A small growing pharmaceutical company is seeking a Manager/Senior Manager of Technical Operation to join them at their office in Bridgewater, New Jersey. The company is a specialty injectable pharma company that strives to develop innovative therapies to tackle unmet medical need in the world.
- Participate in the identification of CMOs appropriate for projects developed at the company, including due diligence site visits of prospective CMOs.
- Evaluation of CMO quotations for services and providing contractual input for company interests.
- Responsible for technology transfer from company R&D to CMO manufacturing, including scale-up and validation of products developed by the company R&D.
- Work with Program Management to assure alignment with overall project.
- Work with QA team to assure that manufacturing activities are in compliance with cGMP requirements.
- Maintain commercial relationship with CMOs and raw material suppliers.
- Ordering raw materials and componentry for registration and clinical trial manufacturing.
The candidate must be solution-oriented, operationally savvy, creative, highly organized, flexible, and adept at handling multiple projects with tight deadlines via multiple stakeholders.
- Experience in pharmaceutical IV drug development or commercialization of drug products in various platforms: Vials, bags, ophthalmic and Pre-filled Syringes.
- Knowledge of clinical development process and regulatory requirements for injectable 505(b) 2 advantageous. This will be a highly visible position interacting with many internal functional groups, as well as external vendors.
- A minimum of BS in Chemical Engineering, Physical or Analytical Science with 8 years of experience in pharmaceutical field.
- Preferred - MS in Chem. Engineering Physical or Analytical Science with 5 + years of experience in pharmaceutical Industry.
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A full job description is available on request.
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