Manufacturing Manager (Cell & Gene Therapy)

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Manufacturing Manager is responsible for managing the overall production readiness, execution, and batch delivery for the production of therapeutic proteins (API) under cGMP conditions in upstream and downstream production areas. Manufacturing Managers will provide an immediate response to issues during manufacturing batch production. Managers will be responsible for leading cross-functional teams and customers to determine a clear understanding of problems and solutions. The Manufacturing Manager is the technical point of contact for support group questions regarding production execution, and owner of the equipment in the suite, including change control assessments for equipment modifications or new equipment, owner/approver of manufacturing relevant deviations and CAPAs ownership. Managers review/approve automation updates, validation, and maintenance protocols and the primary point of contact for these changes. Manufacturing Managers manage suite readiness planners and expert trainers and provide coaching/mentoring to manufacturing supervisors and associates.

Responsible for attracting and retaining skilled talent; training and encouraging a team-centric environment that improves business performance. Must be capable of motivating others, creating a positive work climate where inter-departmental collaboration, coaching and performance feedback are continuous. Capable of clearly assigning objectives, clearly setting and measuring and monitoring progress, marshaling resources and handling competing priorities. Experienced at establishing clear directions, leading others and bringing out their best.

Key Accountabilities:

  • Lead 2 total manufacturing teams (one day shift and one night shift). Direct Ready, Run, Release priorities through management team and deliver per production plan. Managing safety, quality, cGMP compliance and efficiency, product delivery, batch release, and financial execution.

  • Proficient in Root Cause Analysis / Cause Mapping to ensure effective proactive identification to prevent issues or problem resolution from eliminating the recurrence of the problems Identification and implementation of preventative actions in response to safety near misses or incidents Equipment Cost Center Review for all areas of responsibility. Runs major investigations and develops Storyboards as needed, e.g., contamination, etc. 

  • Process Management. Create and maintain a process-specific reference guide for troubleshooting, response, and escalation. Accountable for SOP clarity, accuracy, and relevance. Responsible for organizing SOPs for most efficient & effective ownership by supervisors and operators. Ensure owners have the expertise required to own the SOPs. Follow up on DMS suite board actions/escalations as related to Equipment, Documents or Process

  • Participate in manufacturing strategy decisions as a part of the manufacturing leadership team for Portsmouth. Lead cross-functionally with management, support departments, and customers to achieve site vision and strategy, meet business KPIs.

  • Equipment and Process SME: Identify non-routine technical training associates may need, develop material via T&D or Expert trainer, or supervisors/associates. SME for analytical instruments; e.g., FIT, NOVA, SoloVPE, Density Meters, Vicell, etc. Develop associate SMEs for these technologies. Conduct Post Campaign MFG Lessons Learned, which includes eDCF Review w MSAT (Face to Face).

  • Addresses Regulatory and Customer Audit Requests and any observation responses for Documents, Equipment, and Process. Participate in inspections as Backroom Triage Manufacturing Representative.

  • Ensure that the department is in a continuous state of readiness for production and GMP audits.

  • Supervise, train and mentor the manufacturing supervisors and direct reporting teams. Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.

Required:

  • AS/BS in Biotechnology, Biology, Chemistry, or related STEM field is preferred. High School Diploma or GED can be considered with relevant and satisfactory professional experience in pharmaceutical/biotech/life science manufacturing.

  • 5+ years experience in Leadership/supervisory/management roles in pharmaceutical manufacturing or similar field. Preferred experience in aseptic processing or biologic bulk drug substance delivery.

Preferred

  • Experience with 6S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R45784