Senior Manager Regulatory CMC

Proclinical is seeking a Senior Manager Regulatory CMC for a cutting-edge pharmaceutical company located in New York.

This position reports to the Director, CMC and will manage essential duties and responsibilities as independently as possible. Key interactions may include the supply chain, regulatory, quality and management teams.

Must be eligible to work in the US.

Job Responsibilities:

• Participate as a key member of the CMC and development team
• Support clinical through late-stage drug product development and manufacturing activities for the company's product candidates, including clinical supply, registration and validation manufacturing
• Support technology transfer processes for drug product
• Interface with drug substance and drug product vendors and CDMOs
• Review batch records, tech transfer reports, campaign summaries and other related CMC documents
• Work closely with the CMC project team to develop and implement process development plans; manage process development activities and document information and data in appropriate format (reports, spreadsheets, etc.)
• Proactively monitor manufacturing processes and identify areas for process improvement and optimization; work with internal and external CMC teams to find solutions
• Assist with preparation of written documents for regulatory submissions (e.g. INDs, CTAs, MAAs, NDAs for CMC Module 3)
• Identify and evaluate vendors and CDMOs as needed

Skills and Requirements:

• Bachelors degree, Masters degree or PhD relevant experience in a biotech/pharmaceutical company
• Preference to candidates with a strong scientific background (i.e. chemistry, pharmaceutical sciences, polymer science, engineering, formulation development)
• Preference to candidates with prior start-up experience
• Ability to work on-site Monday, Tuesday, and Thursday
• Solid knowledge and understanding of CMC, formulation, process development, scale-up, and manufacturing of pharmaceutical oral dosage forms required
• Hands-on experience in research and development and/or scale-up and manufacturing required
• Manufacturing experience (registration, validation and/or technical transfer) of solid oral dosage forms is required
• Experience in project management and interaction with CDMOs required
• Solid knowledge of cGMP. Experience working in a cGMP environment required
• Knowledge and/or familiarity of analytical procedures related drug product methods
• Understanding of FDA regulatory guidance, ICH guidelines and requirements of NDA and IND's
• Experience with preparation and review of INDs, NDAs, other regulatory documentation and submissions preferred
• Problem solving and good interpersonal skills
• Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities
• Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently
• Willingness to travel periodically domestic/international as needed.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) 617-963-0342 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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