We are currently partnered with a Global leading CDMO that is looking to bring on Engineer II of Drug Product Manufacturing. They are looking to bring on someone that can contribute to the success of the clinical drug product manufacturing facility.
Requirements
- Complete assigned tasks associated with biologics DP clinical manufacturing, including buffer preparation, formulation compounding process, aseptic fill finish process, and other activities.
- Maintain the drug product suite in an inspection-ready state.
- Develop, author, review, and approve SOPs/protocols for manufacturing-related activities for GMP aseptic fill/finish operation.
- Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in aseptic fill/finish drug product production.
Qualifications
- Extensive knowledge and experience in drug product manufacturing, with a solid understanding of cGMP compliance requirements.
- Proven experience in risk mitigation planning and solving complex manufacturing operation-related problems.
- Track record of leading manufacturing teams in the industry.
- HS Diploma or equivalent required; BS/BA in life sciences, engineering, or related field preferred; or combination of relevant experience and education.
- 5+ years of relevant technical experience, with a minimum of 3 years in a Lead/Supervisory Role.
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