Director Manufacturing Technology

SUMMARY

The Director/Associate of the Manufacturing Technology department leads and manages the MT function supporting the Yverdon Bioplant, tasked with Biologics Manufacturing under cGMP regulations in a multi-product facility for clinical and commercial supply. Provides leadership, direction and oversight to the associated teams and is responsible to meet financial and quality performance goals. In addition, this position is accountable to manage new Process/Product introduction and Process Validation at the Bioplant and to provide scientific, technological support during feasibility, technical planning phase and process transfer.

The Director/Associate of MT is also responsible for supporting regulatory inspections and audits as necessary.

DUTIES AND RESPONSABILITIES

• Lead the MT positions involved in tech transfer and process validation.
  • Lead Stage 2 Process Validation starting with establishment of a Process Validation Master Plan
  • Lead Stage 3 Continued Process Verification, (CPV), through the use of appropriate statistical tools
• Plan, direct, and effectively manage work to meet quality, productivity and efficiency goals:
  • Ensure the safety of work practices in accordance with the safety program.
  • Ensure staff is sufficiently trained to perform their job responsibilities.
  • Develop strategies that ensure achievement of objectives that are consistent with Incyte’s strategic direction.
• In collaboration with Process Science ensure appropriate bill of materials and process descriptions are established per stage of development to enable batch record authoring.
• Establish and maintain an appropriate production and process model that supports COGs assessment as well as facility fit.
• Facilitiate technology transfer from internal development groups or external CMOs.
• Accountable for new process/product introduction. This includes providing facility fit assessment, technical evaluation of production data, scale-up, process validation, troubleshooting and support for regulatory filing activities.
• Author control strategy for commercial processes
• Support pFMEA as required for Process Sceince to conduct process characterization activities.
• Identify opportunities for yield improvements through analysis of Bioplant production data.
• Responsible for the MT annual budget and quarterly forecasting processes.
• Manage head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives
• Lead process change control at the site in collaboration with Process Science, Manufacturing, Quality Assurance, Quality Control, and CMC Regulatory Affairs
• Collaborate with plant management in resolution of any production problems, provides analytical trouble-shooting support to ensure effective corrective actions to root causes
• Support site readiness for regulatory inspections, including providing support for inspection preparation activities.
• Ensure key Quality metrics are maintained: such as training, investigation closure, and change control implementation
• Ensure close engagement with cross-functional counterparts and teams; serving as a key interface with Manufacturing, Process Science, Quality Assurance, Quality Control and Engineering & Maintenance, etc.
• Represent the MT operations during internal or external audits.
• Manage staff by setting objectives, creating development plans, providing individual mentoring and performance feedback/formal reviews.
• Provide process engineering input during design development, construction, testing, commissioning and qualification, including review and approval of appropriate design documents.
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Delegate to: Associate Director Process Science.

REQUIREMENTS

• Master Degree in relevant field such as Chemical Engineering, Biochemical Engineering, Bio-engineering, Biotechnology with minimum of ten years’ experience in Cell Culture and Protein Purification technologies; PhD Degree with eight years of direct experience will be considered.
• A minimum of six years leadership experience required with demonstrated ability to set vision and direction for a team, including setting expectations and motivating for results.
• Experience in leading tech transfer as a receiving site and process validation for Biologics required.
• Experience with Quality Systems such as Deviation, CAPA, Change Control Systems required.
• Experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment required.
• Demonstrated track record of success working on multiple new product introductions and technology transfer into a manufacturing organization.
• Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP practices; ability to force cross functional partnerships and strategies; ability to understand/evaluate business and organizational issues to develop and implement solutions.
• Leadership; ability to build trust and create collaborative environment and relationships.
• Ability to develop effective, flexible relationships with others; understands the business agendas and perspectives of others; recognizes and effectively balances the interest and needs within the organization.
• Must have experience leading the implementation of technical and business process improvements.
• Experience in the establishment of safe practices including expertise and knowledge in GMP engineering facilities and equipment design concepts in order to review engineering projects for compliance impact.
• Fluent in English and French.
• Available to travel.
• Excellent written and verbal skills.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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