Senior Manager of External Commercial Biologics Quality Control
vor 2 Monaten
We are seeking a highly skilled Senior Manager of External Commercial Biologics Quality Control to join our team at Incyte. This role will be responsible for providing analytical support to commercial manufacturing performed externally at contract manufacturing organizations (CMOs). The successful candidate will work closely with the Director, External QC Commercial Biologics and will be actively engaged with collaborators/partners, CMOs, and interface with internal GBD, Supply Chain, Quality Assurance and Regulatory CMC groups to support product specifications, stability, investigations, analytical method transfer, validation, and annual product review.
Key Responsibilities- Manage and support the timely and effective completion of events, deviations, investigations, change controls and CAPAs. Incorporate risk management principles into the management and decision-making process, while promoting quality awareness and continuous improvement.
- Ensure QC framework processes and policies/standards are established, implemented, audited, and continuously improved to ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures.
- Review project plans, quality agreements, contracts, manufacturing documents, CMOs and Incyte CPV and APQR reports associated with external commercial manufacturing.
- Provide technical support for CMO and QC lab in Agency Inspectors' routine inspections.
- Ensure data quality produced by CMOs are maintained by performing data reviews per SOP requirements.
- Work with CMOs to complete lot disposition. Identify and resolve testing issues with service providers and CMOs. Provide analytical expertise and support for product investigations, improvements, etc. to ensure continued compliance with regulations.
- Provide analytical SME support in analytical technical transfer and reagent supply needs for REALM/ROW activities.
- Coordinate, set up testing plans and manage client testing for specific ad hoc testing required for stability and release.
- Monitor and manage stability testing programs to ensure compliance and reliability.
- Give support for ensuring successful tech transfer of validated methods from one partner/CMO to another as projects may require.
- Revise and approve analytical test methods that progress from development to the commercial arena.
- Provide data and input for CMC dossier preparation, submission efforts, and agency response to questions.
- Transfer and organize stability and release data, COAs, COTs, reports, investigations into Incyte quality management systems (LIMs, Veeva) and manage business share points with external/internal entities.
- Report out specified key performance indicators and communications, specific to quality and associated processes. Understand and propose improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
- Identify opportunities for continuous improvement of analytical methods or techniques and justify implementation plans to development teams.
- Effectively interact with other departments, quality groups (internal and external), bulk and finished product manufacturing, materials, supply chain, regularity affairs, finance, contracts and HR.
- Support the budget follow-up (PO request, Invoicing and Costs tracking).
- 5 years relevant experience with a Masters' degree or 10 years' experience with a Bachelor's degree.
- Knowledge in protein chemistry and large molecules is must.
- Extensive experience with analytical instrumentation and analytical drug product lifecycle.
- Statistical analysis skill.
- Operational Excellence / LEAN is a nice to have.
- Partner extensively within Biologics and Pharmaceutical Development, and with other Incyte functions, including Research, Regulatory CMC, QA, Tech Ops and Legal.
- Manage external collaborations through scientific and strategic understanding, and attention to program success, to maximize integration and synergy between Incyte and partner.
- Strong written and verbal communication and organization skills are required.
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Morges, Waadt, Schweiz Incyte VollzeitAbout the RoleWe are seeking a highly experienced Senior Manager, Quality Control External Commercial Biologics to join our team at Incyte. This is a critical role that will be responsible for ensuring the quality of our commercial biologics products manufactured externally.Key ResponsibilitiesManage and support the timely and effective completion of events,...
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Morges, Waadt, Schweiz Incyte VollzeitJob SummaryAs a Senior Manager of External Commercial Biologics Quality Control, you will be responsible for providing analytical support to commercial manufacturing performed externally at contract organizations. You will work closely with the Director, External QC Commercial Biologics, and be actively engaged with collaborators/partners, CMOs, and...
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Morges, Waadt, Schweiz Incyte VollzeitJob SummaryThis role is responsible for providing analytical support to commercial manufacturing performed externally at contract manufacturing organizations (CMOs). The Senior Manager of External Commercial Biologics Quality Control will work closely with the Director, External QC Commercial Biologics and will be actively engaged with...
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Morges, Waadt, Schweiz Incyte VollzeitJob SummaryThis role is responsible for providing analytical support to commercial manufacturing performed externally at contract manufacturing organizations (CMOs). The Senior Manager, Quality Control External Commercial Biologics will work closely with the Director, External QC Commercial Biologics and will be actively engaged with collaborators/partners,...
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Morges, Waadt, Schweiz Incyte VollzeitJob Summary We are seeking a highly skilled Senior Manager, Quality Control External Commercial Biologics to join our team at Incyte. This role will be responsible for providing analytical support to commercial manufacturing performed externally at contract organizations. The successful candidate will work closely with the Director, External QC Commercial...
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Morges, Waadt, Schweiz Incyte VollzeitJob Summary:This role is responsible for analytical support to commercial manufacturing performed externally at contract manufacturing organizations (CMOs). The position will work closely with the Director, External QC Commercial Biologics, and will be actively engaged with collaborators/partners, CMOs, and internal groups to support product specifications,...
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Morges, Waadt, Schweiz Incyte VollzeitJob SummaryThe Senior Manager Global Quality Compliance and Performance is a key member of the Global Quality team, responsible for ensuring the oversight of Incyte Quality compliance and driving quality performance across the organization.Key ResponsibilitiesDevelop and maintain a comprehensive GxP quality risk management system, ensuring compliance with...
