Position SummaryThe Principal Scientist has direct responsibility for the development of robust, safe, and cost effective chemical processes for the scale-up and manufacture of active pharmaceutical ingredients (APIs). Responsible for the design and execution of in-house laboratory experiments, data analysis, and interpretation in support of successful technical transfer to contract manufacturing organizations (CMOs). Responsible for managing API production activities at the CMO during the product lifecycle. Position includes working cross-functionally with Analytical, Drug Product, Regulatory, QA, and Project Management staff, both internally and at CMOs.
- Responsible for in-house laboratory research into the development of safe, robust, and efficient API manufacturing processes for early-to-late stage development candidates suitable for introduction into a pilot plant and manufacturing using an outsourcing model.
- Applies fundamental process chemistry principles to characterize and solve process challenges in scale-up.
- Define critical process parameters, control strategies, and critical quality attributes.
- Responsible for leading successful technology transfers to CMOs and timely manufacture of API in support of early and late stage clinical requirements.
- Ensure that API development and manufacturing activities are conducted in compliance with all cGMPs and applicable regulatory requirements.
- Lead the selection and engagement of CMOs.
- Responsible for cultivating productive business collaborations with API CMOs using key performance indicators as appropriate.
- Empowered Chemical Development representative on CMC and Program Development Teams.
- Proactively manages API development and manufacturing risk.
- Serve as subject matter expert in authorship of API-related CMC regulatory documentation.
- Prepare technical reports, patent application content, publications and oral presentations as necessary.
- Up to 20% business travel expected.
- Ability to independently plan, organize, and manage multiple projects simultaneously.
- Demonstrated ability to work effectively in a matrix organization.
- Excellent oral and written communication skills for effectively interfacing at all levels of the company and externally.
- Entrepreneurial and enjoys working in a fast-paced, creative, and resourceful small company environment.
- Collaboration & Teamwork: Relates to employees and management in a cooperative manner that helps others to achieve their best.
- Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Communication Skills: The ability to convey both written and verbal information effectively and efficiently.
- Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
- Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.
Education, Prior Work Experience, and Specialized Skills and Knowledge
- Ph.D. in chemistry or chemical engineering.
- Demonstrated experience in API process research, development and manufacturing.
- First-hand experience in developing efficient synthetic processes and scale-up into kilo-lab, pilot plant and manufacturing.
- Excellent working knowledge of Regulatory, cGMPs, industrial hygiene and process safety requirements.
- Experience with API technology transfers to CMOs and post-transfer management.
- Experience arranging and managing external contracts and tracking budgets.
How to Apply
Please complete the application below and include the following attachments:
Research Summary (if applicable)
Enanta Pharmaceuticals has used its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Two protease inhibitors, paritaprevir and glecaprevir, discovered and developed through Enanta’s collaboration with AbbVie, have now been approved in jurisdictions around the world as part of AbbVie’s direct-acting antiviral (DAA) regimens for the treatment of hepatitis C virus (HCV) infection, including the U.S. marketed regimens MAVYRET™ (glecaprevir/pibrentasvir) and VIEKIRA PAK® (paritaprevir/ritonavir/ombitasvir/dasabuvir).
Enanta is located in Watertown, MA, just minutes from Harvard, MIT, and downtown Boston. We offer a competitive compensation program and a comprehensive employee benefits package. For more details, see our Careers page.
Enanta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.