Biologist

CAMRIS•Gaithersburg, MD

4d•Onsite

About The Position

We are seeking a Biologist to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Gaithersburg, 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

Bachelor’s degree in Bioengineering, Chemical Engineering, Biochemistry, or a related discipline.
5-7 years of experience in recombinant protein purification and mRNA-LNP development for GMP clinical-phase products.
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

Develop downstream (purification) processes, under the supervision of a project lead scientist, for recombinant proteins, virus vaccines, and virus-like particles (VLP) that may be used as clinical candidates.
Design and execute mRNA-Lipid Nanoparticle (LNP) process development studies for mRNA-lipid nanoparticle encapsulation.
Serve as SME with operation and optimization of microfluidic systems, e.g., Precision NanoSystem, Inc Ignite and Blaze, and/or Knauer NanoScaler Impingement Jet Mixers.
Develop scale down and scale-up operations to advance tech transfer to manufacturing and/or enable troubleshooting.
Screen and optimize tangential flow filtration processes for mRNA-LNP products to generate preclinical materials and drive tech transfer for clinical manufacturing.
Design and execute lipid screening studies to evaluate novel lipid components and formulations for use in pre-clinical safety and efficacy studies.
Collaborate with analytical and formulation scientist to characterize mRNA-LNP formulations and optimize process flows and sample stability.
Perform in vitro transcription reactions to generate mRNA products.
Purify research-phase recombinant proteins, virus vaccines, and/or virus-like particles in collaboration with other groups or external collaborators.
Work within the purification group to design, develop and optimize chromatography and filtration step unit operations to drive process development of clinical trial vaccine candidates and mAb products.
Collaborate with project management to ensure mRNA-LNP development milestones and study deliverables are met in a timely manner.
Work to prepare necessary materials (buffers, packed columns, etc.) for execution of downstream process activities.
Perform technology transfer of processes to VRC Pilot Plant for manufacture of clinical product through document generation and on-site support.
Write and review tech transfer documents, technical protocols, and reports.
Generate supporting documents, as necessary, for IND-filings and other regulatory needs.
Analyze and compile data, present at various group/department meetings.
Performs 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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