Process Development Chemical Engineering, Director Engineering and Fac

Joseph Robert Tunner, Ph.D.

Encinitas, CA ***** Cell: 858-***-****

www.linkedin.com/in/joseph-tunner ***********@*****.*** PROFILE: Pharmaceutical Technical Leader directing large departments and small teams of Process Engineers, Facilities Engineers, Manufacturing Engineers, Validation Engineers, Manufacturing Teams, Technicians, and Scientists using my unique mix of management and engineering skills to successfully advance the development, approval, and commercial manufacturing of Drug Products and the Equipment and Facilities used to manufacture them.

COLLEGE EDUCATION:

Stanford University Ph.D., Chemical Engineering

Stanford, CA M.S., Chemical Engineering

University of Colorado B.S., Chemical Engineering

Boulder, CO Graduated with Special Honors, 4.00 GPA. GENERAL SKILLS:

Leadership of departments of engineers, scientists, technicians, and facilities professionals.

Effective management of cross-functional teams where strong leadership and proven oral and written communication skills are required to meet Quality, Timeline, and Budgetary constraints.

Technical writing skills with experience writing procedures, protocols, reports, contract and internal batch records, requests for proposals, quality documents, and submissions to regulatory agencies.

Management of both internal departments and external contract resources.

Facilities Management of multi-building Pharmaceutical Manufacturing and R&D Sites.

Development and maintenance of large capital and operations budgets. TECHNICAL SKILLS:

cGMP Regulatory Experience

Subject Matter Expert for routine (FDA, EMA, MHRA) and PAI (FDA, ANVISA) inspections.

Authored various sections of CMC regulatory documents for FDA and EMA submissions.

Technical support and troubleshooting of regulated products.

Process, computer, and equipment validation - IQ, OQ, PQ.

Cleaning validation and cleaning changeover in multi-product liquid and solids facilities.

Quality Investigations and issue resolution (deviations, investigations, CAPAs, change controls).

SOP and manufacturing batch record authorship.

Development of GMP procedures for facilities start up, recovery, maintenance, and release.

Development of quality metrics monitoring deviation, CAPA, SOP, and Training compliance.

Experienced with various electronic Quality Management Systems (QMS).

Use of DOE and FMEA tools.

Engineering and Project Management

Proven ability to meet the Quality, Timeline, and Budget requirements of complex projects.

Experienced at taking projects from the conceptual design through to the final validated systems on projects ranging from small processes to integrated multimillion dollar cGMP commercial facilities.

Working engineering knowledge of all pharmaceutical utilities and process systems.

Experience specifying, ordering, starting up, and qualifying process & utility equipment.

Engineering and Project management of multi-million-dollar capital projects for manufacturing equipment and on all normal building and specialized pharmaceutical/laboratory utility systems. Aseptic Liquid and Solid Dosage Process Development and Manufacturing

Liquids, liposomes, and gels containing small molecules, proteins, oligonucleotides, and cytotoxics.

Sterile bulk process systems, autoclaves, and integrated vial-wash/tunnel/filler filling lines.

Aseptic processing including aseptic formulation and syringe and vial filling.

Solid processing equipment (blending, granulation, tableting, coating, etc.), facilities, and safety.

Packaging and labeling.

Contract Manufacturing (CMO) of Sterile formulations and Solid Dosages. Joseph Robert Tunner, Ph.D.

PACIRA Pharmaceuticals, San Diego, California, 2008 - 2024 Director and Engineering roles

Leadership positions as Director Facilities Engineering, Director of Engineering, Facilities, and Validation, Director of Engineering, Director of Manufacturing Engineering & Technical Support, and Principal Engineer. Directed two engineering groups and multiple cross functional projects. Led final design of highly complex sterile processing skids for aseptic formulation of a liposomal drug product. Led MSAT team performing drug product characterization, container closure development, DOE based process characterization, and sterile filtration qualification. Managed the expansion/upgrade/replacement of major components of all clean utility and plant systems, as well as on- going process system and building maintenance and compliance with a $15M+ operating budget. GMP systems included WFI, Clean Steam, RODI, Nitrogen, and CCA, both generation and distribution. Non-GMP systems include steam boilers and plant steam distribution, chillers, cooling towers, HVAC and waste neutralization and solvent recovery systems.

Responsible for major manufacturing facility expansions from $6M to $20M in size. During downsized corporate transition period, responsible for maintenance of commercial manufacturing and validation compliance, authorship of a key CMC section of the NDA, and defended multiple regulatory inspections. FAVRILLE Inc., San Diego, California, December 2005 – June 2008 Associate Director / Director, Manufacturing Engineering Directed the design, construction, and start-up of a commercial pharmaceutical cell culture plant, aseptic fill suite, laboratories, and separate corporate headquarters. The $25M project was restricted by an extremely tight timeline and budget, while being required to meet all cGMP quality requirements. Authored the Facility CMC section for the NDA and FDA Facility design review package.

PFIZER RESEARCH AND DEVELOPMENT, La Jolla, California, August 2002 – September 2005 Principal Scientist, Pharmaceutical Research and Development Represented Pfizer Pharmaceutical Sciences, La Jolla for manufacturing and development of a Phase II/III AIDs medication contracted at 100 kg scale in Germany. Directed the startup of the La Jolla Clinical Manufacturing cGMP pilot plant. Managed the Solid Dose Manufacturing and Packaging and Labeling groups at La Jolla. MATRIX PHARMACEUTICAL Inc. / MATRIX CONTRACT SERVICES, 1997 - 2002 Manufacturing & Senior Manufacturing Engineer

Managed the technology transfer of contract manufactured products to Matrix Contract Services (CMO), working with customers to select and specify equipment components, draft manufacturing batch records, and establish cleaning and cleaning verification procedures. Transferred and scaled up the formulation of customer parenteral products, including a cytotoxic, non-aqueous, viscous solution for aseptic vial filling. Managed the Manufacturing Engineering Department. This group was responsible for equipment design and technology implementation, process improvements, equipment qualification, and technical support of manufacturing operations. Responsible for the scientific and technical aspects of the sterile manufacturing process used to supply both clinical and NDA enabling lots of sterile collagen gel. In conjunction with Process Development scientists transferred a commercial scale sterile collagen gel manufacturing process from the development laboratory to the manufacturing suite. Performed site transfer of the manufacturing process from San Jose to San Diego.

HYBRITECH Inc, San Diego, California, 1993 - 1997

Senior Tech. Ops. Scientist, Research Scientist, Mfg. Tech. Support Engineer Directed process improvements and troubleshooted failures for antibody-based processes and diagnostic tests using DOE tools. Provided engineering support of commercial manufacturing dealing with FDA 483 observations associated with Cleaning Validation of a multi-product facility. Contributed to the preparation of a parenteral drug manufacturing facility for a CBER (Center for Biologics Evaluation and Research) pre-license inspection and product launch. SELECTED HONORS:

Invited speaker at the San Diego ISPE Project Planning and Design Panel dinner presentation Chancellor’s Recognition Award from the University of Colorado Eagle Scout, Boy Scouts of America

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