Reporting to VP, External Biologics Manufacturing, this position will be responsible for analytical support to commercial manufacturing performed externally at contract manufacturers. This position 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. This role requires solid scientific knowledge of a variety of analytical methods, broad and relevant industrial experience, familiarity with ICH and other international guidance, as well as global regulatory requirements to support global filing strategy. Strong interpersonal and communication skills are required, as well as organization and project management.
Duties and 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).
Requirements
·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.
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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