- Lead small molecule drug substance development and manufacturing operations to maintain and advance company pipeline.
- Manage and maintain project timelines for CMC activities in support of early and late-phase clinical trials.
- Manage in-house CMC personnel and external subject matter experts
- CDMO and other vendor identification, assessment, qualification, and management with adequate risk assessment.
- Manage tech transfer, process familiarization, and manufacturing at CDMOs to ensure timely delivery of GMP drug substance and drug product.
- Contract and Quality Agreement negotiation.
- Manage CDMO's synthesis of new drug substances.
- Develop and carry-out a QBD approach to identify CPPs in support of CQAs for efficacy and safety of drug substance.
- Author/review/approve the relevant CMC sections to enable global regulatory filings.
- Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.
- Manage developmental stage-appropriate analytical activities.
- Communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.
- Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to ensure CMC and program goals are met.
- Ph.D. (or equivalent) in Organic Chemistry, Chemistry, or a closely related field.
- 10+ years in industry CMC; 3+ years of experience as CMC team leader, managing team members and projects.
- A sound track record of technical expertise and organizational leadership, early and late stage CMC.
- Proven success in vendor management, specifically CDMOs, with track record of negotiating contracts and completion of projects on time and within budget.
- Successful management of CDMO to synthesize new API and to manufacture GMP product for late-phase clinical trials a plus.
- Thorough understanding and working experience in drug substance development and manufacturing with respect to quality by design, GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Experience writing CMC section of NDA is a plus.
- Experience with late stage drug substance is preferred.
- Familiar with medicinal chemistry and working knowledge of organic chemistry
- Working knowledge of drug substance analytical methods including phase-appropriate qualification/validation requirements.
- Basic understanding of drug product, including modified release solid oral dosage forms, including development and design principles is a plus
- Demonstrated strong project and cross-functional team leadership
- Ability to generate and maintain timelines through detailed Gantt charts.
- Strong problem-solving skills with strategic and sound technically driven decision-making ability.
- Excellent written and verbal communication, project planning, presentation skills and interpersonal skills are a must.
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Director CMC - Walnut Creek, CA, United States - Neurocentria, Inc.
Description
The CMC Director of Drug Substance Development and Manufacturing is primarily responsible for the development and manufacturing of small molecule drug substances in support of clinical development and commercialization of Neurocentria's pipeline compounds. The individual will provide technical and organizational leadership and work closely with cross-functional stakeholders to ensure CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines. The individual will lead the management of manufacturing of established drug substance for late-phase clinical trials and the development of new products. The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product.
Responsibilities
Qualifications
Company Summary
Neurocentria is a late-stage pharmaceutical company dedicated to discovering and developing novel treatments for neurodegenerative and neuropsychiatric disorders, including ADHD, depression and Alzheimer's disease. Since 2005, our team has been innovating breakthrough therapies to address the pathophysiology of these disorders, prevent their progression or even reverse their course, reduce symptoms and improve patients' performance and quality of life.
Our novel therapy, NRCT-101SR, is a small molecule modified release solid oral dosage. It is a new class of treatment for neurological disorders, developed to act on new molecular targets. NRCT-101SR is currently in late-phase clinical trials with two ongoing phase 3 clinical trials. With positive results, we are planning to file an NDA in 2025. We are also expanding our pipeline for treating neurological and neuropsychiatric disorders with multiple phase 2 clinical trials planned to start in 2024.
We are looking for an experienced CMC professional to join our motivated team. The CMC Director will primarily focus on manufacturing to support the late phase clinical trials and prepare to satisfy regulatory requirements for commercial manufacturing, and development of new products.
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