Senior Manufacturing Coordinator

5 - 7 years experience  • 

Salary depends on experience
Posted on 05/09/18
5 - 7 years experience
Salary depends on experience
Posted on 05/09/18

Job Description

Catalent San Diego is hiring for a Senior Manufacturing Coordinator who will be responsible for project management and the cGMP manufacturing operations for Phase I and Phase II clinical trial productions.

The Role (daily responsibilities)

  • Write manufacturing batch records for the following types of cGMP productions: manual and automated encapsulation, tableting, coating, fluid bed granulation, roller compaction, liquid fill/banding, spray dry dispersions, and more.
  • Collaborate with Pharmaceutics personnel and client with co-managing of cGMP runs
  • Host clients on-site / lead client meetings
  • Responsible for clinical label specifications
  • Perform route cause analysis, address production issues and generate production deviations
  • Generate CAPAs
  • Revise SOPs / streamline production batch records
  • Facilitate manufacturing tech transfer meetings with Process Development
  • Understand the work flow in the production suites
  • Provide troubleshootingsupportin manufacturing suites
  • Review executed batch records
  • Address product related-complaints
  • Works on a project team
  • Provide batch record training for manufacturing Technicians
  • Works closely with Quality, Manufacturing and Process Development personnel
  • Provide functional job training for Associate Coordinators and Coordinators
  • Senior Manufacturing Coordinator may have supervisory responsibilities

The Candidate (requirements)

  • Bachelor’s degree, from an accredited university, in a scientific discipline and a minimum 3 years of relevant experience in Pharmaceutical or Medical Device industry
  • To qualify for a Senior Manufacturing Coordinator, candidates will have a minimum of 5 years of relevant experience and a Bachelor's degree.
  • Knowledge of a cGMP manufacturing environment
  • Highly motivated, self starter with excellent oral and written communication skills
  • Strong organizational skills and the ability to multi-task
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Potential for career growth within an expanding team
  • Defined career path and annual performance review and feedback process
  • Medical, Dental, Vision and 401k are all offered from Day One of employment
  • Generous paid time off (PTO) and holidays\

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