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.
- 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 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.