Manufacturing Supervisor

Douglas John Stock

*******@*****.***

Education:

University of California, Davis

B.S. Biological Sciences, December 1993

Work Experience:

Genentech Inc. (May 1995 – April 2011)

-Senior Supervisor, Manufacturing – Rotational Assignment in the Mfg Initiatives Group (April 2010 – Present)

Support the CAPA process for investigation and inspection driven issues involving Manufacturing. Act as a CAPA Owner and collaborate with technical teams to determine appropriate remediation plans. Coordinate Manufacturing resources to ensure timely closure of CAPA action items. Assist in driving changes as a TrackWise Change Owner. Review documents and CERs to provide gap assessments.

-Senior Supervisor, Manufacturing (July 2007 – March 2010)

Responsible for supervision of up to 11 technicians, overseeing area operations for biochemical manufacture of CHO derived bulk products, ensuring operations are compliant with cGMPs and safety guidelines, and optimizing of manufacturing operations. Responsible for the development and training of the staff. Assist in support of department infrastructure and systems. Support of the hiring process for operations staff. Provide support of ongoing validation activities and other routine production. Assist in the preparation for regulatory inspections, support area tours, and present information when requested by inspectors.

-Bioprocess Supervisor (June 2001 – June 2007)

Responsible for the oversight of operations in the Small Volume Media Preparation department. Supervision of 3 to 4 bioprocess technicians. Provide coaching and career development opportunities for the staff through goal setting and performance reviews. Assist in preparation for regulatory inspections and insure ongoing compliance with cGMP and safety requirements. Participate in the creation, revision, and approval of controlled documents. Active team member in the transferring of a new product to our facility; including commissioning of the department, documentation and procedure readiness.

-Lead Bioprocess Technician (March 2001 - May 2001)

Responsible for the development and maintenance of the production schedule, cycle count, and special media productions for SVMP. Train colleagues on the existing protocols and procedures used in the lab and filling suite. Coordinate the daily work schedule of fellow technicians while considering non-production activities. Develop SVMP team by ensuring that all staff members are up to date on training requirements, oversee and support coworkers responsible for cross-training efforts, and identify ways to enable staff to develop independent skills within normal SVMP operations.

-Bioprocess Technician (May 1999 - February 2001)

Run and execute standard SVMP productions; support media hold studies for Manufacturing Sciences and large-scale operations as warranted. Interact with clients, and handle daily core duties in absence of supervisor. Identify, evaluate, and implement improvements with current procedures to enhance workflow, improve process, and reduce waste. Coordinate environmental monitoring of the SVMP lab areas. Tasks include compliance to safety requirements, cGMPs, SOPs, tickets, interfacing with business systems (POMs, BPCS, and DCS), and writing monthly lab summary reports. Inter-departmental tasks; 1) Compliance Process Team (VC3): providing updates on variance categorization, tracking, and giving feedback to the shift on data entry errors; 2) Man. Sci. group: HPLC analysis. Scope issues; ensure operational transitions during campaign changeovers, inspection readiness, and Pareto analysis of discrepancies.

-Lead Pharmaceutical Filling Technician (June 1996 - April 1999)

Responsible for coordinating and supervising shift activities with management to meet production demands. Reviewing documents for accuracy and completeness. Training other technicians and providing leadership. Authoring other technician’s yearly reviews and attending numerous courses in supervisory skills (e.g. Effective Communication, Seven Habits of Highly Effective People, and Conflict Resolution).

-Pharmaceutical Filling Technician (August 1995 - June 1996)

Responsible for receiving bulk products and processing of bulk products to final vialing. Proficient with all clinical manufacturing equipment, procedures, and processes. These included dilution, aseptic formulation, sterile filtration, lyophilization, and capping.

Cell Genesys (December 1994 - April 1995)

-Glassware Support: Responsible for the collection, cleaning, and autoclaving of glassware. Stocked shelves with supplies. Assisted in media preparation.

References:

Available upon request.

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