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.

Job Responsibilities:

• 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 j.zafrani@proclinical.com.

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.

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