Vice President of R&D (Research & Development)
Sterling Life Sciences - New York, NY

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1) Be responsible for management of new product development, manufacturing and QC methods support to the point of commercialization
2) Act as a key technical liaison for programs contracted to the company through its Contract Services Business
3) Build and maintain excellent relationships with external partners / suppliers, customers and the relevant regulatory agencies as an advocate of the company and its clients
4) Provide strategic oversight of planning and prioritization of drug development projects for the company and its clients
5) Provide organizational leadership within the development group including its human and technology resources
6) Manage development activities for both current and new products to strict commercialization schedules
7) Oversee technology transfer activities from the development group or from contract service clients to manufacturing
8) Provide key technical and strategic consultation for effective technical development required for the ongoing manufacturing requirements of legacy products
9) Manage resources to provide CMC related data / information packages required for regulatory submissions against strict schedules
10) Manage development and implementation of comprehensive manufacturing strategies for biologic and small molecule drug products (process chemistry, formulation development)
11) Manage outsourcing decisions for drug substance development or other technical resources required to supplement development activities
12) Represent company during domestic and international (EMEA/EU and ROW) regulatory authority audits or inspections
13) Contribute to corporate strategic development related to regulatory submissions
14) Review study reports, manufacturing process documentation, investigator brochures, clinical study protocols and clinical trial documentation for compliance with cGMPs, cGLPs and other appropriate regulations and guidelines
15) Interact with key scientific, clinical research, marketing and commercial personnel within and outside of the company to ensure timely and accurate regulatory compliance
16) Review proposed changes to regulated processes and products to aid technical implementation within the restrictions of regulatory policy

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceuticals industry is strongly preferred
4) Preference will be given to people who have recent experience in research & development management

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