Senior Scientist II, Analytical Development

The Opportunity:

• Lead day-to-day operations to provide analytical support for API process R&D and manufacturing, formulation development and drug product manufacturing, and participate in cross-functional project team meetings.

• Contribute to analytical development strategy for multiple projects.

• Demonstrate technical expertise on analytical technologies and act as a subject matter expert for Analytical Development function.

• Select appropriate analytical techniques and coach and/or manage the contract lab counter parts to perform analytical method development/validation/transfer to support development and manufacturing of API and drug product.

• Critically review data from contract partners (CDMOs and/or CTLs).

• Manage stability testing programs assigned.

• Prepare, review, and/or approve study protocols, study reports, and CMC regulatory submission document.

• Collaborate with cross functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, QA, Pharmaceutical Development, Process R&D, Project Management and Regulatory to timely achieve project goals.

Required Experience, Skills and Education:

• Master’s degree with 10+ years or PhD with 8+ years of relevant industrial experience in analytical development.

• Extensive experience leading analytical activities independently in small molecule drug development.

• Experience managing projects at CROs/CDMOs.

• Work experience and knowledge of regulatory submission (IND, IMPD, and / or NDA).

• Effective written and verbal communication skills and interpersonal skills.

• Extensive knowledge and understanding of current ICH guidelines, GMP guidelines, and related industry practices.

• Strong problem-solving skills with sound technically driven decision-making ability.

• Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

Preferred Skills: 

• PhD (minimum MS degree) in analytical chemistry, organic chemistry or related discipline.

#LI-CT1 #LI-Hybrid