Bio-Therapeutic Production Project Manager US-MD-Bethesda

We are seeking a Biotherapeutic Production Project Manager to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in support of the overall functions of the Vaccine Production Program. 

Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs. 

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad. 

• Prepare VPP bulk drug candidate products for laboratory inventory in support of development and production of government vaccine and biotherapeutic investigational products, including:
  • Obtain purified bulk vaccine candidates/biotherapeutics or bioreagents from the VPP downstream group.
  • Verify all label information on the bulk from downstream is correct.
  • Determine the aliquoting plan for each lot of bulk received per direction of the Scientific Operations Manager (SOM) for VPP or designee.
  • Generate the correct number of labels per container size for each lot, and verify all information is correct.
  • Perform the aseptic filling/aliquoting for each lot of bulk in a biological safety cabinet.
  • Determine the storage location for each aliquoted lot (-80C, -30C, or 4C) as specified by either the SOM or designee.
  • Prepare products for shipment to outside collaborators, following all NIH/IATA/DOT regulations.
• Prepare all shipping documentation necessary and ensure that all NIH/NIAID collaboration agreements are stated on shipping documents, under direction of VPP SOM Manager and/or VPP Strategic Leadership Team.
• Aid in the processing of laboratory requests for commercially available goods (CAG) from VPP stockroom or equivalent.
• Perform weekly verification of CAG held by VPP Scientific Operations and notify the VPP SOM or designer.
• Aid in response to departmental requests for instrument service, under the direction of the VPP SOM or designer.
• Follow established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
• Perform miscellaneous job-related duties as assigned by either the SOM or designee including but not limited to performance of property checks, maintenance of service contracts on lab equipment, biological/chemical waste removal, equipment moving, package delivery and various inventory levels.
• Serve as a backup emergency responder for all VPP REES (alarm system) monitored equipment.
• Operate dolly/ pallet jack in loading and unloading supplies and equipment.

• Bachelor’s degree in Biology, Chemistry, with 2 years relevant experience or HS diploma with 6-8 years of relevant experience is required.
• Proficient in MS Office Suite.
• Familiar with general scientific/biotechnology laboratory supply requirements.
• Strong analytical capabilities to prepare inventory analyses.
• Strong communication skills to communicate with internal and external stakeholders.
• Must have the ability to work as a team member.
• Prior experience working in a biological safety cabinet and/or a laminar flow hood is required.
• Demonstrated experience/training in sterile technique for handling biological products is required.
• Hands-on experience with product candidate inventory management systems is required.
• Must have current up to date training in USDOT and IATA training for biological shipping.
• Current training in RCRA, DOT and HAZCOM (GHS) is preferred.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson’s Janssen, is required for this position.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.