Sr Scientist I (Process Chemistry)

Role Summary

The Senior Scientist I, Process Chemistry, focuses on executing in-house process chemistry efforts at the process research and development lab. Works with medicinal discovery chemists to evaluate synthetic routes for early-stage discovery projects to facilitate scale up for pre-clinical supply, understands physical and chemical properties of compounds, performs solid state polymorph screening to define stable polymorphs for DS manufacturing, transfers processes to CMOs for clinical manufacturing, and collaborates with project teams for troubleshooting in ongoing manufacturing projects.

Responsibilities

• Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of target compounds and building blocks while providing insights for selection of development candidates.
• Execute in-house process development and optimization studies to facilitate scale up and transfer to CMOs.
• Collaborate with project teams to source appropriate starting materials.
• Prepare technical packages for transfer of processes to CMO/CRO partner facilities.
• Understand characterization of physical and chemical properties of compounds and perform solid state characterization and polymorph screening.
• Partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to ensure drug substances are delivered on time and within specification.
• Write and review CMC sections of regulatory filings when needed.
• Stay informed of relevant publications and guidance documents.

Qualifications

• Bachelor‚Äôs degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 7 years of relevant experience; or
• Master‚Äôs in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 5 years of relevant experience; or
• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field with 0 or more years of relevant experience; or
• Equivalent combination of education and experience.

Experience

• Demonstrated track record of delivering results with integrity, quality focus and collaboration.
• Experience in solid state characterization and polymorph screening is a plus.

Knowledge, Skills And Abilities

• Knowledge of process chemistry, synthetic organic chemistry, analytical methods (NMR, MS, HPLC) and physical-chemical characterization of compounds.
• Ability to develop, optimize and scale up drug substance manufacturing processes; experience managing GMP contract manufacturing organizations is a plus.
• Excellent interpersonal, verbal and written communication skills.
• Excellent organizational skills with ability to manage multiple priorities.
• Ability to work effectively with cross-functional teams.
• Highly self-motivated, detail-oriented, and able to work independently.

Education

• As listed in Qualifications (see above).

Additional Requirements

• None.