| 1984 – Jan 2011 |
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Director, Quality Technical Systems, (2007-Jan 2011) Biogen Idec, Inc., Cambridge, MA & Research Triangle Park, NC
Provided strategic direction for IT systems used to support quality business processes (LIMS, document management, exceptions/CAPA management, change control, inventory control, product complaints and training). Led GxP compliance for all company computerized systems. Evaluated new analytical technologies and optimized analytical methods in support of QC laboratories.
- Developed 3-5 year strategic technology roadmap, created project management function and centralized capital management ($5 M/yr) for the Quality organization.
- Established quality system around process development activities including Quality by Design (QbD), Process Analytical Technologies (PAT), and process trending.
- Built first-in-kind product regulatory compliance verification system linking regulatory submission, change control and inventory management systems.
- Designed and implemented global QA electronic vital records program
Director, QA Validation (2005–2007)
Developed and implemented a corporate validation program covering facilities/equipment, automation, computerized systems, laboratory instruments, process, analytical methods, shipping and cleaning validation.
- Provided corporate quality oversight to the IT and Automation functions.
- Partnered with IT and Automation functions to develop robust global change control, validation practices and guidance documents.
Manufacturing Technology Principal, Global Engineering (2001–2005)
Provided process engineering and manufacturing expertise in support of manufacturing facility modifications, optimization and new facility design.
- Led process engineering design of Aseptic Fill/Finish and 15,000 L cell culture facilities constructed in Hillerod, Denmark including expatriate assignment with Jacobs Engineering in London UK (>$500 M project).
- Oversaw process engineering design for new Aseptic Fill/Finish facility used to manufacture clinical and commercial products.
- Optimized plant throughput for RTP, NC 15,000 L cell culture facility for new commercial product.
- Led technology transfer for 15,000 L scale process from RTP, NC to Oceanside, CA facility after Biogen merger with Idec.
Associate Director, Large Scale Manufacturing (2000 – 2001)
Coordinated and provided customer input for the design, startup, commissioning and validation of a 15,000 L scale mammalian cell culture and purification facility in Research Triangle Park, NC ($200 M project) and subsequent Purification expansion ($50 M).
- Reviewed and approved all design deliverables.
- Planned personnel, raw material and small equipment requirements.
- Coordinated initial process technology transfer activities for the site.
Associate Director, Manufacturing (1996 – 2000)
Directed start-up manufacturing operations at a 2,000 liter scale mammalian cell culture plant in RTP, NC. Recruited and managed staff of 60 people including cell culture, purification, technical support, warehousing, materials planning and procurement, process engineering, and validation functions.
- Oversaw startup, validation and operation of all manufacturing areas.
- Represented manufacturing in plant design, engineering, construction and commissioning.
- Effectively represented Manufacturing in numerous regulatory inspections.
- Plant achieved FDA licensure in 33 months from the date of groundbreaking.
Senior Manager, Manufacturing (1994 – 1996)
Managed cell culture and purification biopharmaceutical manufacturing operations (Cambridge, MA) including a staff of 40 supervisors, engineers and operators.
- Championed and managed significant cGMP plant improvements in preparation for plant commercial licensure.
- Interfaced with FDA and EMEA in pre-approval inspections for Avonex, Biogen’s first commercial product.
Manager, Bioprocessing (1990 – 1994)
Managed bioprocess clinical manufacturing operations including bacterial fermentation, mammalian cell culture and associated support areas and staff.
Other Past Positions (1984 - 1990)
Senior Supervisor, Purification, Senior Process Associate and Pilot Plant Supervisor
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