Structure Therapeutics · 18 hours ago
Director, Drug Product Development
South San Francisco, CA
Full-time
Onsite
Director/Executive
$190K/yr - $257K/yr
12+ years expStructure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The position will lead late-stage small molecule drug product programs, focusing on formulation and manufacturing processes, while ensuring effective coordination with external partners and internal stakeholders.
BiotechnologyHealth CareMedicalPharmaceuticalProduct Research
Responsibilities
Lead late-stage drug product formulation and process development, including risk assessments and mitigation strategies (FMEA), application of Quality by Design (QbD) principles, PPQ planning and execution, commercialization readiness, and life-cycle management activities
Partner with CROs and CDMOs to develop robust, scalable, and commercially viable drug product processes; troubleshoot process variability and optimize manufacturing performance and yields
Collaborate with cross-functional teams to transition early-stage drug product assets into Late Stage development and commercial manufacturing platforms, applying strong working knowledge of oral drug delivery modalities to guide formulation, process development, and technical decision-making
Coordinate drug product deliverables with CROs and CDMOs, including pharmaceutical developability assessments, drug product development activities, and GMP manufacturing of clinical and commercial batches
Partner with Clinical and Supply Chain teams to forecast demand and ensure timely supply of investigational medicinal products (IMPs)
Oversee GMP manufacturing activities at CDMOs for clinical and commercial batches, including establishment and deployment of continuous process verification (CPV) programs for drug product
Support CMC regulatory submissions (e.g., INDs and NDAs) by contributing high-quality, submission-ready drug product sections and associated development documentation
Oversee CRO and CDMO activities to ensure compliance with cGMPs, FDA and ICH guidelines, internal SOPs, and applicable global regulatory requirements
Build and maintain strong internal and external development networks, including CROs, CDMOs, and academic collaborators; prepare and deliver technical presentations at internal forums and external scientific or industry conferences
Qualification
Required
Ph.D. or M.S. in Pharmaceutics, Pharmaceutical Sciences, or a related discipline
Minimum of 12 years of experience in drug product development within the biotech or pharmaceutical industry, with demonstrated application of cGMP principles
Extensive hands-on experience in small molecule drug product development, including formulation, process development, and scale-up
Direct experience planning and executing drug product PPQs, as well as authoring and/or reviewing drug product sections of NDAs
Strong expertise in drug product formulation and process technologies, scale-up principles, and process analytical technologies
Experience with conventional and advanced drug product packaging technologies, including primary and secondary packaging systems, to support clinical and commercial supply
Demonstrated ability to critically evaluate complex analytical and development data and to troubleshoot formulation, process, and manufacturing challenges
Proven track record of working with and managing CROs and CDMOs to support development, scale-up, and GMP manufacturing activities
Experience preparing and delivering scientific posters and technical presentations for internal governance forums and external scientific or industry conferences
Experience operating effectively in a fast-paced, science-driven, and entrepreneurial environment, with strong execution focus and professional integrity
Benefits
Annual performance incentive bonus
New hire equity
Ongoing performance-based equity
Medical, dental, and vision insurance
401(k) match
Unlimited PTO
A number of paid holidays including winter shutdown
Company
Structure Therapeutics
Structure Therapeutics specializes in the discovery and development of drugs against a type of targets called GPCR.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.77BKey Investors
Biotechnology Value FundQiming Venture Partners
2025-12-09Post Ipo Equity· $747.5M
2024-06-05Post Ipo Equity· $547.4M
2023-09-29Post Ipo Equity· $300M
Leadership Team
Raymond Stevens
Chief Executive Officer
Jun Yoon
Chief Financial Officer
Recent News
2026-02-06
2026-02-04
Company data provided by crunchbase