Vice President/Sr. Director/Director Resume
|Desired Industry: Biotech
|Desired Job Location: Boston, Massachusetts
||Date Posted: 9/11/2006
|Type of Position: Full-Time Permanent
||Availability Date: 09/15/06
||U.S. Work Authorization: Yes
|Job Level: Executive (President, VP, CEO)
||Willing to Travel: Yes, 25-50%
|Highest Degree Attained: MBA
||Willing to Relocate: Yes
Leadership position in the areas of Pharmaceutical Manufacturing, Operations and Supply Chain Management
PRAECIS PHARMACEUTICALS, INC.; Waltham, MA 4/1998 to Present
Biopharmaceutical company specializing in the discovery and development of novel compounds to address unmet medical needs or improve existing therapies; products include a commercial pharmaceutical product for prostate cancer (sold in the US and approved in Europe), a Phase 1 product for cancer and autoimmune disorder, and another Phase 1 product for Alzheimers disease.
Vice President, Industrial Operations (Manufacturing) & Development (6/2001 to Present)
Advanced to a senior-level role with responsibility for managing all chemistry, manufacturing and controls (CMC), manufacturing operations and supply chain functions for four of the companys products. Directly accountable for worldwide CMC (Pre-clinical, Phase 1-3, post NDA/European MAA approval) activities, including the development of product specifications, formulations, analytical methods, ICH stability studies, container/closure designs and production processes for products in aseptic, solid dose and cream forms. Manage all worldwide IND/NDA and European MAA CMC section filings.
Manage all domestic and international manufacturing at 14 contract manufacturing sites (API, drug product, final labeling and packaging), including supply chain/distribution activities. Responsible for all manufacturing contract negotiations, worldwide product demand forecast, production planning and plant capacity initiatives. Manage annual budgets averaging $20 million with an average headcount of 20 of which 6 are Ph.D.; hold P&L responsibility. Accomplishments:
Managed Drug Substance/Product CMC activities including formulation, conducting ICH stability studies, container/closure and final package design and analytical method development/validation that enabled the successful approval of NDA and MAA.
Led the IQ/OQ/PQ validation and scale-up at four manufacturing sites and successfully managed the FDA pre-approval inspections of these sites.
Supervised the development of two new drug substance processes and four new drug product formulations and completed the CMC section for four INDs in the last five years.
Led the production launch for a drug with new mechanism of action using a new drug delivery technology.
Increased commercial product manufacturing yield from 70% to 90%; manufacturing lot acceptance rate is 97.2%.
Senior Director, Industrial Operations (1/2000 to 6/2001) / Director, Industrial Operations (4/1998 to 12/1999)
Hired to build a commercial manufacturing supply chain infrastructure through establishing 14 contract manufacturing sites (API, drug product, final labeling and packaging) and a central distribution site. Position involved managing all manufacturing contract negotiations, worldwide product demand forecast, supply chain, plant capacity, and COGS activities, with focus on identifying COGS reduction and continuous improvement opportunities. Managed four direct reports and manufacturing budgets averaging $8 million. Accomplishments:
Reduced commercial product COGS by 60% by renegotiating favorable contracts and driving process/yield improvements.
Enabled timely Corporate NDA filing by implementing/validating all manufacturing processes at all sites in less than 24 months.
Supervised plant expansion design, met with FDA to seek guidance for design concepts and plans, and completed construction at four GMP sites in less than 18 months. Capital investments were more than $40 million.
HEOW M. TAN Page Two / firstname.lastname@example.org
Collaborated with four corporate partners to timely inform/coordinate CMC, manufacturing changes, and worldwide filing activities.
Transferred laboratory manufacturing processes/analytical methods to GMP manufacturing sites, and supervised process scale-up and analytical method validations. Led FDA and corporate partner quality inspection for each site.
SCICLONE PHARMACEUTICALS, INC.; San Mateo, CA 6/1993 to 4/1998
Director, Manufacturing Operations (6/1993 to 4/1998)
Appointed to direct all clinical and commercial product manufacturing, development functions (CMC) and supply chain activities for two of the companys products. Managed an annual budget averaging $3 million. Accomplishments:
Managed the product development activities (formulation, analytical method, ICH stability studies and manufacturing process development for aseptic and solid dose formulations), designed and prepared component specifications, planned and managed production at four domestic and four international sites.
Enabled timely launch of the GMP drug product by effectively managing manufacturing process transfer and scale-up in six months.
Reduced COGS by 35% through handling favorable negotiations with contract manufacturers.
Developed and established an international product supply chain network for 12 countries within two years.
SYNTEX LABORATORIES; Palo Alto, CA 6/1986 to 6/1993
$2 billion established pharmaceutical/animal health company (bought by Roche Holding) providing pharmaceutical products for diseases (ranging from life-threatening to improving quality of life medications) and products for improving animal health and instruments/devices to diagnose diseases or discomforts; company also conducted worldwide clinical trials for diseases for its pipeline.
Manager, Manufacturing Engineering (6/1992 to 6/1993)
Managed a cross-functional team of mechanical, chemical, industrial, and CAD engineering personnel in supporting product lines valued at $280 million. Managed an $11.6 million capital equipment and facilities budget. Accomplishments:
Investigated and evaluated new technologies and equipment for pharmaceutical processing and packaging.
Led development of instrumentation, automation, and material handling systems, and analyzed/managed plant capacity, product cost and contingency planning.
Improved staff morale by providing coaching and feedback, which resulted in an increase in promotions, improved reviews, and a turnover rate of less than 8%.
Manager, Production Scheduling (7/1988 to 6/1992)
Managed Syntex commercial supply chain activities with raw materials/product supplies for over 50 finished products (in more than 140 presentations) using more than 1200 components and raw materials. Supply chain infrastructure consisted of 5 in-house manufacturing plants and 9 subcontractors in 10 locations. Developed shipping policies, negotiated pricing with subcontractors, determined product quantity, managed overhead absorption and production cost variances, and assisted in planning/engineering of a sterile production expansion; utilized BPCS MRPII System. Co-managed $4 million material/warehousing budget. Accomplishments:
Spearheaded four new major production launches in new technologies valued at over $85 million at launch.
Negotiated and managed product subcontracting worth $50+ million annually.
Group Leader/Senior Manufacturing Engineer (6/1986 to 7/1988)
Responsible for designing and coordinating facilities construction and equipment installation, including long and short-term plans for capital investments with financial justifications. Managed an annual $6 million capital/expense budget.
MBA Finance Santa Clara University, Santa Clara, CA
MS Manufacturing Engineering The Ohio State University, Columbus, Ohio
BS Industrial/Systems Engineering The Ohio State University, Columbus, Ohio
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