Night Manufacturing Manager - Vaccines/COVID Vaccine

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 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.

Key Responsibilities:

  • 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.

Key Requirements:

  • 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.

Reference: R36675