Senior/Principal Scientist - Process Development CMC
EnVivo is developing its broad pipeline of diverse programs with a focus on leveraging novel mechanisms of action to treat CNS diseases like schizophrenia and Alzheimer’s disease in new ways and from multiple angles. Our approach is multi-target and multi-program by design - with no therapies currently available to treat the underlying causes and mechanisms of many CNS diseases, the scientific expertise and drug discovery ability to pursue a variety of disease targets is key. EnVivo has created a diverse pipeline of promising drug programs with mechanisms that could alter the progression of disease or provide sustained improvement in function to patients with serious CNS disorders, including Alzheimer’s disease, schizophrenia and others.
We are well financed and strongly positioned to develop and commercialize our own programs. Our primary goal is to rapidly and effectively translate our promising research and development programs into safe and effective CNS therapies for patients. As we also work to build an integrated drug company, our strategy is to retain a meaningful lead role in development and commercialization of our programs in certain indications and geographies, while also seeking to strategically partner our programs in order to fully realize the promise and potential of our pipeline.
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 in Organic Chemistry with 8 years of pharmaceutical experience or MS Degree with 15 years pharmaceutical experience for Principal Scientist.
The following are preferred:
- Organic chemists with large scale process chemistry experience.
- Good understanding of analytical chemistry a plus.
- Excellent experience trouble-shooting issues at vendors responsible for cGMP manufacturing.
- Good working knowledge of GMP and regulatory requirements.
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment.
- Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment.
- Excellent oral and written skills.
- CMC Regulatory Writing/Review experience a plus.
- Must be able to travel upon occasion to vendor and contract manufacturer sites.
EnVivo Pharmaceuticals offers its employees a dynamic, entrepreneurial environment that places great value on individual creativity within a team setting. EnVivo’s workplace breeds new ideas and encourages employees to create opportunities for themselves. By joining the EnVivo team, employees not only gain access to the company’s many resources, they also find a platform that supports science that is making a difference in CNS patients’ lives. EnVivo’s corporate culture values integrity, teamwork, and leadership. Each employee is encouraged to have an active voice to help further the company’s business objectives - and that voice is heard and incorporated into the larger company dialogue. EnVivo offers employees very competitive compensation and benefits package that includes employee stock options, healthcare and dental coverage, life and AD&D insurance, and a 401(k) plan.
NO AGENCIES, PLEASE