- GAP Solutions Inc (Rockville, MD)
- Position Objective: Provide services as a Scientific Program Manager in support of the overall functions of the Vaccine Translational Research Branch, ... Vaccine Research Program , Division of AIDS (DAIDS) within the National Institute...vendor and contract manufacturers follow FDA 21 CFR 210/211 cGMP , promptly address any gap, and document the outcome… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …**Who is USP?** The US Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts ... for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global… more
- Catalent Pharma Solutions (Baltimore, MD)
- …maintained in compliance with regulatory codes + In coordination with the EHS Manager , oversee environmental health and safety program in the laboratory, assist ... **Job Title:** Sr. Manager Upstream Process Development **City:** Baltimore **State** :...client projects starting from the development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of… more
- Food and Drug Administration (Silver Spring, MD)
- …and verbal conclusions to FDA components and industry regarding compliance with CGMP regulations and FDA establishment standards. Identify and assess emerging or ... a subject matter expert across multiple subject areas demonstrating advanced level scientific knowledge and provides consultation to management and staff to address… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Program Manager , DS business unit - Sterility Assurance is responsible for technical management and performance of the sterility ... across the network. and mitigation of quality risks. The Program Manager is a key advisor for...as needed. Personal Development + Represents BD at appropriate scientific and professional meetings. + May conduct Sterility Assurance… more
- Catalent Pharma Solutions (Harmans, MD)
- The ** Manager , Sterility Assurance,** will be responsible for quality assurance oversight of Aseptic Processing Program , Environmental Monitoring and Microbial ... expertise for the development and implementation of the site Sterility Assurance Program . + Develop, document and manage microbial control strategy for production… more
- Charles River Laboratories (Rockville, MD)
- …a career that you can feel passionate about. **Job Summary** The Proposal Manager will be responsible for creating customized proposal documents for prospective and ... existing clients. The Proposal Manager works alongside commercial operations, business development, and technical...on areas such FTE's, timeline, etc., to allow the program design, proposal generation, resource and timeline estimates, and… more
- Food and Drug Administration (Silver Spring, MD)
- …decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and ... regulatory program definitions. Evaluates the identification and characterization of drug...its formulation and product design. Applies a risk and scientific -based approach to evaluate the adequacy of formulation studies… more