Kelly® Science & Clinical is seeking an Associate Director/Director of Drug Substance Manufacturing for a direct hire opportunity with a leading biopharmaceutical company in South San Francisco, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Hybrid, onsite in South San Francisco, CA, 3 days/week.
Position Title: Associate Director/Director of Drug Substance Manufacturing
Position Type: Direct hire

QUALIFICATIONS

• PhD in Organic Chemistry or related discipline.
• 10+ years of success in pharmaceutical process development, drug substance manufacturing, and technology transfer; experience with both small molecules and oligonucleotide therapeutics preferred.
• Deep expertise in cGMP standards, with strong working knowledge of US FDA, EMEA, and ICH regulatory guidelines.
• Proven ability to manage CDMO/CRO partnerships and external manufacturing relationships.
• Track record of authoring, reviewing, and supporting regulatory documentation for global drug development.
• Outstanding scientific knowledge, critical thinking, communication, and project leadership skills.
• Adaptable to a dynamic work environment; passionate about contributing to life-changing therapeutics.

• Process Leadership: Lead end-to-end process development and supply chain strategy for small molecule and oligonucleotide drug substances, supporting clinical and eventual commercial launches.
• Regulatory Contribution: Author and review IND/IMPD and other relevant regulatory documentation, effectively gathering and presenting scientific data for global regulatory submissions.
• External Partnership Management: Oversee productive collaborations with Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and key vendors to ensure consistent, compliant, and high-quality API supply.
• Operational Excellence: Initiate and implement process optimizations, resolve manufacturing challenges, and ensure cost, safety, quality, and sustainability targets are met or exceeded.
• Quality Collaboration: Work closely with Quality Assurance and cross-functional partners to drive SOP development, specification setting, and adherence to established quality standards.
• Team Empowerment: Serve as a mentor and subject matter expert within CMC, fostering best practices in a multidisciplinary environment.