Scientist

CAMRIS•Bethesda, MD

18d•Onsite

About The Position

We are seeking a Scientist to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

PhD in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline is required.
Minimum of eight (8) years of experience in recombinant protein purification development for GMP clinical-phase products is required.
Demonstrated knowledge of maintaining accurate and detailed records.
Must be a team player who can effectively work with members from cross-functional departments.
Strong oral and written communication skills.
Familiarity with computer software including word processing and data evaluation.

Responsibilities

Oversee the development of downstream processes for VRC clinical candidates and the process tech transfer to the VCMP for clinical material generation for the VRC.
Provide project support to lead scientists and/or associates to develop downstream process methods that meet the product quality and recovery characteristics to guarantee successful production of clinical material.
Work with scientists and/or associates in troubleshooting and improving downstream methods during the development cycle. This includes efforts in designing optimization studies (DOE with JMP) and streamlining efforts to ensure timely development schedules.
Work closely with Project Managers to ensure downstream milestones are appropriately set and met on time.
Serve as a subject matter expert (SME) in guiding purification strategies for new vaccine or therapeutic mAb candidates (both internal to the downstream team and throughout the VPP).
Responsible for planning and overseeing the downstream processes for toxicology lot material production. This includes editing/approving all process protocols, managing execution thereof, and the generation of production reports following successful campaigns.
Coordinate closely with Manufacturing teams to ensure timely and scale appropriate Technology Transfer is achieved, by pursuing the following: Write/edit/review tech transfer documents (Process Descriptions/Process Flow Diagrams) to support VCMP downstream process Master Batch Record authoring.
Serve as Person in Plant or assigns team designee for initial VCMP production runs.
Serve as SME in VCMP downstream troubleshooting and facility fit calculations.
Serve as the VRC downstream SME in external collaborations for projects outside of VCMP-path clinical development
Work with regulatory team, as needed, to support IND submissions and other requests.
Oversee viral clearance strategies in relevant downstream processes and directs the viral clearance validation efforts (SEG evaluation of CRO vendors, scale-down method SOP/validation approval, etc.
Encourage and drive innovation to meet new downstream challenges and seeks to publicly distribute novel technologies through presentations at conferences and/or publication in peer-reviewed journals
Other duties as assigned.

Benefits

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

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