Technical Operation Manager/Sr. Manager


Job ID 17-00174

Industry Pharma

Job Type Permanent

Location Bridgewater, NJ

Description

Work for our start up client with tremendous growth potential! This company is developing very innovative and competitive products and is looking for highly capable individuals to join their team. This company has ambitious growth plans with its unique products as a fully integrated specialty pharmaceutical company.
 

Position Summary:
The Technical Operation Manager/Sr. Manager 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.  
 

Responsibilities: 
Participate in the identification of CMOs appropriate for projects developed at 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 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. 



Qualifications

Qualifications:
Preferred – Master's in Chem. Engineering, Physical or Analytical Science with 5 + years of experience in pharmaceutical Industry
  or
A minimum of Bachelor's in Chemical Engineering, Physical or Analytical Science with 8 years of experience in pharmaceutical field.