Director of Drug Substance Manufacturing

Director of Drug Substance Manufacturing

Director of Drug Substance Manufacturing

This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$225,000.00/yr - $285,000.00/yr

Direct message the job poster from Kelly

Senior Recruiter | Biotech Enthusiast and Talent Partner | PhD-level Scientist | Working Parent | Immigrant | Helping scientists answer the…

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

• Associate Director: $225,000-245,000
• Director, $245,000-285,0000

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, you’ll be instrumental in overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success.

You’ll thrive as part of a collaborative, fast-paced environment that honors accountability, transparency, and diversity—all 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.
• 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

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management, Research, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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