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Senior Manager Technical Operations

Posted on Oct 6, 2021 by Elevate Direct

Cork, Ireland
Immediate Start
Annual Salary
Senior Manager Technical Operations

The successful candidate will join the Small Molecule Active Pharmaceutical Ingredients (SM API) manufacturing site, located in Cork, Ireland.

The lead coordinates process engineering resources in support of product life cycle strategies, new product launches, technical transfers, new process technologies, cleaning validations, process and sterility validations, and overall performance tracking.

This position contributes to the global API SM TO strategies and the financial performance of the local production site in Cork. The lead is a team member of both the local site leadership team and the global TO leadership team and will report into the TO Director for API Small Molecules.

  • Direct a team of engineers taking ownership for new product introductions, Life Cycle Management (LCM) support and optimizations of production processes.
  • Deliver the technical operations service to meet the site business goals.
  • Works together with the other TO site leads to drive commonalities, share knowledge as to deliver value through improved collaboration.
  • Translate global strategies into G&O's for the local team.
  • Take accountability as a SPOC (single point of contact) for all TO activities at the site.
  • Take accountability for Process and Cleaning validation at the site in close collaboration with the global TO Subject Matter Authorities.
  • Works with the global technology development function to craft specific technology solutions for optimized synthesis processes.
  • Works globally to develop and implement data analytical tools.
  • Organize adequate support for CapEx projects.
  • Build a dynamic and empowered team, strong in collaboration and assuring flexibility across BU's.
  • Stimulates a One plant approach and culture to strengthen the overall value of clustering the business units.
  • Manage Product Transfers and Product Introductions.
  • Define the project Scope and Objectives collaborating with Technical Launch Integrators and Technical Owners.
  • Perform the Technical Assessment and Fit to Plant exercises.
  • Develop Project Strategies and Plan.
  • Develop the team and align with Technical Operations Global Functions, Quality Assurance, Development groups, Make Asset Management and Operations.
  • Process Transfer and documentation.
  • Provide engineering support during product life cycle.
  • Partner with Global Value Chain Lead and BUs on project priorities.
  • Partner with Production on Project Oversight of projects assigned as well as day to day support (eg investigations, critical issues).
  • Supervise process and product performance, based on Continuous Process Verification (CPV).
  • Lead or support complex process investigations supporting quality or compliance events.
  • Innovation & Standardization (Evaluate new technologies such as PAT; Contribute to Standardization initiatives for Technical Operations).
  • Support introduction of newer process technologies.
  • Implement Process optimizations and CIP's from improved data analytics.
  • Assure appropriate resource allocations to all the above deploying a standard resource model and training programs.
  • Identify growth opportunities for the team members and continue talent development for the local site and the global group.
  • Prepare Health Authority Inspections.
  • Technical support in partnership with Quality on any regulatory audits and inspections.
  • Being the Spokesperson in Audits internal and external for the TO processes.
  • Accountable for the applicable sections in the Site Validation Master plan.
  • The TO manager can also take the role of an API Technical Owner for a given synthesis or lead API Technical Owners in her/his team.

Have you?
  • A Bachelor's degree in chemical engineering or related field is required.
  • Strong people leader with previous experience in leading teams.
  • Proven experience of minimum 8 years in a pharmaceutical manufacturing environment
  • Strong expertise in Small Molecule API business
  • Strong experience in chemical manufacturing processes, technologies, and products
  • Project management, organizing, planning and coordination skills
  • Process excellence, lean production concepts and tools, JJPS
  • Strong mind-set and knowledge of Quality & Compliance/regulatory requirements (GMP/EH&S).
  • Aims for innovation and change towards improved performance
  • Strong interpersonal skills eg, influencing and handling conflicting interests
  • Demonstrated ability to build and maintain a diverse leadership team and champion an inclusive culture to realize the SM TO Vision and mission throughout the organization

This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent Full time opportunity and comes with excellent salary and full benefits package.

Reference: 1347450393

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