What are the responsibilities and job description for the Director/Sr Director, CMC Development and Manufacturing position at Neurocentria, Inc.?
Director / Sr Director, CMC Development and Manufacturing
This range is provided by Neurocentria, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
205,000.00 / yr - $265,000.00 / yr
Additional compensation types
Annual Bonus and Stock options
The Director / Sr. Director of CMC 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 substances for late-phase clinical trials and the development of new products. The individual will also collaborate with the CMC team for the development and manufacturing of drug products, particularly for CDMO management; contribute to the overall CMC strategy, planning, and execution; and provide regulatory documentation for all phases of clinical trials and commercialization.
Responsibilities
- Lead small molecule drug substance process development and manufacturing operations to maintain and advance company pipeline, including early phase process development and late-stage GMP manufacturing.
- Collaborate with other CMC team members for drug product development and manufacturing.
- Manage and maintain project timelines for CMC activities in support of early and late-phase clinical trials, ensuring strategy and roadmaps align with and feed into company goals and project timelines.
- 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.
- 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 development reports and manufacturing batch records.
- 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.
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 2026. We are also expanding our pipeline for treating neurological and neuropsychiatric disorders with multiple phase 2 clinical trials planned to start in 2025.
We are looking for an experienced CMC professional to join our motivated team. The CMC Director / Sr Director will primarily focus on manufacturing to support the late phase clinical trials, preparing for commercial manufacturing regulatory requirements, and developing new products.
Seniority level
Director
Employment type
Full-time
J-18808-Ljbffr
Salary : $205,000 - $265,000