Posted to MedZilla on 5/25/2017


ProClinical

United States, Manager/Senior Manager, Technical Operation SC_HC_11966-MZ


 
 

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. 

Job Responsibilities:

  • 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.

Role Requirements

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.

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 send your CV to Hannah Cihlar on [click here] or upload 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. 


Please visit our website at www.proclinical.com

 
 


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