Associate Director - Third Party Manufacturing Operations - Pharma

Role : Associate Director - Third Party Manufacturing Operations

Industry - Pharmaceuticals

Skills - Manufacturing, Project Management, product Development, Product Transfer

Job Type - Permanent

Description - An exciting opportunity with a global pharma giant to lead and manage all Third Party Operations, Validation and Process activities for products developed and manufactured at outside contract facilities.

Client Details :

Our client is a leading pharmaceutical giant with presence across the globe, leaders in APIs space. They are looking to hire a strong candidate to lead their manufacturing, science and technology vertical for third party operations.

Job Description :

- Drive product robustness for all products in area of responsibility.

- Lead and manage all TPO Validation and Process activities for products developed and manufactured at outside contract facilities.

- This includes, providing product stewardship by ensuring the performance of all products are monitored and maintained in a validated state, supporting root cause investigations by providing Technical intelligence to deviations, technical complaints, OOS & CAPAs.

- Identifying and executing continuous improvement opportunities, leading New Product Launch technical teams and leading technical activities related to transfers of Drug Product Manufacture and Packaging.

- Be familiar with statistical tools to analyze data.

- Provide technical leadership in the areas of formulation development and process optimization using pharmaceutical processes

Profile :

- Minimum Degree in Pharma, Science, Chemistry, or Chemical Engineering or equivalent work experience.

- 10+ years pharmaceutical manufacturing/validation/other related experience for US FDA approved sites as well as EU .

- Knowledge of all pertinent technical information related to an assigned product.

- Detailed knowledge of the operation, maintenance, and utility of all manufacturing and/or packaging equipment for assigned projects.

- Thorough familiarity with cGMPs, SOP's, relevant government regulations, and current industry standards.

Job Offer :

An opportunity to work with the leaders in the pharma space along with market leading compensation.

Contact - Nupur Mehta

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