- Responsible for managing the development of chemical processes, technology transfer, and manufacturing of drug substances and Drug products at CDMOs.
- Responsible for identification, selection, and management of CROs and CDMOs, for clinical and commercial manufacturing of API and Drug Products through proper RFP process, negotiation, and due diligence of selected CDMOs.
- Works with Regulatory, QA and senior management to develop, refine, and ensure compliance with GMP and relevant regulations in US and Global regulatory agencies as applicable.
- Review and approve master and executed batch records, analytical method validation protocols, campaign reports from all manufacturing activities, analytical release testing, stability studies, and investigations.
- Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives. Work with project team(s) to identify API requirements and manage and optimize realistic project timelines.
- Provide comprehensive project analysis to executive management as required.
- Communicate effectively within cross-functional project teams at DermBiont including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Project Management, Clinical, IP, Legal, finance, and Regulatory.
- Maintain knowledge of current best practices of small molecule NCE product manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate for stable topical formulation development.
- Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality. Design and execute the development plan to support global submissions.
- Periodic Travel (domestic and international) to CRO/CDMO for the oversight of development activities and manufacturing.
- Ph.D. or MS in Chemistry or related field, e.g., Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or Chemical Engineering, with 12+ years' experience in CMC drug development and manufacturing.
- Minimum of 8 years of experience in a leadership position in CMC/Product Development.
- Demonstrated experience in successfully bringing small molecule CMC development through clinical phases to post commercial launch.
- Significant experience working with external CROs/CMOs
- Extensive development experience with API chemical synthesis Formulation/Drug Product Process Development, and Analytical Operations. Topical product development experience is a plus.
- Experience and knowledge of regulatory submission (IND, IMPD, and/or NDA)
- Demonstrated scientific knowledge relevant to the development and manufacture of drug products and management of clinical trial supplies.
- Extensive understanding in the areas of manufacturing, validation, tech transfer, quality, supply planning, and Tech Ops business systems
- Working understanding of cGMP, GLP, GCP, and GVP compliance requirements associated with U.S., EU, ICH, and other pertinent regulatory agencies.
- Strong leadership skills, including demonstrated ability to work cross-functionally with internal and external resources and to influence all levels of an organization.
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Senior Director CMC - Emeryville, United States - DermBiont
3 weeks ago
Description
Organization:
DermBiont's mission is to become the world's leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined mechanisms of action. DermBiont is a clinical stage biotech company with multiple active INDs enabling multiple Phase 2 clinical trials. The two lead products are for the treatment of seborrheic keratosis and for the treatment of hyperpigmentation disorders of the skin. The company has decades of combined team experience to select and develop first-in-class assets with the highest probability of success in the clinic, defining clear regulatory strategies, and conducting efficient clinical trials. DermBiont works continually to create an environment that supports and empowers our employees to do their best work.
Overview:
We are seeking a Senior Director of CMC to lead all CMC technical operations that includes, API synthesis, formulation, analytical method development, and CMC regulatory operations, for small molecule New Chemical Entity Products (NCE) from pre-clinical through commercial development. Dermbiont currently has two topical small molecule programs in phase 2 clinical trials.
This is a hands-on, high profile, and impactful role, with the responsibility of CMC development activities from concept all the way to scale up and tech transfer to GMP manufacturing. This role will report to the Senior Vice President of Development. The Sr. Director of CMC will work closely with cross-functional teams, executives, and outside collaborators to ensure all CMC activities are well aligned with Dermbiont's project timelines and budgets.
Key responsibilities:
Qualifications:
