Job Description

Overview

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.

Responsibilities

• Support the Downstream Process Development (purification) group of the Vaccine Production Program (VPP) at the Vaccine Research Center.
• Lead development of mRNA drug substance process, including purification of pDNA, generation and purification mRNA constructs and their subsequent LNP encapsulation.
• Collaborate with formulations team to enable identification and selection of appropriate lipids and LNP composition for downstream development activities.
• Plan and execute design-of-experiments (DOE) studies & high-throughput screening studies for purification process improvements and advancements including parameter optimization, scale-up, process operating window determination and process capability evaluation.
• Lead efforts within the purification group to design, develop and optimize cell culture clarification (depth filtration and/or continuous centrifugation), chromatography, Tangential Flow Filtration (TFF), and Normal Flow Filtration (NFF) processes for all clinical trial vaccine candidates, including antibodies and subunit or nanoparticle vaccines.
• Oversee execution of viral clearance validation studies to support IND-submission and collaborate with external stake holders (VCMP/Vendors/CROs/CDMOs) on study logistics.
• Perform and support purification of research-phase recombinant proteins, mRNA vaccines, virus vaccines and/or virus-like particles in support of other groups at the VRC.
• Interface with key stakeholders (internal and external) to define development strategies and key milestones.
• Clearly communicate results and recommendations to collaborators, colleagues, managers, and senior management, leading project decision-making.
• Present findings at internal department level to institution level meetings and seminars.
• Author and/or review technology transfer documents in support of GMP manufacturing.
• Author and/or review relevant sections of IND submissions.
• Contribute to research publications through internal and external collaborations.
• Pursue novel technologies to advance the capabilities of the VPP.
• Review and publish technical reports and method protocols.
• Write and review process batch records for toxicology batch productions.

Qualifications

• Ph.D. in Biochemistry, Chemical Engineering, or other life sciences.
• Three to five (3 – 5) years of experience in industry-related downstream development lab.
• Prior mentorship experience with proven leadership abilities in team-oriented environment.
• Ability to navigate ambiguity and synthesize actionable next steps to move programs and strategies forward.
• Experience with mRNA IVT and purification.
• Proficiency in commonly used techniques and tools for biologics purification and characterization, including column chromatography, TFF, NFF, UV-Vis spectroscopy, etc.
• Demonstrated knowledge of maintaining accurate and detailed records.
• Strong organization, communication, and interpersonal skills, with the ability to drive projects in a highly collaborative work environment.
• Good understanding/knowledge of the overall drug development process, cGMP, and regulatory requirements.
• Familiarity with automation technologies and high-throughput techniques relevant to biologics production and process analyses.
• Experience writing technology transfer documents and IND submission sections related to downstream processes.
• Knowledge of the process scale-down and scale-up.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Ability to lift or carry less than 25 pounds, push or pull less than 25 pounds, reach above shoulder level, and use both hands.
• Must be able to stand or walk more than 25 of 30 minutes, bend repeatedly, and climb.
• Must have depth perception, correctable near vision, and distinguish basic colors.
• Must be able to perform repetitive activities.
• Ability to work alone or closely with others, work on ladders or scaffolding, and work with hands in water.
• Will be required to be in contact with lasers in instrument and work with corrosive substances, inorganic dust and powders, heavy metals, plastics, solvents and sensitizing agents.
• Must be able to wear personal protective equipment (PPE), including gloves, face shields/goggles, safety glasses, safety shoes, lab coat and disposable dust/surgical mask.

Please submit your resume online at . 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.

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.

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.

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