Position Summary:    

Direct responsibility for the development of robust, safe and cost effective chemical processes for the scale-up and manufacture of small molecule drug substance. 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 (CMO’s). Position includes working cross-functionally with analytical, drug product, regulatory, QA and Project Management staff, both internally and at a CMO.



Primary Duties and Responsibilities:
 
  • Responsible for early to late stage development of drug substance including process optimization, scale-up, technology transfer to CMO/CDMOs, and solving manufacturing problems.
  • Identify process gaps and carry out risk assessment to ensure robust processes are in place for manufacturing of starting materials, intermediates, and drug substances to support clinical development and commercialization.
  • Managing and support internal kilo lab operations.
  • Integrate quality by design (QbD) and risk management principles to process development of drug substance. Define critical process parameters, control strategies, and critical quality attributes. Design and perform DOE study.
  • Empowered Chemical Development representative on CMC and Program Development Teams.
  • Produce high-quality data for inclusion in drug substance related CMC regulatory documentation.
  • Prepare technical reports, patent application content, publications and oral presentations as necessary.

Functional Qualifications and Requirements:
 
  • Advanced degree in synthetic organic chemistry, Ph.D. preferred
  • Sound knowledge of organic chemistry principles
  • Experience in chemical process research, development, scale-up and manufacturing is a plus
  • Experience with process development tools (EasyMax, reactors, PAT etc.) is a plus
  • Experience with process validation, Design of Experiments is a plus
  • Experience and knowledge of GMP compliance, and relevant ICH quality guidelines is a plus
  • 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
  • Up to 10% business travel expected


General Qualifications:
 
  • Interpersonal Skills - Must have good interpersonal and communication skills needed to establish and maintain positive relationships with co-workers and external partners.
  • Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences  
  • Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously
  • Strategic Thinking – Capable of strategic thinking and proposing innovative solutions to resolve manufacturing problems both in the drug substance and drug product
  • Collaboration & Teamwork – Strong aptitude to be part of a multi-discipline team, driven by the success of the team.   Ability to influence others, overcome and embrace change, plan & organize, drive results and problem solve

Education and Experience Requirements:
 
  • Advanced degree in synthetic organic chemistry, Ph.D. preferred
  • Work experience: 0-5 years of relevant post-doctoral or industrial experience for Ph.D. or 5-10 years of relevant industrial experience for M.S.
 

How to Apply

Please complete the application below and include the following attachments:

  • Cover Letter
  • CV / Resume
  • Research Summary (if applicable)
 
About Enanta

Enanta Pharmaceuticals is using 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. Enanta’s research and development efforts are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH)/ primary biliary cholangitis (PBC), and hepatitis B virus (HBV).  Please visit www.enanta.com for more information.

Enanta’s research and development activities are currently funded by royalties from HCV products developed under its collaboration with AbbVie.  Glecaprevir, a protease inhibitor discovered by Enanta, is now sold by AbbVie in numerous countries as part of its newest treatment for chronic hepatitis C virus (HCV) infection. This leading HCV regimen is sold under the tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir).

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.

This is a full time position

Visit Careers at Enanta Pharmaceuticals

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