mRNA Vaccine Process Development SME
Tunnell Consulting, Inc.
Washington, DC
Full-time
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.
30+ days ago