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Job type: Permanent

Discipline: Analytical Chemistry, Genetics & Genomics, Pharmacokineticists

Location: United States

Proclinical is seeking a remote Associate Director, Process Development for a leading biotech company.

Must be eligible to work in the US.

Job Responsibilities:

Lead process development activities at CDMOs to ensure cGMP clinical manufacturing processes are developed and executed to meet project timelines, budgets, and quality standards.
Monitor the manufacturing of drug substance and drug product.
Author module 2.3 and 3 sections of IND filings and ensure compliance with regulatory requirements.
Develop and implement analytical strategies for lot release testing and characterization, including mass spec and other related analytical techniques.
Collaborate with cross-functional teams to ensure timely completion of project milestones.
Provide technical expertise and guidance to junior team members.
Flexibility and a willingness to travel to CDMO and work international time zones is essential.

Skills and Requirements:

D. in Biochemistry, Chemistry, or related field with a minimum of 5 years of Biologics Process Development experience in a drug development company or Master's degree with a minimum of 10 years of Biologics Process Development experience.
Strong knowledge of bi-specific antibody therapeutics drug development, process development, cGMP manufacturing, and regulatory requirements.
Experience in authoring Module 2.3 and 3 CTD sections of IND filings is required and familiarity with regulatory standard and guidance documents for all phases of development is preferred.
Proven track record of managing CDMOs for drug substance and drug product development and manufacturing.
Strong knowledge of analytical techniques for lot release testing and characterization, including mass spec.
Excellent communication, organizational, and project management skills.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at +(1) 857-362-9542 or m.robinson@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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INDSCIC