Production Manager

Location
Burlingame, CA
Salary
Up to $150,000 per year + benefits
Posted
Apr 02, 2021
Required Education
Bachelors Degree
Position Type
Full time

Position:           Production Manager

Department:     Manufacturing

KindredBio is a veterinary, biopharmaceutical company dedicated to saving and improving the lives of companion animals.  Our mission is to bring the best science and medicine to our animal companions.

Position Summary:

This position will manage manufacturing operation in a GMP manufacturing facility in compliance with GMP requirement. They will ensure operational equipment used in manufacturing are properly maintained, calibrated and functional, and that manufacturing associates/operators are properly trained and competent to perform manufacturing operations according to GMP requirements.

Position Responsibilities:

  • Provide scientific and technical expertise for manufacturing of biologics (equipment and process).
  • Establish upstream and downstream manufacturing processes.
  • Technology transfer and scale up between process development, manufacturing and commercial manufacturing. To define new production platforms.
  • Evaluate new equipment for current and future manufacturing.
  • Generate SOPs, BPRs, and forms for use during manufacturing.
  • Serve as the technical representative during manufacturing and fill/finish operations.
  • Participate in technical troubleshooting of equipment or processes.
  • Write and review technical development reports, regulatory submissions, deviation reports, and investigation reports, if needed.
  • Technical review of batch records for lot release, as required.
  • Troubleshoot manufacturing unit operations such as cryo-banks storage and freezing/thawing, inoculum expansion and bioreactor manufacturing, harvest clarification, mixing, sterile filtration, column chromatography, TFF, virus filtration, filing and vial inspection.
  • Write technical risk assessments.
  • Champion performance standards for cGMP process compliance, production success rates, and product quality.

Requirements:

  • 5+ years of relevant experience in the biopharmaceutical industry with a BS or MS degree in chemical engineering, biochemistry, biology, chemistry, or another relevant scientific discipline. A Ph.D is a plus.
  • Possess an expertise with all aspects of biologics cGMP manufacturing (i.e. quality assurance, quality control, validation, supply chain, and manufacturing).
  • Broad background with bioloigcs process development and manufacturing for upstream and downstream.
  • Needs to be an effective communicator to perform cross-functional roles, to work with other departments, and to work with vendors.
  • Technical expertise in upstream and downstream process development and biological drug substance manufacturing.
  • Ability to implement new technologies.
  • Strong organizational skills.
  • Ability to interact effectively with senior management to provide resources and budget planning.
  • Excellent business attitude to establish and maintain a network of preferred vendors.
  • Establish proper business agreements with outside partners covering non-disclosure agreements, service terms and conditions, and contract pricing negotiations.
  • Excellent written and verbal communications skills