Peter Colvin Email & Phone Number

Lansdale, Pa, Us

West Point, Pa

Primary responsibilities include:- Enabling and leading Sterile Operational Readiness of the new state-of-the-art clinical manufacturing facility for Sterile Quality Operations- Leading efforts in sterile knowledge and capability build- Contributing as a sterile product SME to key investigations.

Associate Director (management track) within the Laboratory & Technical Operations group of the Sterile Liquid Commercialization department. Key responsibilities include:- Providing strategic leadership to ensure lab assets meet current & future capability and capacity needs- Leading capital project initiatives focused on renovating existing assets and purchasing new equipment- People management of full-time and contract staff- Providing technical support for activities within the new sterile DP scale-up lab (pipeline and commercial products)- Serving as HR SME for the dept., including recruiting, new leader coaching, and intern/co-op program

West Point, Pa

Responsible for leading late-stage drug product development and tech transfer of sterile pharamceuticals.Responsible for direct people management and development of a team of engineers & scientists. In addition, responsible as the client manager for a staff of 15 contract scientists.Wide range of drug product development experience, including:- small molecules, biologics (including biosimilars), and vaccines- products for use with medical devices (e.g. pre-filled syringe in an auto-injector and cartridge in a pen injector)- IV, IM, and ophthalmic (including blow-fill-seal) drugs- Experienced in leading cross-functional product definition teams (including colleagues from formulation dev, analytical, supply chain, quality, regulatory, procurement, and marketing)- Experienced in global technology transfer to internal sites and CMOs. Proficient in building strong cross-cultural relationships, including partners in France, Germany, Ireland, Finland, the Netherlands, and Japan.

West Point, Pa

Responsible for leading late-stage drug product development of sterile pharamceuticals.Wide range of drug product development experience, including:- small molecules, biologics (including biosimilars), and vaccines- products for use with medical devices (e.g. pre-filled syringe in an auto-injector and cartridge in a pen injector)- IV, IM, and ophthalmic (including blow-fill-seal) drugs- Experienced in leading cross-functional product definition teams (including colleagues from formulation dev, analytical, supply chain, quality, regulatory, procurement, and marketing)- Experienced in global technology transfer to internal sites and CMOs. Proficient in building strong cross-cultural relationships, including partners in France, Germany, Ireland, Finland, the Netherlands, and Japan.

West Point, Pa

Served a 5-month rotational assignment as interim leader of the Process Engineering Group in Merck's Sterile Pilot Plant. Responsibilities included:- Managing a staff of 8 engineers- Distributing project assignments and balancing workload- Holding regular 1-on-1's to provide coaching, feedback, and technical direction- Coaching staff to prepare and take action on Employee Development Plans- On-boarding two new engineers to the group- Approving change controls- Leading and authoring the product impact assessment for two major deviations- Representing the Process Group at three levels of Tier meetings

West Point, Pa

- Support late-stage development and tech transfer of sterile drug products, from Ph III through PPQ.- Responsible for planning, execution, and data analysis of laboratory experiments to support process definition and deviation investigations. - Certified as a Lean Six Sigma Green Belt through the development of qualification process for the manual visual inspection of sterile products.

West Point, Pa

- Coordinated manufacturing of sterile drug products for use in clinical and stability studies.- Developed a rationale and methodology for cleaning verification in a multi-use pilot facility.- Subject Matter Expert for manual visual inspection of sterile drug products and inspector qualification

Staff Chemical Engineer, Sterile Pilot Plant

Responsible for working with product development staff to develop pilot-scale manufacturing process for sterile products. Lead pilot plant engineer for 20+ sterile products, including small molecules, biologics, vaccines chemotherapeutics, and radio-labeled compounds. Coordinated pilot-scale manufacturing for clinical supplies (Phase I, Phase II, Phase III) and stability studies. Authored batch records, supervised pilot manufacturing, prepared release documentation. Responsible for investigating atypical events and writing deviation reports. Authored CMC sections to support clinical filing submissions.

Master Of Science (M.S.), Chemical Engineering Practice

Bachelor Of Science (B.S.), Chemical Enginnering, Graduated With Highest Distinction

High School Diploma, 5.876 / 6.0 (Class Rank 8/793)

Activities and Societies: National Honor Society, National Merit Commended Student, Eagle Scout