Robert "Pete" Pullen, Ph.D. Email & Phone Number

Panama City Beach, Fl, Us

Baltimore, Maryland Area

Offers Pharmaceutical Companies, Contract Research Organizations and Contract Manufacturing Organizations Analytical support services including:• Analytical Development • CMC Submissions • Stability • Tech Transfer • Program Management • Lab Operations Pete has over 29 years of Pharmaceutical industry experience in leadership and technical positions at Upjohn, ICI, Solvay and most recently, Shire Pharmaceuticals. During his 15 years at Shire, Pete led large scientific/technical organizations responsible for analytical development/QC, authoring CMC content, and providing technical support for internal and external manufacturing operations. He was a key player in the development and launch of multiple new products at Shire. Pete also directed commercial technology transfer at Shire, including the transfer of all products from Shire’s internal manufacturing site to a CMO. Pete will apply his analytical expertise, unique breadth of experience, and ability to consistently achieve project deliverables to fulfill client analytical, CMC, or laboratory project needs.

Owings Mills, Md

Technology Transfer Governance Team Leader for Shire’s Global Supply Chain (GSC). Managed Engineering and Maintenance at the 170,000 SF Owings Mills manufacturing site. On Leadership Team for the Owings Mills Plant and Global Pharmaceutical Technology.• Earned Recognition Award from the Global Supply Chain Leadership team for on-time completion of Technology Transfer of all products from Shire’s manufacturing facility to a CMO. • Led Transition Team for the Owings Mills plant closure program. Delivered 3 year program on target, for time, costs and deliverables. Achieved with a remarkably low rate of unexpected employee departures.

Owings Mills, Md

Directed Pharmaceutical Analysis, Global Technical Services, Validation, and Process Improvement operations for the GSC. Led internal/external technology transfers, process optimization, technical services, validation execution, and associated laboratory support. Developed functional strategic initiatives, budget, training, manpower, capital and project plans for GPT. On the GSC Leadership Team; reported to Head of GSC for Shire’s $3B Specialty Pharma Business.• Sponsored Lean Six Sigma laboratory initiatives to optimize space, deliver 24-hour sample results and provide critical real-time data sharing to Manufacturing. • Completed technology transfer, registration and manufacturing validation to enable launch of VYVANSE capsules and Shire’s new ADHD drug INTUNIV from Owings Mills. • Project champion for 5 concurrent drug product technology transfer projects to Shire’s strategic manufacturing partner (24-month project). Met all key deliverables for time, cost and quality.• Sponsored creation of a commercial product characterization program and a dedicated team. Resulted in improved process controls and reduced batch failures for priority projects.

Owings Mills, Md

Led analytical staff of 55 in support of CMC submissions, technology transfers, manufacturing validation, and stability at Owings Mills and contract facilities. Oversaw Quality Control (chemistry and microbiology) release and marketed product stability for onsite commercial manufacturing.• Kept up with accelerated manufacturing demands by establishing a 2nd shift QC operation, raw materials testing group, and pharmaceutical analysis support for technology transfers.• Established Laboratory Services which provided dedicated support for data systems, calibration, stability and training. Lab operations passed FDA inspection in 2005 with no 483 observations.• Managed LIMS implementation project to improve lab efficiency and compliance. Delivered on-time and on-budget and project went live 9 months after kick-off.

Rockville, Md

Directed analytical support for methods and specification development, CMC submissions content, formulation, clinical supplies, stability studies and bioanalysis of developmental and marketed product dosage forms. Supported internal projects and programs for external clients. Led 50 personnel in Pharmaceutical Analysis, Laboratory Services and Bioanalytical Sciences.• Lead CMC role in 10 IND filings and 2 approved NDAs for CARBATROL (carbamazepine extended-release capsules) and ADDERALL XR (mixed amphetamine salts extended-release capsules). A 3rd development product, IINTUNIV, was approved in 2009.• Received annual employee Recognition Award for observation-free lab PAI and FDA approval for ADDERALL XR line extension, 2003.• Inspection co-lead for a successful PAI in February 2001 which concluded with FDA Investigator approval recommendation for ADDERALL XR NDA; Shire’s first blockbuster product.• Lead technical manager for 25 CMC supplements approved for changes which supported Shire’s rapid US growth. • Analytical Lead for Regulatory Agency meetings and teleconferences; answered Agency questions on analytical topics.• Sponsored upgrades of critical laboratory systems including software, automation, and instruments to deliver analytical and bioanalytical data for Shire Lab’s growing developmental pipeline.

Marietta, Ga

Ph.D., Analytical Chemistry

Bs, Biology, Chemistry

Master Of Arts (M.A.), Chemistry