Director, Process Development and Manufacturing

Proclinical is currently recruiting for a Director of Process Development and Manufacturing for a clinical-stage pharmaceutical company located in New York, NY. Successful candidate will be responsible for the development and improvement of the downstream process of viral gene therapy vectors, as well as for the oversight of the tech transfer to and implementation at contract organizations.

Job Responsibilities:

• Development of downstream process strategies for viral gene therapy vectors.
• Identification and selection of contract development organizations for performing the development and improvements of downstream processes for viral gene therapy vectors.
• Responsibility for the execution of the downstream process development at contract laboratories.
• Oversight of technical transfer to contract manufacturing organizations, as well as proper implementation of the downstream process at the manufacturing site.
• Coordination with internal and external parties, including Program Management, Upstream Process Development, Manufacturing, Analytics and Supply chain.
• Identification and communication of risks in the downstream process and their mitigation.
• Responsibility to develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, or other controlled documents, as needed.
• Representation of the company as downstream process expert

Skills and Requirements:

• MS or equivalent in Chemistry, Biological Sciences, Engineering or related discipline, with 12+ years of experience; Ph.D. with 9+ years of experience preferred.
• Knowledge in interacting efficiently with Upstream Process Development, Analytics, and Quality Assurance.
• Expertise in early development as well as late stage/commercial pharmaceutical projects, preferably in gene therapy.
• Occasional travel to contract organizations required.
• Experience managing contract organizations.
• Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
• Results oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
• Accustomed "roll up their sleeves" and execute the tasks needed in a small company environment.
• Ability to set priorities, work independently and deliver results in a timely manner. Display a sense of urgency.

To Apply:

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 Matt Tong at (+1) 646-878-6308 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.

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