Jeffrey Lapointe Email & Phone Number

Providence, Rhode Island Area

• Partner with a cross functional team of automation, process engineering, process development, and quality as manufacturing support to accomplish key tasks in a deadline based environment in support of capital projects.• Review, revise, and design batch records to control for process parameters, regulatory requirements, and manufacturing expectations. Hold virtual batches with affected departments to ensure accuracy of batch records and procedures. Additionally, create and revise Functional Specification (FS) documents for batch record design. • Revise existing procedures in support of new product introduction while constantly maintaining a quality mindset and leveraging operator feedback. Created new process SOP in support of Enbrel New Formulation (ENF) downstream process utilizing automation and engineering documents to ensure right first time operation.• Authored and involved with execution of engineering test plan (ETP) for Enbrel New Formulation (ENF) utilizing a previously rejected lot of drug substance to ensure the ENF process performed according to specifications and design.• Attended and supported Factory Acceptance Testing (FAT) and Software Acceptance Testing (SAT) of new equipment to ensure alignment with manufacturing practices.

*Performed critical downstream operations in a highly cGMP environment. Operations include high flow UF/DF, Chromatography operations, Viral Filtration, numerous product titrations, and CIP/SIP*Key member of column packing teams across multiple products. Operations included column packing and qualification in a dynamic team based environment.*Initiated, owned, and closed non-conformance (NC) events while achieving compliance with FDA regulations. Specifically recognized by plant quality and my management due to my technical writing capability.*Highly proficient on analytical testing, including UV Spectroscopy and Endotoxin testing.*Excellent problem solving skills. I have been involved in advanced real-time troubleshooting of *Downstream process equipment using process trends, Requirements & Design documents, P&ID’s and solid Engineering practices. In all cases, the decisions implemented resulted in successful product purification.*Safety Oriented and focused on compliance: All operations are performed with safety and procedural compliance as a top priority. I embrace error proofing tools such as Reader/Doer, pre evolution briefs, and continuous learning*Team Oriented: All floor operations performed in a team based environment. Additionally, I routinely partner with other departments to complete complex tasks (Automation, Maintenance, Plant Quality)

* Worked independently and collaboratively with engineers and technicians to improve polymerization department processes* Regularly recorded data and took samples with minimal supervision* Assisted information systems to create SharePoint intranet site for the department* Created automatically updating trends for the group with Microsoft Access as well as Microsoft Excel by utilizing historian plugin* Researched feasibility of new projects, including contacting vendors and obtaining quotes from contractors* Updated standard operating procedures and lockout/tagout documents* Worked with technicians to improve ergonomics of different processes

* Facilitated weekly sessions in the subject of Calculus 2 to help clarify concepts, go over difficult problems, and prepare students for exams by managing large groups of students* Accomplished tasks with minimal oversight, including, but not limited to, making lesson plans, creating practice exams, finishing paper work accurately and on time* Met with course instructor regularly to ensure consistency with course concepts and to identify student needs

Performed data entry, file management, and administrative tasks.

* Took and passed nuclear safety exam regarding how to handle radioactive materials safely* Used Neutron Activation Analysis to identify elements in local rainwater * Looked for radioactive elements from Fukushima incident in the air