Position HR037 – Technical Operation Manager/Sr. Manager
Location: Bridgewater, NJ
Nevakar is a specialty injectable bio-pharmaceutical development company, based in Bridgewater, New Jersey.
Products targeted for development by Nevakar are expected to address unmet clinical and commercial needs of currently available molecules, and thereby offer value proposition to patients, prescribers and payors. These products will be filed with FDA, primarily under 505(B)(2) regulatory pathway.
- Participate in the identification of CMOs appropriate for projects developed at Nevakar, including due diligence site visits of prospective CMOs.
- Evaluation of CMO quotations for services and providing contractual input for Nevakar interests.
- Responsible for technology transfer from Nevakar R&D to CMO manufacturing, including scale-up and validation of products developed by Nevakar 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.