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.
• 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).
• 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.
• 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.

* 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.

* 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.

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