Associate Director, Process Development - REMOTE

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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