EDWARD J.

OESTREICHER (203) 261-1985

Easton, CT 06612 edoestreicher@gmail.com

DIRECTOR, CLINICAL AND COMMERCIAL MANUFACTURING, SUPPLY CHAIN OPERATIONS Pharmaceutical, Biotech and Medical Device Products
Have developed and led multiple fully integrated manufacturing facilities and operations that promote growth and profitability. Considered an expert in transitioning products from R&D through pilot plant and commercial manufacturing in entrepreneurial startup companies and multinational enterprises. Strengths Analytical, hands on and results oriented with track record of achieving all goals Devising and implementing strategies, plans, systems and procedures to support rapid growth and change Maximizing productivity, profitability and quality while keeping costs well under control Outstanding record of meeting all quality and regulatory compliance requirements; FDA, EMA, ISO, OSHA, EPA Knowledgeable in CMC regulatory filings Personable, persuasive, trusted business advisor and savvy negotiator . Quick thinker, analyzes situations rapidly and simplifies complex problems. Intuitive decision-maker. Highly articulate, strong group communicator. Motivates and inspires others to top performance. Well respected leader, ability to get things done quickly and correctly.

Career History & Selected Achievements

Owner and Independent Consultant

Edward J Oestreicher LLC, (2010 Present) Company specializes in optimizing all types of pharmaceutical / biotech operations including facility management, startups, turnaround, process improvement, new product development, commercialization and global product launch.

Selected Accomplishments: Improved the quality processes for a Global Biotech company significantly addressing and reducing deviations and CAPAs, enabling batch releases, resulting in on time product supply of a seasonal vaccine avoiding a $20MM write-off Selected by a major consulting firm as Project Manager organizing and leading experts in remediation of operations to achieve full compliance to a Consent Decree for a major Consumer Health Corporation

Director of Manufacturing Operations

International Partnership for Microbicides (IPM), Bethlehem, Pennsylvania (2009-2010) (IPM a non profit company downsized in 2010 due to a major drop in donations, the Bethlehem site was closed) IPM is a research based company that partners with major pharmaceutical companies in developing medical devices containing anti-infectives for use by women to prevent HIV infection. Reported to the COO/CFO with an operating budget of $25MM. Led a team of 5 professionals and 50 hourly employees in; Process and Mechanical Engineering, Procurement, Manufacturing, Packaging, Materials Management / Supply Chain and Distribution as well as external CMOs and international logistic service providers. Supported multiple Phase I-III Clinical trails in the US, Europe and Africa.

Selected Accomplishments at IPM: Instituted bi weekly meetings with the executives of R&D, Medical / Clinical Trials and Legal to review new clinical trial protocols, and status of each existing clinical trial, ensuring transparency and on time / every time delivery to the clinics Oversaw the development of two new products from bench top, through scale-up and commercial size batches for clinical trials, ensuring process reliability, continuity and efficacy of the product. Personally reviewed and approved all equipment and process validation protocols, manufacturing batch records and laboratory testing / results, all labeling / translations, import documentation for supplying trial materials obtained approval of Medical and Legal executives prior to releasing for shipment to the clinics avoiding delays in customs, etc.. Obtained EMA approval of the facility, systems, protocols, procedures and processes with no adverse observations Avoided a $2.5M capital investment by transitioning large volume / late stage Phase III trials to a CMO in Europe

Director of Materials Management, Commercial Manufacturing

MannKind Corporation, Danbury, Connecticut (2008-2009)
(Firm downsized twice due to additional long term studies required by the FDA for the inhaled insulin and medical device)

MannKind is a publically traded startup pharmaceutical company specializing in development of inhaled insulin and corresponding medical devices. As the Head of Materials Management reporting to the VP of Commercial Manufacturing, with an operating budget of $40MM, 3 direct professional and 8 hourly employees in Materials and Inventory Management, Production Planning, Procedures / Systems, Warehousing and Distribution. Scope included a comprehensive cold chain program, product development, chemical, clinical and commercial manufacturing of drug product and devices across three sites.

Selected Accomplishments at MannKind: Defined the appropriate infrastructure including people, systems, facilities and equipment in alignment with needs reducing capital and expense spending by 24% and significantly improving operational performance Worked directly with R&D and Clinical Manufacturing in providing support for multiple scale-up test batches, and supply to various clinics in the US and Europe. Established policies and procedures, standards and metrics to minimize risk, flawlessly passing ISO 9000 and SOX audits; prepared the site for FDA approval while achieving 100% customer service

Director / Team Leader Pfizer Global Manufacturing

Pfizer, Inc., New York, New York (1995-2007) Pfizer, Inc is the worlds largest research based pharmaceutical company. Reported to and assisted the President of Global Manufacturing with responsibility for the organization and leadership of multiple cross functional teams and production sites globally. Direct reports ranged from 10-20 professionals.

Selected Accomplishments at Pfizer: Instituted co-development and mutual accountability between R&D, Clinical, Internal and CMO manufacturing of API and drug products facilities ensuring batch to batch continuity / quality Led multiple engineering / manufacturing project teams to complete facility expansions, renovations, HVAC system upgrades with controlled room pressure / temperature requirements, new equipment, and neutralization systems, as needed, scale-up, including validation, quality / environmental testing and production runs to ensure the on time launch of unique new products Formed and led cross- functional global project teams successfully launching 7 new biological and 5 pharmaceutical products on time and on budget and managing ongoing stability studies for API and drug products Developed internal and external sourcing strategies, performing due diligence of potential material and CMO suppliers. Negotiated and executed supply agreements. Re-negotiated several contracts saving over $50M Provided leadership and direction in leading manufacturing Process Improvement Teams improving process reliability, introducing new manufacturing technologies and initiatives, such as; Robotics, Right First Time and others Conducted annual budget and monthly cross-functional S&OP review meetings and planned the production strategy across multiple sites globally including new product development and manufacturing operations ensuring transparency in current production planning, scheduling and supply leading to 100% customer service levels Formulated and recommended manufacturing policies and capacity utilization, inventory and continuous improvement programs to improve product cost. All sites collectively reduced product costs from 2%-10% annually Resolved production and quality related issues for various in-line drug products ensuring product robustness and quality compliance

General Manager
Ohmeda Pharmaceutical Products, Guayama, Puerto Rico & Nottingham, England (1992 1995) Ohmeda Pharmaceutical, specializes in the development and sale of inhalant anesthetics world wide supplying over 70% of the global market. The Guayama, Puerto Rico site was the flagship and sole manufacturing location. Reported to the Senior VP Operations, directly led two facilities with 13 person management team and 348 total associates in all aspects of plant and supply chain management, engineering, maintenance, materials planning, logistics, quality, environmental/safety, regulatory compliance, HR and finance with operating expense budgets in the $40-60MM range. Selected Accomplishments at Ohmeda: Coordinated a $110 million capital program including pilot plant, construction, approvals and startup of a new API inhalant anesthetic manufacturing plant, packaging and warehouse / distribution facilities in Puerto Rico. Obtained FDA and EMEA approval on first inspection with on time launch of a new product. Took on additional responsibility in 1994 as General Manager of the Delta Biotechnology Group in Nottingham, England accountable for commercial scale up of recombinant serum albumin from yeast cells.

Plant Manager
Bausch & Lomb Pharmaceutical Division, Long Island, NY & Tampa, Florida (1989 1992) Bausch & Lomb Pharmaceuticals was a new division for B&L specializing in sterile ophthalmic pharmaceuticals. Reporting to the President, directly led three fully integrated manufacturing, packaging and warehouse / distribution facilities in New York with a workforce of 6 Department Managers and 440 colleagues with an operating budget of $20MM. Selected Accomplishments at Bausch& Lomb: Oversaw construction, equipping, staffing, process transfer, validation, regulatory approval and startup of a new $60 million sterile manufacturing / packaging, warehousing, distribution and executive office complex in launching a new division for B&L. Plant received FDA approval on first inspection. Transferred staff and all operations from New York to Tampa

Previous positions include:

Plant Production Manager, Beecham Laboratories (GlaxoSmithKline), New Jersey(1986-1989) Packaging Department Manager, Carter-Wallace, New Jersey (1984-1986) Technical Director and Plant Manager Trainee, Sterling Drug - New York & Mexico (1979-1984)

Education BA Biology / Minor Chemistry

Thomas More College, Ft. Mitchell, KY PhD program, Interdisciplinary in Engineering, Chemistry and Microbiology

University of Cincinnati, Cincinnati, Ohio Completed 45 credit hours toward PhD (MS Equivalent) Was unable to complete dissertation due to job offer from Sterling Drug, requiring relocation