Biopharm Operations & Infrastructure Consulting
2010 to July 2011
INSTITUTE FOR HUMAN GENE THERAPY
Associate Director, Vector Production Laboratory
2000 to 2000
Associate Director, Biologic CMC Sciences
CMC Program Manager
Associate Director, Biologics CMC Sciences
September 2018 to March 2019
CMC Program Manager
July 2011 to January 2013
Associate Director, Biologics CMC Sciences
September 2018 to April 2019
Sr. Director, Project Management, Operational Planning & Logistics
March 2008 to November 2009
Sr. Director, Manufacturing
2003 to 2008
Director, Farm Operations
2000 to 2003
Sr. Director, Manufacturing
1994 to 2000
1993 to 1994
1992 to 1993
Group Leader, Pilot Scale Manufacture
1989 to 1992
Principal Research Scientist, Biochemical Process Development
1987 to 1989
Collaborative Research, Inc.
Senior Research Scientist
June 1984 to September 1987
What company does Wes Church work for?
Wes Church works for Biopharm Operations & Infrastructure Consulting
What is Wes Church's role at Biopharm Operations & Infrastructure Consulting?
Wes Church is Independant Consultant
What industry does Wes Church work in?
Wes Church works in the Biotechnology industry.
Independant Consultant @ Biopharm Operations & Infrastructure Consulting From 2010 to July 2011 (1 year) Associate Director, Vector Production Laboratory @ INSTITUTE FOR HUMAN GENE THERAPY • Transition gene therapy viral vector production efforts from academic research mode to fully cGMP compliant clinical trial material production operation. Responsible for all phases of vector production and quality control testing. Outsourced manufacturing operations when University closed facility. From 2000 to 2000 (less than a year) Retiree @ Home Associate Director, Biologic CMC Sciences @ AbbVie Worcester, MACMC Program Manager @ AbbVie Plan and manage all biologic drug substance activities relating to the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings. Work on proprietary, partnered, and contract manufacturing biopharmaceutical programs. Worcester, MAAssociate Director, Biologics CMC Sciences @ AbbVie From September 2018 to March 2019 (7 months) Worcester, MACMC Program Manager @ AbbVie From July 2011 to January 2013 (1 year 7 months) Worcester, MAAssociate Director, Biologics CMC Sciences @ AbbVie From September 2018 to April 2019 (8 months) Worcester, MASr. Director, Project Management, Operational Planning & Logistics @ GTC Biotherapeutics • Responsible for planning, budgeting, and managing clinical and commercial manufacturing activities for both proprietary and client biopharmaceuticals, from source material collection to fill/finish. Project budgets range from $10M - $30M.• Revised work breakdown structure and accounting codes, created detailed process maps and highly detailed Gantt templates, providing company with greater accuracy in project cost management. Trained both project management staff and operational departments on updated project cost management system, virtually eliminating need for monthly reclassification of labor and material costs and enabling more accurate cost accounting.• Established and led project involving Tech Ops, Manufacturing, and IT to create a manufacturing process database to facilitate establishment of product and process specifications for regulatory filings, and improve accessibility of process data for trending and monitoring purposes.• Managed Logistics (supply chain) and Purchasing departments. Purchasing routinely negotiated annual savings to company in excess of their salary. Logistics supported two very different operations sites (farm and laboratory/cGMP manufacturing), as well as offsite storage contractors. From March 2008 to November 2009 (1 year 9 months) Sr. Director, Manufacturing @ GTC Biotherapeutics • Generated, in collaboration with Quality and Regulatory department heads, operational philosophy for company, wrote regulatory submissions (INDs, BLAs, MAA), hosted regulatory authority inspections, and responded to follow up questions, all of which led to European and US approval of the world’s first transgenically sourced therapeutic protein, ATryn.• Managed various departments via six direct reports, including Pilot Operations, Tech Operations (tech transfer), Project Management and Operational Planning, Purchasing, Manufacturing Dairy Operations, Logistics, and Farm Operations.• Built, fit out, hired, and trained staff for farm site clarification facility, and headquarters site cGMP compliant purification facility. Facilities were used to successfully supply Phase I & II clinical material for multiple contract clients.• Spearheaded project to implement automated data collection for source material collection (goat milking), integrating Manufacturing Dairy Operations, Quality Control, Quality Assurance, and IT aspects in preparation for 2nd generation ATryn process. Project eliminated need for manual recording and transcription of milk collection data, provided automated interaction with QC database for ATryn concentration in collected milk, and met QA expectations for regulatory compliance. From 2003 to 2008 (5 years) Director, Farm Operations @ GTC Biotherapeutics • Managed six direct reports and 40+ indirect reports involved in farm activities, product production (source material collection), and logistics functions. Farm staff also supported transgenic founder production performed by R&D and Vet Services, running estrus synchrony programs, and surgery preparation and staging for non-transgenic animals.• Restructured and rescheduled farm staff work force, implemented management training and goal based hierarchy and promotional structure to transition the farm site from an agrarian mindset to an “upstream” pharmaceutical production facility. Results were elimination of communications problems, creation of time for training and corporate meetings, and establishment of a professional career path for employees.• Moved company from anniversary performance review schedule to annual review schedule to enable correlation of performance to annual raise/promotion schedule.• Established operational procedures and documentation for goat dairy parlor suitable for collection of source material for pharmaceutical manufacturing use. Procedures and documentation were sufficient for regulatory authority approval for commercialization. From 2000 to 2003 (3 years) Sr. Director, Manufacturing @ ENZON CORPORATION • Managed cGMP production of two FDA approved (one CDER and one CBER regulated) commercial biopharmaceuticals, from manufacture of bulk drug through labeling and packaging including coordination with contract filling company.• Hosted multiple FDA and European regulatory inspections, including one of the first Team Biologics inspections.• Managed cGMP production of clinical supplies for multiple IND products. • Managed technology transfer from Research to Manufacturing and QC groups for PEG-Intron, then scaled up production. Product was selected by Schering Plough as the successor to Intron A, managed the tech transfer to Schering’s manufacturing and QC divisions. Drug became a billion dollar seller which generated substantial revenue for Enzon through royalties.• Diagnosed and spearheaded resolution of raw material problem which threatened to cripple production of Oncaspar. Worked closely with FDA to maintain supply of drug to patients until issue resolved, including preparation of documentation for submission.• Designed new 6,000 sq. ft. clinical material manufacturing facility in collaboration with contract engineering firm. • Selected engineering firm, oversaw construction, and validated WFI system used for commercial product manufacture when prior system failed.• Selected to manage PEG-hemoglobin project, which involved selection and oversight of contract bovine herd management and red blood cell collection site, Hb extraction, purification, and pegylation process improvements that doubled yield, created a closed system that allowed aseptic filling of bags outside of a traditional filling suite.• Merged, cross-trained, and reduced clinical and commercial production staffs by ~30% to reduce operating costs as IND projects wound down.• Prepared and adhered to multimillion dollar annual budgets. From 1994 to 2000 (6 years) Director, Operations @ Theragen Corporation • Evaluated and selected facility for product development and manufacture working with commercial realtors.• Managed four independent extramural gene therapy research programs and chaired company’s Scientific Advisory Board.• Provided technical and regulatory assistance to supported research programs in connection with regulatory (IND) filings.• Participated with President/CEO in fund raising presentations (“road shows”), gaining knowledge of corporate financing mechanics.• Supported due diligence activities for merger with GenVec, Inc., resulting in acquisition of all Theragen owned technology by GenVec. From 1993 to 1994 (1 year) Manager, Manufacturing @ Cytogen Corporation • Managed all aspects of production of FDA approved commercial product (OncoScint) including CMO antibody production, internal conjugation and internal fill/finish, packaging, and warehousing.• Planned, scheduled, executed, and met 1992 and 1993 production plans based on sales forecasts.• Selected to lead FDA inspection readiness team, resulting in a highly successful post approval inspection (three 483 observations, two relating to Annual Report and advertising statements).• Spent a total of approximately three months spread over 1992 calendar year at contract antibody manufacturer in England as man-in-the-plant to ensure adequate supply commercial raw material. Established excellent rapport with CMO, and contributed to numerous procedural improvements that reduced deviation frequency. From 1992 to 1993 (1 year) Group Leader, Pilot Scale Manufacture @ Cytogen Corporation • Implemented first use of hard-sided isolator technology for the production (not testing) of a first in class in vivo diagnostic monoclonal antibody conjugate. Same technology also used in the production of therapeutic MAb conjugates. Implemented use of purchased buffers and disposable technology as well.• Established antibody purification process and facility for clinical grade in-house production of monoclonal antibodies, fragments, and conjugates (seven products concurrently).• Managed in-house antibody production (cell culture) operations, including scale-up, implementation, inventory control, and clinical supply production (1990 – 1991). From 1989 to 1992 (3 years) Principal Research Scientist, Biochemical Process Development @ Cytogen Corporation • Developed scalable, reproducible cGMP compliant processes for whole antibody and antibody fragment immunoconjugates in multigram quantities.• Collaborated with Research scientists to eliminate un-scaleable or regulatorily prohibitive processes from consideration. From 1987 to 1989 (2 years) Senior Research Scientist @ Collaborative Research, Inc. • Organized and directed cell culture group for scale up of prourokinase for clinical use under contract to Sandoz Pharmaceuticals.• Directed all cell culture and purification aspects of production of natural Interleukin-2 for clinical use under contract to Triton BioSciences.• Designed containment laboratory facilities for IL-2 production purposes at new company site; oversaw relocation of materials, equipment, and personnel to new facilities.• Learned and implemented GMP principles and documentation systems. From June 1984 to September 1987 (3 years 4 months)
Introversion (I), Intuition (N), Feeling (F), Judging (J)
2 year(s), 2 month(s)
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