Location: New York, NY
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The Scientist, CMC will support Axsome’s CMC, pharmaceutical development, clinical and commercial supplies efforts, and assist in the development of new product candidates. Interfaces with vendors and CMOs. The position reports to the Senior Director, CMC and will manage essential duties and responsibilities as independently as possible. Key interactions with the clinical operations, regulatory, and management teams.
- Participate as a key member of the CMC and development team.
- Interface with drug substance and drug product vendors and CMOs.
- Draft and review written documents for INDs, CTAs, MAAs, NDAs for CMC Module 3 as well as batch records, protocols, development reports, etc.
- Assemble and maintain product development information repository to allow efficient retrieval of development reports, batch records, specifications, and other relevant documentation.
- Manage vendors to perform the labeling, packaging, and distribution of investigational product.
- Oversee stability studies and database.
- Support technology transfer processes.
- Research and coordinate raw material vendors for successful development of product candidates.
- Identify and evaluate vendors and CMOs.
- Assist in site inspections and audits.
- Perform other work-related duties as assigned.
Technical Knowledge, Skills
- Solid knowledge of pharmaceutical dosage forms, scale-up, and manufacturing, including validation and commercial batches.
- Formulation experience desirable.
- Knowledge of chiral chemistry desirable.
- Solid knowledge and understanding of CMC and process development required.
- Solid knowledge of cGMP. Experience working in a cGMP environment preferred.
- Knowledge of analytical procedures related to drug substance and drug product methods.
- Understanding of FDA regulatory guidance, ICH guidelines and requirements of NDA and IND’s.
- Bachelor degree required. Preference to candidates with a scientific background (MS, PharmD, PhD, or similar).
- Minimum 5-7 years of relevant experience in a biotech/pharmaceutical company preferred. Preference to candidates with prior small company experience.
- Requires excellent verbal and written communication skills.
- Requires problem solving and good interpersonal skills.
- Requires exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities.
- Requires the ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently.
- Preference to energetic candidates with a desire to think “outside the box”.
- Must be able to work in the NYC office.
- Willingness to travel periodically as needed.