Senior Scientist/Principle Scientist, Formulation Development EnVivo Pharmaceuticals
THIS JOB HAS EXPIRED This position provides an opportunity to join a growing Drug Development Department and contribute substantially to the successful formulations, clinical manufacturing and commercial scale up 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 key member of the CMC Drug Development Team, you will work closely with the Associate Director of Formulation Development on drug product development from lead optimization through commercialization. The qualified candidate should have experience in formulation development, process selection, GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs) as well as scientific and project management of external drug product vendors. The preference will be given to candidates who have demonstrated excellent lab skills, preformulation experience and capability to problem-solve formulation challenges, implementation of innovative technologies and scale up experience based on Quality by Design (QbD).
Responsibilities will include but are not limited to the following:
Responsible for formulation development, manufacture of clinical supplies,
development of efficient and scalable manufacturing processes, process scale up
based on Quality by Design (QbD).
Manage project activities and timelines. Liaise with vendor and/or CRO regarding
project activities and deliverables.
Generate, maintain and review drug product development documents, manufacturing batch records, and other study related documents.
Generate and review regulatory filing materials for trials both in the US and
Generate and/or review pertinent SOPs and guidance documents pertaining to execution of relevant CMC activities.
Participate in cross-functional teams.
Work with Legal and Finance to generate MSAs, CDAs, and project orders in support of CMC projects.
Support the filing of formulation patents.
Pharmaceutical experience with at least 5 years with Ph.D. or a M.S. with at least
8 years in Pharmaceutics, Pharmaceutical Science or a related discipline.
Excellent interpersonal skills, with a demonstrated ability to work in a team environment.
Good understanding of analytical development a plus.
Excellent experience trouble-shooting formulation issues at vendors.
Good working knowledge of GMP and regulatory requirements.
||480 Arsenal Street |
Watertown, MA 02472
THIS JOB HAS EXPIRED