Global Head of Commercial Laboratory Operations
- Celgene Corporation
- Date de publication
Global Head of Commercial Laboratory Operations
Position Global Head Commercial Laboratory Operations
Manager VP, Global Quality Operations
Prerequisites Bachelor's Degree in Pharmacy, Chemistry or Microbiology.15+ Years Laboratory Operations experience (Advanced Degree in Related Field an Advantage)
Location Neuchâtel, Switzerland
PURPOSE AND SCOPE OF POSITION:
The Global Head of Commercial Laboratory Operations is accountable for oversight of all commercial laboratory operations, including Celgene operated laboratories, as well as oversight of contracted commercial laboratories. This position will ensure Celgene laboratory operations comply with regulatory requirements and adopt effective and efficient industry standard practices.
DUTIES AND RESPONSIBILITIES
• Responsible for the Commercial Quality Control Laboratories (Inc. Microbiological labs) located at Boudry, Couvet and Phoenix.
• Directs all operational aspects of the Laboratories in support of Stability, raw material, in-process, finished product, environmental monitoring and investigative related testing functions.
• Participate in audits conducted by regulatory agency representatives.
• Responsible to set-up and oversee Marketed Product Stability Programs with associated track/trending capabilities to ensure timely alerts of any OOT/OOS test result
• Senior QC member of the Product Specification Committee.
• Accountable for selection qualification and on-going oversight of commercial contract service provider labs.
• Accountable for technical review of USP and Supplements, and the USP Pharmacopoeia Forums plus other compendia (EP, JP, BP) to ensure methodology and procedures are compliant with current standards.
• Oversee complex investigations / quality testing issues/deviation in order to analyze and propose corrective actions to prevent reoccurrence and work with QA for product disposition.
• Review and approve new and revised QC and Microbiology related SOP's to ensure global standardization and full compliance with cGMP's.
• Ensure strong change control business process in place for all Commercial specifications and methods.
• Identify best practices both internally and external, through comprehensive bench marking, define the implementation strategies and roll out through network.
• Accountable for developing/driving the roll-out of a sustainable global program to fully comply with QC data integrity requirements from all Health Authorities (e.g. FDA/MHRA etc.) through product development to commercialization.
• Accountable for driving the LIMS strategic initiative across the organization working in partnership with the Analytical function to maintain a fully compliant LIMS architecture from Development to Commercial Operations.
• Participate in production planning process, prepare budgets, recommend capital expenditures for technology and equipment (in close partnership with Analytical Development to ensure standardization), and allocate resources to support manufacturing, testing, and investigations.
• Work with Heads of Manufacturing to ensure full alignment of Commercial Product Testing schedules to comply with business needs.
• Accountable for managing the Development of Quality Control leaders/scientists to ensure a robust scientific leadership pipeline
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
• Must have strong communication skills. Must be able to communicate effectively to management, functional groups, broader organization, and executives.
• Must be skilled in strategic thinking, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and able to transmit strategy into secure execution.
• Multi-product commercial lab/network experiences both internal and contract Labs (including stability testing program responsibilities across multiple dosage form types.
• Electronic laboratory system implementation experience a plus.
• Requires an in-depth knowledge of quality control systems, including FDA and EU compliance standards, regulations, and guidelines.
• Requires experience with analytical development and validation in support of all stages of drug development from pre-clinical to marketed product;
• Experience working with both solid dose and sterile product test methods and specifications.
• Experience in leading a large multi-product commercial laboratory/network of laboratories.
• Development Laboratory experience would be a plus.
EDUCATION AND EXPERIENCE
• Requires a Bachelor's degree in Pharmacy, Chemistry, Microbiology or related science.
• Prefer an advanced (M.S., Ph.D.) degree in Pharmacy Chemistry, Microbiology or related science.