United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 current Good Manufacturing Practice (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 corrective and preventative action (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.
- Direct priorities through management team and deliver per production plan. Lead the department, managing safety, quality, current cGMP compliance and efficiency, product delivery, batch release, and financial execution.
- Deliver to Ready, Run, Release priorities per Plan. Independently able to make decisions and run the suites. Must reduce the variability of duration/time between runs related to equipment, process or document issues
- 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.
- Create and maintain a process-specific reference guide for troubleshooting, response, and escalation.
- Accountable for standard operating procedures (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 document management system (DMS) suite board actions/escalations as related to Equipment, Documents or Process
- Equipment and Process subject matter expert (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.) and 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.
- Actively provide coaching and mentoring to supervisors, associates by involving employees in issue identification and resolution.
- Perform other duties as identified.
- Significant working experience in manufacturing with prior leadership knowledge and/or supervisory experience; GMP experience and background within biotech highly preferred
- AS/BS; HS Diploma or equivalent may be considered with relevant experience
- Experience with 6S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred.
- In depth knowledge of pharmaceutical manufacturing, safe work environment leadership, and development of leadership teams delivering progressive continuous improvement in a multi-layered organization. Preferred knowledge of personalized medicine manufacturing.
- Demonstrates effective leadership
- Ability to work inter-departmentally and with customers.
- High level of suite specific operations and technical skills.
- Demonstrates role model behaviors for operating in a GMP manner.
- Demonstrates role model behaviors- e.g. 3 way communication, questioning attitude
- Demonstrates role model safety behaviors
- Strong written and verbal communication skills
- Demonstrate ability for effective Planning, Organizing and Controlling competency
- Demonstrate sound decision making, considering broad scope of factors
- This role requires the successful incumbent to successfully lead the organization through leaders who are direct reports. This role is required to inspire and compel excellence in performance from the leadership team, manufacturing team, and the broader Portsmouth Site’s organization through conspicuous and infectious energy and enthusiasm. Must be flexible to adapt to changing business priorities
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.