cGMP Manufacturing Lead

Location
Pasadena, CA
Posted
Mar 19, 2018
Required Education
High School or equivalent
Position Type
Full time

As part of a talented and multi-disciplinary team advancing an exciting new approach to drug discovery, development and manufacturing, the successful candidate will be part of a small GMP Manufacturing team working to execute GMP production runs to supply the company’s clinical pipeline.  Other responsibilities include meeting with vendors to negotiate and procure equipment, leading and supporting IQ/OQ activities for facility and process equipment, creating SOPs and Batch records, establishing operational policies and procedures, and many other activities to ensure a successful production campaign.

Primary responsibilities include:

  • Perform GMP operations in Seed Lab, Cell Culture, Bioreactor Fermentation, Ultrafiltration, and Filling
  • Support clinical depot function including packaging and shipping of clinical vials
  • Work as part of a small team to execute GMP runs in close collaboration with Process Sciences
  • Transfer process from lab-scale to GMP-scale in support of Tox and early stage clinical studies
  • Inventory management
  • Media and buffer preparation
  • Equipment setup and maintenance
  • Gain understanding of Cell Culture and Bioreactor theories and principles
  • Successfully troubleshoot processing and equipment issues
  • Train new technicians

Requirements:

  • High school degree or higher
  • Experience in cGMP operations with minimum of 5 years experience; working with manufacturing equipment preferred
  • High degree of self-motivation is required
  • Ability to work under pressure and against tight timelines is required
  • Ability to work as part of a team and work independently with minimal supervision
  • Must have excellent interpersonal skills and exhibit a professional manner in dealing with others
  • Strong commitment to working safely
  • Ability to work off-shift and long hours as required
  • Mechanical aptitude, computer systems
  • Ability to lift 30 lbs is required
  • Ensures project deadlines and performance standards are met
  • Operates both independently and as a team member depending on current company priorities
  • Effective leadership skills and proven ability to foster team productivity
  • Qualified candidates must be legally qualified to work in the US.