Job Title: Associate Director, CMC Analytical Development
Location: San Francisco, CA
About The Client: Our client is a dynamic biotechnology company dedicated to developing innovative therapies for oncology. They are committed to advancing science and improving patient outcomes through our cutting-edge research and development efforts.
Position Overview: They are seeking an experienced and highly motivated Associate Director of CMC Analytical Development to lead the analytical development team. This role is critical in ensuring the quality and compliance of our biopharmaceutical products throughout the development lifecycle. The ideal candidate will have a strong background in analytical chemistry, CMC processes, and a proven track record of leading teams in a fast-paced biotech environment.
Key Responsibilities:
- Lead and manage the analytical development team, overseeing the design, validation, and implementation of analytical methods for drug substance and drug product characterization.
- Collaborate with cross-functional teams, including formulation development, quality assurance, and regulatory affairs, to ensure alignment on CMC strategies.
- Develop and execute analytical development strategies to support preclinical and clinical studies, ensuring compliance with regulatory requirements and industry standards.
- Evaluate and select appropriate analytical technologies and methods to meet project needs and timelines.
- Prepare and review regulatory submissions, including INDs and BLAs, ensuring analytical data meets regulatory expectations.
- Provide technical guidance and mentorship to team members, fostering a culture of scientific excellence and innovation.
- Stay current with industry trends, emerging technologies, and regulatory changes related to analytical development.
Qualifications:
- Ph.D. in Analytical Chemistry, Biochemistry, or a related field with 4 years of relevant industry experience; or a Master’s degree with 8 years of experience in a leadership role.
- Extensive knowledge of CMC processes, regulatory requirements, and analytical method development/validation.
- Proven leadership experience, with a track record of managing teams and projects in a biotech or pharmaceutical environment.
- Strong problem-solving skills and the ability to work collaboratively in a fast-paced environment.
- Excellent communication and presentation skills, with the ability to convey complex scientific information to diverse audiences.
What We Offer:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- A collaborative and innovative work environment
- The chance to make a meaningful impact on patients’ lives
