mRNA Vaccine Process Development SME

Subject Matter Expert -mRNA Vaccine Process Development / Manufacturing

This position will serve as a scientific / technical advisor as follows :

• As part of an interdisciplinary team, assist BARDA contractors in developing valid, high-yielding and economical processes as well as appropriate analytical methods for characterization of mRNA vaccines.
• Provide input on CMC aspects of mRNA vaccine product development plans / proposals for feasibility, assist in the rating and selection of projects against government needs, and assist in the post award monitoring of project execution against set plans and schedules
• Review and advise on development of stable / effective / appropriate final drug product formulation strategies
• Review and advise on the development and validation of analytical procedures, and development of specifications
• Review and advise on the development of stability programs and analysis of stability data
• Assess design and operation of manufacturing facilities for compliance with cGMP
• Evaluate contractor’s risk management program(s) for product development processes and assist in their modification
• Monitor quality assurance and regulatory compliance approach and performance for contracted projects
• Perform site visits / technical audits with the government’s Contracting Officer (CO) at contractor’s facilities, and / or facilities of subcontractors
• Monitoring compliance with contract requirements, federal regulations, and FDA and ICH CMC guidelines
• Prepare draft Statements of Work (SOW) for upcoming Requests for Proposals (RFP), and assist offerors in their development of proposed SOW’s

Desirable Expertise :

• Mid and late stage mRNA vaccine and other biopharmaceutical product development, process validation and manufacturing including the following areas :
• Process development and scale-up
• Formulation development Analytical test development for evaluation of product characteristics such as concentration, potency or activity evaluation of in-process, drug substance and drug product samples
• Process characterization and evaluation of new technologies
• Aseptic vial / syringe / other fill and finish validation and manufacturing operations for biopharmaceutical liquid and / or lyophilized formulations
• Experience in manufacturing technology transfer between development and manufacturing operations and / or between facilities or external partners / collaborators
• Proven written and verbal collaboration skills with a demonstrated ability to interact and provide influential technical recommendations

Requirements :

Education : . in Pharmaceutical Sciences, Biochemistry, Virology, Microbiology, or equivalent Life Sciences discipline preferred or a .

in a Life Sciences discipline with sufficient experience in biopharmaceutical product development and manufacture

• A minimum of 10 years biologics development and / or manufacturing experience is required
• Ability to travel up to 10% of the full time employee schedule

This position requires either . Citizenship or a Permanent Resident Green Card.