GCP and/or approved SOPs.
Required Qualifications:
- BA/BS or MA/MS degree in Life Sciences/Biology/Medical Science with a working knowledge of the clinical/scientific terminology and methodology common to the biopharmaceutical setting.
- Minimum of 4-5 years of data management experience working in a clinical research or healthcare setting preferred, with solid understanding of the clinical development and data management processes; or equivalent combination of education and experience.
- Must have a good understanding of CRF and clinical database structures, and data management processes including CRF review, query generation and resolution.
- Knowledge of MS Excel, WORD, ACCESS and PowerPoint is essential.
- Knowledge of MedDRA coding and CDISC standard. SAS knowledge is a plus but not mandatory.
- Must be able to manage multiple projects concurrently with ability to adjust project priorities based on changing needs and timelines.
- Good analytical, communication, technical and interpersonal skills, with superior attention to detail and focus on quality.
- Ability to coach, mentor, and train other department personnel.
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 including excellent benefits.
United States work visa sponsorship is not available for this position. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in the United States and in the position you seek.
We are seeking a Validation Engineer to be responsible for the completion of assigned validation projects encompassing equipment, instrument, cleaning, and process areas for 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.
Required Qualifications:
- Bachelor's degree in Engineering or Science and 2 years hands-on validation experience in the biotechnology or pharmaceutical industry are required.
- 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. 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. Salary will be commensurate with experience and will be part of a total compensation package including excellent benefits.
We are seeking a Clinical MD to be involved in the planning and implementation of the Company’s clinical development program. This individual will participate in the design of all clinical trials necessary to verify product utility, safety and efficacy; and ensures that the scientific method is reflected in clinical protocols, data collection, and analysis. This individual will also be involved in the interpretation of findings.
Primary Responsibilities:
- Participates in the planning and coordination of world-wide clinical trials program.
- Prepares summaries of clinical data for regulatory submissions.
- Monitors progress of clinical trials relative to protocol preparation, recruitment of sites, patient accrual, and reporting, and writes protocols and investigator brochures; Takes corrective action to ensure timely completion.
- Prepares manuscripts and scientific papers on the Company’s products and clinical findings.
- Makes presentations and represents company at various industry or association meetings.
- Furnishes information needed for Clinical Research/Operations, in preparation of clinical documents and presentations; and to Regulatory Affairs, in preparation of regulatory documents.
Required Qualifications:
- M.D. with Board Certification in Oncology, Immunology, Hematology or Rheumatology. Otherwise, Doctorate (Ph.D.) degree or equivalent; or more than 10 years related experience and/or training; or equivalent combination of education and experience
- Strong analytic and writing skills with publications
- Experience in oncology and autoimmune diseases
- Biotechnology and/or pharmaceutical industry experience
- Experience with Phase I – III clinical trials
- Knowledge of GCPs and regulatory requirements for clinical trials
- Participation in large multi-center and/or global trials, investigational site management, data collection and interpretation, and study protocol compliance
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 including excellent benefits and stock options.
United States work visa sponsorship is not available for this position. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in the United States and in the position you seek.
POSITIONS WILL BE IN THE CELL CULTURE DEPARTMENT
We are seeking a Cell Culture Process Development Scientist to contribute to the development and optimization of fed-batch cell culture medium and processes used for the manufacture of monoclonal antibodies.
Some of the associated responsibilities will be:
- Conduct shake flask/bench-scale bioreactor experiments for the medium development and the process development/characterization/validation work.
- Maintain and expand cell lines; construct small research cell banks and large production cell banks.
- Perform screening of the best clones for new cell lines using the fed-batch process.
- Develop and optimize in-house media/feed.
- Write/revise SOPs and technical reports.
- Collaborate closely with Cell Line Development, Purification, and Bioanalytical/Quality Control groups.
- Assist in upkeep of laboratories.
Required Qualifications:
- MS in Biological/Chemical Engineering, Biotechnology, Biological Sciences or a related disciplines with 3-5 years of experience OR Ph.D. in Biological/Chemical Engineering, Biotechnology, Biological Sciences or a related disciplines with 1-3 years of experience. Experience must be in the area of mammalian cell culture / cell culture process development in a cGMP biopharmaceutical environment.
- Must have excellent aseptic skills and experimental/troubleshooting aptitude.
- Familiarity with cGMP and DOE (Design of Experiments) is essential.
- Good written and verbal communication is required, as well as good interpersonal skills with the ability to work in a team environment.
Salary will be commensurate with experience, plus a comprehensive benefit program.
United States work visa sponsorship is not available for this position. 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.
We are seeking a dynamic Sr. Director/Vice President, Regulatory Affairs who will be expected to assure that all government and international report systems and documentation comply with regulatory requirements for diagnostic imaging and therapeutic biological products.
Primary responsibilities:
- Develops content and format for regulatory submissions, such as INDs (Investigational New Drugs), EU CTAs (European Clinical Trial Applications), BLAs (Biologic License Applications), NDAs (New Drug Applications), EU Marketing Authorization Applications, related supplements and amendments, and briefing documents for scientific advice meetings.
- Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments.
- Negotiates directly with regulatory authorities regarding company's filings.
- Reviews and approves technical data, and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
- Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.
- Serves as regulatory affairs representative to provide input on Phase I, II, and III filing activities and to ensure that report systems are maintained.
- Interacts with FDA, EMA, NRC, state and local authorities.
- Coordinates with other departments, corporate or marketing partners, and international offices to achieve project goals.
- Reviews regulatory publications to keep apprised of new regulatory developments.
- Oversees collection of clinical and regulatory data for annual reports.
- Assists in the preparation of Company responses to regulatory agencies’ questions.
- Assists in the preparation of CMC and Preclinical Amendments.
Required Qualifications:
- Ph. D. or equivalent in the life sciences
- 10+ years of industrial experience in all aspects of regulatory affairs in a biotechnology or pharmaceutical setting
- Proven track record of effective collaboration with regulatory agencies, fluency in US and EU regulations, and extensive experience with biologicals
- Outstanding leadership, presentation, communication, and analytical skills and the demonstrated ability to work effectively with internal and external partners
- This role will heavily interact with Clinical Research, R&D, Biostatistics and Data Management, QA, QC, Manufacturing, the FDA and EMA, and our licensing partners.
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 including excellent benefits and stock options.
United States work visa sponsorship is not available for this position. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in the United States and in the position you seek.
POSITION WILL BE IN THE FACILITIES DEPARTMENT
We are seeking a highly responsible Maintenance Mechanic with a NJ High Pressure Boiler License for a 3rd Shift Weekend position (Fridays and Saturdays 10pm – 6:30am). 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; Proven 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 $27 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.
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.
EOE MFDV
