- 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.
- 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.
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body{font-family:Arial;font-size:12px;}h1,h2{color:#00698f;}Shaw Bakers is growing As a national leader in the commercial Premium Artisan Bakery category, we are searching for an experienced Product Developer to join our dynamic team, bringing their pastry/baking culinary experti ...
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Shaw Bakers is growing as a national leader in the commercial Premium Artisan Bakery category, we are searching for an experienced Product Developer to join our dynamic team. Bringing pastry and baking culinary expertise to our innovation group. · The candidate will bring extensi ...
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Lead late-stage drug product formulation and process development for Structure Therapeutics. · Develop robust and scalable drug product formulations and manufacturing processes. · Partner with CROs and CDMOs to develop commercial viable drug product processes. · ...
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- Work in company
Executive Director, Formulation and Drug Product Development
Only for registered members
This is a key role within the first phase of hiring for our Technical Operations team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical development, · Accountable for formulation and drug product developme ...
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Director, Drug Product Development - South San Francisco - Structure Therapeutics
Description
About Us:
Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
Position Summary:
Reporting to the Head of Drug Product Technical Operations, this position will lead late-stage small molecule drug product programs, including the development of robust and scalable drug product formulations and manufacturing processes. The role will focus on Late Stage program, PPQ, commercialization readiness, and life-cycle management activities. This individual will manage drug product-related activities with external CDMOs and internal stakeholders, ensuring effective coordination and execution across functions. The role will also support the authoring and review of relevant sections of regulatory filings, development reports, and risk assessments, contribute to the development of mitigation strategies, and support clinical and commercial supply planning.
Job Responsibilities:
Structure Therapeutics Inc. is an Equal-Opportunity Employer.
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $190,000-$257,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
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Product Developer
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Product Developer
Shaw Bakers- South San Francisco
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Product Developer
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Director, Drug Product Development
Only for registered members South San Francisco, California, , United States
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Global Development Product Lead
Only for registered members South San Francisco, CA
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Director, Drug Product Development
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Director, Drug Product Development
Only for registered members South San Francisco
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Director, Drug Product Development
Full time Only for registered members South San Francisco
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Director, Drug Product Development
Only for registered members South San Francisco
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Global Head of Product Development Regulatory
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Global Head of Product Development Regulatory
Only for registered members South San Francisco
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Global Head of Product Development Regulatory
Full time Only for registered members South San Francisco
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Global Head of Product Development Regulatory
Full time Only for registered members South San Francisco
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Global Head of Product Development Regulatory
Only for registered members South San Francisco
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Senior Software Engineer – Developer Productivity
Only for registered members South San Francisco, CA
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Senior Software Engineer – Developer Productivity
Only for registered members South San Francisco, California, USA
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Product Development
Only for registered members Howard St, San Francisco, CA , USA
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Developer Productivity
Only for registered members San Francisco, CA
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Developer Productivity
Only for registered members San Francisco, CA
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Developer Productivity
Only for registered members San Francisco
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Executive Director, Formulation and Drug Product Development
Only for registered members South San Francisco