- Participate in planning and prioritizing GMP release and stability testing activities at Contract Manufacturing Operations (CMO) and contract testing laboratories.
- Review technical documents for clinical and commercial vaccine programs including method transfer, method qualification, and method validation, microbial reagent qualification, stability protocols and reports, and documents associated with regulatory filiings.
- Responsible for monitoring analytical method performance for clinical and commercial programs.
- Manage quality system events such as investigations, deviations, OOS/OOT, CAPA and change controls.
- Serve as SME for analytical methods, microbiological methods, and/or stability for global vaccines projects.
- Review, enter, verify, and analyze data for GMP release and stability testing of drug substances and drug product materials for global R&D and commercial programs.
- Lead investigations in support of OOS/OOT and deviations. Drive CAPA and change controls for both internal and external stakeholders.
- Participate in collaborative interactions with CMO/CTOs..
- Responsible for the primary review GMP documents such as microbial control plans, of stability reports, method validation protocols and reports, and other documents for communication with regulatory agencies.
- Responsible for technical assessment of methods for compliance to GMP requirements, guidance documents, and analyses of critical quality attributes.
- Assist with planning and execution of GMP sample management procedures, documenting transfers and facilitating material submission for release testing, stability studies and QA retains at CMO/CTOs.
- Support supplier audits, review quality agreements, review CoA, and assist with batch disposition.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- MS with a minimum of 4 years industry experience, or a BS with a minimum of 6 years industry experience.
- Knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses
- Knowledge and skills in chemistry and biochemistry, and/or microbiology Strong math skills required.
- Working knowledge of statistical software programs such as JMP is highly desirable.
- Excellent oral and written communication skills. Well organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
- Good time and project management skills, ability to oversee several projects simultaneously.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical office and laboratory bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 50 pounds).
- Willingness to travel to various meetings or CMO/CRO sites, including overnight trips. International travel may be required.
- Requires less than 5 % travel.
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