Senior Analytical Scientist

We are seeking a Senior Analytical Scientist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.

CAMRIS International, LLC, is a dynamic medical research and 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 vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; 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

• Design, execute, and analyze experiments related to mRNA synthesis, purification, and formulation.
• Develop and optimize mRNA production processes, including IVT (in vito transcription) and downstream processing.
• Plan and conduct analytical tests for drug development and transfer the methods to CDMO.
• Collaborate with cross-functional teams, including formulation, analytical, and clinical development, to support the development of mRNA products.
• Analyze and interpret data and prepare technical reports.
• Perform IQ/OQ/PQ and maintain lab equipment.
• Follow safety procedures and good laboratory practice.
• Monitor and coordinate starting materials, drug substances, and drug product testing activities conducted at the PBF.
• Oversee method development for drug substances and drug products. Ensure methods are suitable, sufficient and development phase appropriate.
• Participate in method validation activities: review analytical methods, validation protocols, and reports at the PBF.
• Coordinate and manage analytical method transfers.
• Review analytical results and supporting documentation to ensure quality standards are met for release and stability testing of starting materials, drug substances, and drug products.
• Support analytical characterization activities (i.e., identification of new degradants).
• Draft and monitor project plans and timelines.
• Manage and coordinate reference standard supplies.
• Collaborate with the Quality Assurance department to ensure compliance.
• Reviews, as required, various technology transfer documentation with regulatory and other appropriate groups.
• Performs other related duties as assigned.

Qualifications

• BS/MS with 10-12 years of pharma industry analytical experience working within analytical development/validation.
• Excellent method development and validation skills and routine analysis.
• Ability to directly or indirectly manage small teams.
• Strong preference for an analytical scientist who has used a variety of analytical techniques/instrumentation.
• Strong preference for an analytical scientist who either has worked within a contract analytical lab working with external clients or has worked within a pharma company that outsourced some analytical work to external CDMOs.
• Ability to self-manage and take on new tasks.
• Ability to learn new analytical techniques by hands-on work and review published data.
• Ability to multi-task and hit project timelines.
• Excellent oral and written communication skills.

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.

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 the 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.