Job Details
Senior Director of API Manufacturing
2025-10-24 Kelly Services South San Francisco,CAKelly 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: Director of Drug Substance Manufacturing
Position Type: Direct hire
Salary:
Director, $245,000-285,0000
Senior Director, $275,000 - $320,000
Overview
As Associate Director / Director, Drug Substance Manufacturing, you will be a strategic leader in drug substance process development, technology transfer, and external partnership management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC, youll be instrumental in overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success.
Youll thrive as part of a collaborative, fast-paced environment that honors accountability, transparency, and diversityall while working alongside top talent from the biotechnology sector.
Responsibilities
- 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.
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.
Competencies
- Adaptability in a team-oriented environment.
- Superior interpersonal and communication skills.
- Flexible and capable of thriving in a dynamic, smaller company setting.
If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research
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Why Kelly Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, were obsessed with where it can take you. To us, its about more than simply accepting your next job opportunity. Its the fuel that powers every next step of your life. Its the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifejust ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.