Sr Mfg Manager, Emerging Technologies

Company: Lonza Group ( Learn More )

General Information
US-NH-Portsmouth
N/A
Not Specified
Full-Time
Not Specified
None
True
False
Job Description

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 





Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.



Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 



Do you want to help us as we shape the future of this great organization?



Job Description Summary

The Senior Manager of Emerging Technology operations will lead a safe, controlled work environment in all areas of responsibility, ensuring that objectives & expectations to do so are communicated and understood by all staff and the means to do so are provided. Leads or supports the operational execution of all CT projects and supports all associated construction and technical transfer activity. Supports the development of strategic plans for the business in concert with other members of the CT project team and Head of Emerging Technology operations. Meets and presents to customers the technical capability available in Portsmouth to meet their needs as well as attending to all customer operational interactions.



Job Description

Lead the definition and execution of Operational Readiness Activity for the assigned project at LPO to include.

  • Set up of manufacturing procedures & collaboration with QA to develop & execute ET quality systems aligned with existing operations & finished dose requirements.
  • Build & establish the manufacturing team, plus support formation of the wider operational team.
  • Delivery of clinical & commercial material as required.
  • Development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM strategies.
  • Definition and execution of all activity in compliance with EHS requirements.
  • Provide oversight and support to the definition and execution of Technical Transfer activities for the assigned Project at LPO to include.

  • Operational input into material requirements, process execution & methods transfer.
  • Operational input into defining & executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.
  • Ensure timely delivery of milestones for the Technical Transfer.
  • Co-ordination with Portsmouth Mammalian Operations and customer technical team.
  • Support the design and construction phase of the assigned project at LPO to include.

  • Operational input into concept design, detailed design and project execution.
  • Capital project business case development, funding authorization and reporting.
  • Execution of construction activity in compliance with EHS requirements, assuring a safe work environment.
  • Delivery of timely qualification and maintenance readiness of the new operation.
  • Working closely with Portsmouth Mammalian Operations, Lonza Global Engineering, and customer technical team.
  • Support the Head of ET operations, project manager & director to ensure.

  • Creation and maintenance of an accurate master schedule.
  • Progression of proposals, SOWs and change orders.
  • Appropriate interaction with key external (customer) and internal stakeholders.
  • Support of the wider Emerging Technology network to include.

  • Preparation of operational models and costs to support the proposal process
  • Improvement, risk mitigation and development opportunities as appropriate.
  • As a member of the Extended Leadership Team - support the definition and execution of wider site performance and improvement objectives e.g. D2E, DMS and Cultural Improvement Programs.

    Minimum Required Skills & Qualifications -

    Education

    BS in related science field, MBA or equivalent preferred

    Experience

    o   Direct interaction with regulatory agencies

    o   Core involvement in Technical Transfer and project activity

    o   Leadership of organizational change, staff hiring and training

    o   Continuous Improvement activities

    o   Generation and optimization of batch documentation (EBR preferred)

  • Experience of biological manufacturing operations preferred, in particulars Fermentation and Purification processes.
  • Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred
  • Experience of automated and manual visual inspection systems preferred.
  • Knowledge

  • Experienced manager
  • Team based management
  • Cost Center management experience
  • Skills

  • Proven ability to lead an organization through sustained transformational performance. Excellent leadership skills a must. 
  • Qualities & Attitude

    A knowledgeable, determined and calm leader who coaches and manages to drive results, and builds a culture that fosters learning and growing all personnel.  Ability to engage, interact and develop good working relationships with customer and Lonza staff quickly is very important



    Responsibilities 



    Education

    Bachelors (Required)



    Work Experience

    Operations (Advanced)

    Certifications



    Skills



    Language(s)

    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.



    Lonza.  The place to Go, Stay and Grow.

    Job Requirements