Christopher Bork Email & Phone Number

Oceanside, Ca, Us

South San Francisco, California, Us

Accountable for the overall technical leadership of Actemra (tocilizumab) and Avastin (bevacizumab) across the entire Roche/Genentech Drug Substance/Drug Product Biologics manufacturing network.• Provide strategic outlook and technical oversight of the manufacturing process to ensure optimal performance and process and product knowledge across the network. • Support the introduction of new process versions and technical transfers to manufacturing sites.• Ensure manufacturing consistency across the network.• Technical lead for product-impacting quality investigations (including process risk mitigation), product regulatory filings, and product approval inspections. • Collaborate with leaders from other commercial products to continuously improve life cycle management strategies, processes, and tools.

South San Francisco, California, Us

Managed a group of five associates responsible for providing technical process support to commercial recovery operations.• Motivated and supported the career development and technical expertise of staff.• Technical Team leader for overall Actemra process introduction to Oceanside. • Led the technology transfer for Rituxan® and Raptiva recovery processes and all associated process validation activities. • Provided technical guidance toward investigation of operational and process discrepancies. • Championed the implementation of several new technologies designed to improve process robustness and control.

South San Francisco, California, Us

Provided technical leadership and support in the transfer of the Avastin™ recovery process to the Oceanside, CA facility. • Designed and executed key experiments to characterize processing parameters for a continuous-flow centrifugation harvest process. • Authored process validation reports and assisted in preparing CMC section of sBLA. • Defended validation data during regulatory inspections leading to successful licensure of facility.

Cambridge, Ma, Us

Managed a group of five associates responsible for the technology transfer of multiple clinical products at two manufacturing facilities (2K bioreactor scale). • Assisted in the preparation and review of batch documentation. • Provided on-the-floor support during each campaign and oversaw all statistical process monitoring activities. • Coordinated the purification scale-up, optimization, and process consolidation of seven monoclonal antibody products (including the production of pre-clinical material for animal toxicology studies).

Cambridge, Ma, Us

Developed and optimized the purification processes for monoclonal antibody products and antibody drug conjugates.• Designed and executed experiments to chromatography resin lifetime validations critical for the licensure of Rituxan®. • Responsible for the technology transfer and production start-up of Zevalin™ at a contract manufacturer. • Contributing author of the CMC section of Zevalin™ BLA.• Provided technical expertise to FDA personnel during Zevalin™ PAI. • Played a key role in the development and optimization of purification processes for three other monoclonal antibody products.

St. Louis, Mo, Us

Supervised the large scale production of polyclonal antibodies, immunoaffinity resins, antibody conjugates, and growth factors. Assisted marketing and sales groups in the strategic implementation of corporate goals.

M.B.A., Management

B.S., Microbiology