Associate Director, Technical Operations CMC Biologics
Proclinical is currently recruiting for an Associate Director of Technical Operations CMC Biologics for a leading biopharmaceutical company located in San Diego, CA.
- Technical oversight of the tech transfer, scale up, and manufacturing of a biological product at company CDMOs.
- Provide technical review and approval for manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports.
- Verify suitability, qualification and validation of processes at CDMOs and other external laboratories.
- Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions and facility inspections.
- Provide CMC development and manufacturing support on internal and external project teams.
- Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
- Write technical reports on a variety of process development related subjects.
- Assist in preparation of CMC sections of regulatory submissions.
Skills and Requirements:
- B.S. degree in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Equivalent combination of education and applicable job experience may be considered.
- 5 - 8 years of relevant experience in biologics manufacturing, scale-up, and late stage drug development.
- Manufacturing experience with microbial production, PEGylation, aseptic fill/finish, and lyophilization is a plus.
- Expert knowledge in process development, QbD, validation and technology transfer procedures.
- Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development.
- Broad knowledge and experience within the GMP environment and regulatory affairs.
- Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Excellent decision-making and collaboration skills with strong attention to detail.
- Six Sigma and statistical knowledge is a plus.
- Ability to travel 10-20% domestically and internationally.
If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.