Position: Production Manager
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.
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.
- 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.
- 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