- Proactively manage and oversee work at contract manufacturing and contract development organizations (CMOs/CDMOs) to successfully meet development and clinical production goals and timelines.
- Provide synthetic process and manufacturing technology expertise to design and execute development studies to optimize and scale up drug substance manufacturing processes.
- Lead successful technology transfers, process qualification, and validation at manufacturing sites.
- Drive early development drug substance physiochemical characterization, polymorph/crystal form selection and preformulation.
- Act as an internal subject matter expert (SME)to creatively solve problems, troubleshoot, anticipate issues, and provide contingency plans.
- Work closely with internal team members across Sagimet functional areas/departments to ensure Drug Substance and Raw Materials production is part of a robust supply chain to meet project goals and clinical supply requirements.
- Partner with Quality to review batch documentation, deviation reports, and investigations; and ensure drug substance batches comply with specifications, cGMPs, and regulatory requirements.
- Draft relevant CMC sections of regulatory documents including INDs, IMPDs, NDAs, and MAAs.
- Monitor project progress and regularly report to the Sr. VP, R&D.
- Other duties as assigned.
- BS/BA degree in Chemistry or related discipline and a minimum of eleven years of related experience, MS/MA degree in related discipline and a minimum of nine years of related experience; or PhD in related discipline and a minimum of five years of related experience; or equivalent combination of education and experience.
- Proven small molecule process development expertise with experience in clinical manufacturing, scale-up and technology transfer.
- Experience in Biotech/Pharmaceutical industry and a solid understanding of cGMP, quality, and regulatory requirements is required.
- Experience in working with and managing contract manufacturing organizations (CMOs).
- Experience in drug substance crystal/salt form evaluation and preformulation is an advantage.
- Team player with integrity and strong interpersonal skills who listens well and can facilitate good decision making.
- Results-oriented, proactive individual, who can diagnose issues, learn from mistakes, solve problems, and think strategically.
- Excellent organizational and project management skills
- Ability to communicate clearly and concisely verbally and in writing.
- Computer proficiency in Word, Excel, MS Project
- Travel required as needed to vendors, domestic and international
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Associate Director, Drug Substance Manufacturing
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Associate Director, Drug Substance Manufacturing - San Mateo, United States - Sagimet Biosciences
Description
About Us
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimets lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit
Position Summary:
The Associate Director, Drug Substance Manufacturing is responsible for supporting Sagimets drug substance activities, from early development through Phase 3 clinical supply to NDA registration activities and preparation for commercial manufacturing. This role is part of a team that leads all aspects of our Drug Substance activities at our contract manufacturing and contract development organizations (CMOs/CDMOs). In this role, you will provide synthetic and manufacturing technology expertise, drive process development/optimization, and lead technology transfers. Further, you will oversee drug substance clinical manufacturing, scale-up, registration batches, process validation, and commercial manufacturing preparedness.
Essential Responsibilities:
Education and Experience Requirements:
Compensation
The expected base salary range for this role is $155,000 - $195,000 Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Sagimet offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Sagimet through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with Sagimet prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Sagimet and Sagimet will not be responsible for any purported fees.
