The Scientist/Senior Scientist, Analytical Method Development will be responsible for all aspects of analytical development including characterization for drug substances and drug products. This position is responsible for performing analytical method development and support for drug substance development, formulation development, manufacturing, stability, characterization and control.
- Provide internal analytical method development for drug substance and drug product using techniques including HPLC, UPLC, LCMS, Karl Fisher, dissolution, solid state characterization, IR, and GC.
- Provide analytical oversight of external vendors for preclinical and Phase I - II CMC activities for small molecule drug substance and drug product.
- Manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs).
- Phase appropriate development, validation and transfer of analytical methods for starting materials, in-process control, DS and DP testing.
- Participate in the development and revision of product specifications; provide scientific input and critique of analytical results.
- Review the quality control testing of clinical trial supplies performed at CMOs.
- Analyze stability studies for DS and DP.
- Review CMC sections of regulatory submissions along with other functional groups.
- Ability to Work Independently - Able to draft and negotiate contracts independently.
- Problem Solving and Research Skills - Able to think creatively to find common ground in contract negotiations and ability to conduct research to evaluate applicable laws, rules, regulations and guidelines.
- Organizational and Communication Skills - Outstanding organizational, written and verbal communication skills.
- Strong attention to detail – Focus on accuracy of details in all contracts.
- Team Player/Commitment to Cause – Understands the big picture and is able to manage position’s areas of responsibility in a manner consistent with the Company’s agenda.
- Integrity – Capacity to build trust among colleagues; is accountable; lives up to commitments.
- Interpersonal Skills – 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.
- Willingness to Acknowledge Areas for Growth – Understands need for personal growth and is receptive to constructive feedback.
Education and Experience Requirements:
- PhD, MS and BS degrees will be considered.
- Prior industry experience working on analytical method development for DS and DP is required.
- Ideal candidates will have vendor management experience.
- Ideal candidates will have experience reviewing and authoring regulatory submissions and partnering with regulatory bodies as necessary.
- Strong analytical, communication, presentation, and writing skills.
- Ability to strategically plan, organize and manage multiple projects simultaneously.
How to Apply
Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
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