Senior Scientist/ Principal Scientist, Process Development EnVivo Pharmaceuticals
This position provides an opportunity to join a growing Drug Development Department and contribute substantially to the successful characterization, scale up, and manufacturing of novel CNS medications. In addition, there is an opportunity to expand your knowledge in the field of CNS research through day-to-day activities and close interactions with the Research and Clinical groups within EnVivo.
As a member of the CMC Drug Development Team, you will work closely with the Principal Scientist of Process Development on the identification, technology transfer as well as scientific and project management of external CMC vendors. In addition, the candidate will work with both the CMC and quality teams to ensure that high quality clinical trial materials and regulatory documentation are produced in support of on-going development programs. The ideal candidate will have shown proficiency in both knowledge and ability to manage and solve CMC challenges in a highly regulated pharmaceutical environment. The position requires a strong background in Process or Chemistry as the ideal candidate will be asked to develop and execute scientific strategies at external vendors, as well author/review documents for regulatory and patent purposes. Large scale manufacturing experience required. Preference will be given to candidates who have demonstrated excellent lab skills and the capability to problem-solve CMC challenges proficiently via sound experimental design.
Responsibilities will include but are not limited to the following:
Generate technical packages and transfer to external contract manufacturers. Manage project activities and timelines; organize and participate in cross-functional teams.
Generate, maintain and review drug development and CMC documents, vendor documents, manufacturing and batch records, and other study related documents.
Liaison with vendor and/or CRO regarding project activities and deliverables
Generate and manage work plans
Participate in vendor trouble-shooting efforts.
Generate and/or review pertinent SOP and guidance documents pertaining to management and execution of CMC activities. Generation and review of regulatory filing materials for trials both in the US and abroad.
Support Quality Assurance to maintain and ensure high quality of documents in compliance with GMP
Perform evaluations, technical audits and site visits of vendors. Work with Quality Assurance to support quality audits and establish quality agreements.
Work with Legal and Finance to generate MSAs, CDAs, and project orders in support of CMC projects.
Support the filing of CMC related patents.
Participate on cross-functional development teams.
Ph.D. in Organic Chemistry with 5 years of pharmaceutical experience or MS Degree with 10 years pharmaceutical experience for Senior Scientist.
Ph.D in Organic Chemistry and 8 years of pharmaceutical experience or MS Degree and 15 years of pharmaceutical experience for Principal Scientist
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