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Job type: Permanent

Discipline: Product development, Commercial Operations

Location: United States

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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