Dec 2006 – Jan 2009 · 2 yrs 1 mo · San Diego, CA

• Managed production of phase III clinical injectable products and acted as parenteral specialist in resolution of processing issues.
•  Tech support in production of pre-filled syringes at a contract manufacturing site in Germany. Responsibilities included resolution of technical issues at manufacturing site and being a “person in the plant”.
•  Took lead function in the manufacture of sterile powder in vials at a contract site. Worked successfully with various cross functional groups.
•  Lead a group of engineers and technical personnel in the design and fabrication of production equipment. Participated actively in the design and execution of equipment IQ/ OQ programs.

Oct 2004 – Oct 2006 · 2 yrs · Thousand Oaks, CA

• Managed and led a multi-disciplinary team to produce drug products to the Global Operations Teams (GOT) on time and of consistent quality at contract manufacturing organizations (CMO).
•  Acted as Lead Project Manager... In association with analytical and formulation scientists, quality, legal and finance, completed multiple projects from contract selection/initiation to shipping of released drug products on time for use in clinical trials or to the market.
•  Activities included: selection of CMO, initiation of CDA/contract, receiving and negotiating quotes, technology transfer (method validation, equipment specifications, formulation/ manufacturing process), procurement of raw materials, development of timelines, documentation, QA disposition, invoicing and shipment of released products.

Dec 2002 – Sep 2004 · 1 yr 9 mos · South San Francisco, CA

•  Managed manufacture of sterile products at contract manufacturing facilities. Interacted with various entities within organization such as QA, QC, and Regulatory to resolve problems as they arose in a pro-active fashion. Performed “Person in the Plant” duties supervising manufacturing activities.
•  Directed processing studies, wrote concise protocols/ reports and interacted extensively with contract laboratories in conducting processing experiments. Instrumental in cutting the lyophilization cycle time by 33% thus realizing thousands of dollars in savings.
•  Communicated effectively with people within the organization regarding projects and made thoughtful and intelligent presentations in meetings.

Feb 1998 – Nov 2002 · 4 yrs 9 mos · Fremont, California

•  Prepared validation protocols for various validation studies related to manufacturing processes. Oversaw validation studies and wrote concise validation reports.
•  Managed manufacturing operations ensuring compliance with cGMPS. Performed “Person in the Plant” duties supervising manufacturing activities at contract manufacturing plants. Resolved manufacturing issues in a prompt and satisfactory manner. Performed audit of completed manufacturing documents.
•  Facilitated the design of secondary packaging. Conducted packaging/shipping studies.
•  Through effective contract negotiations, saved more than a million dollars in manufacturing cost.

Aug 1981 – Dec 1995 · 14 yrs 4 mos · Palo Alto, CA

• Fifteen years experience manufacturing sterile products for pre-clinical and clinical studies working hands on in compounding, sterile filtration and aseptic filling of sterile liquid and lyophilized products. Supervised four operators in-house and had oversight responsibilities for manufacturing products in contract facilities. The facilities used included Pfizer, Wyeth, and Boehringer-Knoll. Wrote standard operating procedures for processes and equipment operation. Maintained SOPs and training records.
•  Participated in the selection of major equipment in the manufacturing facility such as steam sterilizer and a custom-designed large capacity ampule leak tester.
•  Critical team member with other functional groups, in auditing prospective contract manufacturers.
•  Demonstrated skill in core sterile product manufacture, consistently winning acclaim from Syntex internal groups and vendors for efficient management

Jan 1979 – Jul 1981 · 2 yrs 6 mos · Chatsworth, CA

• HPLC/ GLC method development, wet chemistry.