VP/ Head of Manufacturing CMC
Proclinical is currently recruiting for a VP/Head of Manufacturing with a clinical-stage biotechnology company located in New York, NY. Successful candidate will establish and oversee pharmaceutical development strategy and tactical implementation plans for phase-appropriate formulation and manufacturing deliverables.
- Serve as discipline head for CMC, responsible for building the internal CMC function and identifying and managing key external CMO partners.
- Work with Regulatory, QA and senior management to develop, refine and ensure compliance with GMP and relevant regulations in US and EU.
- Effectively manages multiple vendors.
- Maintains knowledge of current best manufacturing practices and regulatory guidances and regulations.
- Lead preparation/content development of FDA and international regulatory filings in collaboration with Regulatory and Quality and the EVP of R+D.
- Oversee all manufacturing operations, including review and approval of master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as scope of work (SOWs) with CMOs.
- Communicate effectively, build relationships and actively partner with other discipline heads and CMOs, vendors, analytic laboratories and consultants.
- Responsible for development and oversight of scale-up and analytical testing of drug substance (API) and drug product (DP) production for preclinical safety/clinical testing and commercialization.
Skills and Requirements:
- PhD or equivalent in Biochemistry, Protein Science, Chemical Engineering or related Life Science discipline, preferred. MS with extensive industry experience in manufacturing/CMC will be considered.
- 15+ years' experience in manufacturing in the biotech or pharmaceutical industry.
- Extensive experience with the development, optimization and scale-up of manufacturing processes for biologic therapeutics. Formulation development expertise highly desired. Experience with therapeutic proteins desired.
- End to end drug development and commercialization experience, with prior experience leading the CMC discipline thorough successful BLA or NDA submissions and approvals, product launch and commercial stage manufacturing and supply chain.
- Prior experience in managing multiple functions such as upstream/downstream process development, analytical & formulation development.
- Hands on experience in oversight and management of CMC activities at CMOs and partner facilities.
- Ability to set up supply chain strategy while being technically competent to collaborate internally and with outside vendors on multiple process development issues.
- Strong analytical and problem-solving skills, with ability to 'troubleshoot' in all areas of CMC.
- Solid understanding of FDA and EMA regulatory guidances/requirements as well as experience with authoring regulatory submissions. Demonstrated ability to represent the company at regulatory meetings.
- Thorough knowledge of GMP requirements, and basic familiarity with GLP/GCP.
- Experience in the implementation of GMP QMS, quality oversight/release requirements in US and EU, root cause analysis, and CAPA implementation. Continuous improvement and Six Sigma training and mindset are highly desirable.
- Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.
- Ability to think, plan, and influence strategically and diplomatically on the process development priorities across multiple projects is necessary.
- Leadership and management experience essential with proven ability to build a team, coach and motivate employees, set priorities, and effectively make decisions.
- Willingness to travel domestically and internationally as needed.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.