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Manufacturing Operations Technical Lead, CCP2

Company: F. Hoffmann-La Roche Gruppe
Location: Vacaville
Posted on: April 3, 2021

Job Description:

Manufacturing Operations Technical Lead, CCP2 This position is accountable to be the Manufacturing Technical Lead for large-scale capital projects as well as managing and ensuring alignment in prioritizing the Manufacturing project portfolio in both CCP1 and CCP2 The Manufacturing Operations Technical team lead is responsible for coordinating user requirements, execution of offline manufacturing review on the automated systems, coordinating validation studies, being the manufacturing project interface (ie: automation upgrade/capacity enhancements), enhancing the return to service (RTS) program and execution of RTS activities, and ensuring both plants are operationally ready for activities in compliance with GMP requirements for both the CCP1 and CCP2 facilities. In addition, the role is accountable for the strategic connection and continuity across all strategic projects in Manufacturing to enable successful project milestones. This role will be a representative for Manufacturing in Vacaville site User Teams for capital projects. This role will report into the head of CCP2 Manufacturing and be a member of the Manufacturing Leadership Team (MLT). Job Responsibilities Leadership & People Management:

  • Provide oversight, guidance, and direction to a cross-functional team that could include site staff in the areas of Safety, Manufacturing, Facilities & Engineering, MSAT, Materials Management, and Quality regarding project objectives, user requirements, deliverables and progress.
  • Establish, sustain, and leverage effective partnerships with network counterparts to share best practices and influence the effective management of Manufacturing related projects
  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term
  • Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • Establish unified connectivity between Manufacturing, asset management lifecycle, and investment portfolio, to ensure instruments, equipment and machinery are able to achieve long term objectives and obsolete equipment is replaced before failure.-- Technical:
    • Accountable for Manufacturing user requirements being incorporated into project design to fulfill site operational needs by gathering feedback and input from responsible parties
    • Develop goals and objectives in alignment with Project and Tech Transfer Teams.
    • Coordinate resolution of operational, equipment or process issues related to design, construction, commissioning, start-up or operation.--
    • Ensure project related changes do not negatively impact CCP1/CCP2 licensed projects.
    • Interact with Facilities & Engineering and MSAT on manufacturing process modifications required to enable production.
    • Prepare and present executive presentations and provide routine executive level communication regarding project status updates to Manufacturing leadership regarding; schedule progress, resource needs, budgetary updates, and escalation of relevant issues.
    • Coordinate, communicate & provide leadership for the various RTS / issue resolution sub-team leaders and help in routine and non-routine aspects for the cross-functional leaders as related to their functional area(s) work streams.
    • Accountable to develop, coordinate and manage the CCP1/CCP2 project portfolio including leadership of prioritization of those activities.
    • Close interaction with PTAA Project Manager (PM) and PTAA Team, Tech Transfer Lead (TTL), and Site Transfer Lead (STL), Project Management Excellence team on alignment and execution of required Manufacturing User Requirements.
    • Ensure that any projects that impact Manufacturing (product technical transfers, debottleneck projects, other) are aligned with Genentech/Roche standards, and comply with applicable internal and external Health Authority standards.
    • Provide leadership and oversight of CCP1/CCP2 systems startup, procedures and documentation development
    • Achieves operational objectives by contributing information and recommendations to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; resolving problems; completing audits; identifying trends; determining system improvements; implementing change.
    • Coordinate with functional groups on production, operations, quality assurance, testing, or maintenance requirements for Manufacturing.
    • Actively participate on the Manufacturing Leadership Team (MLT).
    • Report out project portfolio updates to Steering Committee monthly
    • Establish, sustain, and leverage effective partnerships with network counterparts to share best practices and influence the effective management of manufacturing related projects
    • Meets financial objectives by forecasting requirements; preparing budgets; scheduling expenditures; analyzing variances; initiating corrective actions.
    • Analyze project portfolio resource demand and coordinate with MLT to develop operational resource requirements--
    • Develop, review, approve, or modify Manufacturing project schedule while coordinating with the site IMPACT/PACE portfolio process.
    • Confer with upper levels of management to set direction with the required funding, resources, and schedules to meet required delivery dates.
    • Develop a sustainable process with the goal of real time release of batches. Job Requirements Education:
      • Bachelor's Degree (life sciences or engineering preferred)-- Experience (may vary depending on site size/scope)
        • 12 or more years' related professional experience or equivalent, ideally gained within the biotech or pharmaceutical industry (manufacturing, engineering, project and/or process management,).--
        • 8 or more years people management experience (includes experience leading direct and indirect reports)--
        • BA/BS in life sciences or engineering with minimum 14 years project management experience including; budget control, tracking, and forecasting; schedule oversight and management; scope definition and control; change review tracking and approval processes.
        • Understanding of large-scale cGMP manufacturing environments.
        • Knowledge of quality standards for manufacturing and change management at the site including thorough understanding of Good Manufacturing Practices (GMP's) as they apply to bioprocess manufacturing.
        • Ability to effectively communicate to all levels of the organization and across a broad cross-functional audience.
        • Strong understanding of and demonstrated experience with cGMP requirements for biologics manufacturing
        • Familiarity with the execution of capital projects and project accounting is preferred
        • Strong familiarity with biologics manufacturing process technologies. Experience with transfer and licensure of biologics process is preferred
        • Experience across a wide range of pharmaceutical operations is strongly preferred--
        • Has successfully led cross-functional teams--
        • Has effectively and efficiently developed and implemented departmental annual or longer-range strategies, plans and objectives; and successfully led staff members in achievement of goals and objectives--
        • Consistently presents strategic, complex and sometimes controversial information and decision points to senior management in a highly effective, efficient and fully successful manner--
        • Expert knowledge of cGMP relevant to the pharmaceutical industry
        • Expert knowledge with start-up and validation of pharmaceutical manufacturing facilities
        • Possesses strong verbal and written communication skills and the ability to influence at all levels.
        • Capable at building trustful and effective relationships
        • Able to think strategically and translate strategies into actionable plans
        • Takes responsibility, drives results, and achieves expected outcomes
        • Ability to effectively communicate to all levels of the organization and across a broad cross-functional audience This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

Keywords: F. Hoffmann-La Roche Gruppe, Vacaville , Manufacturing Operations Technical Lead, CCP2, IT / Software / Systems , Vacaville, California

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