Sr Scientist II (Process and Lab Manager)

Role Summary

The Senior Scientist II (Process and Lab Manager) focuses on research using equipment in process and high potency labs to define process reactions, safety parameters, and solid characterization of intermediate and final API. The role includes evaluating and developing IPC methods for early-stage discovery projects to enable smooth scale-up for pre-clinical and IND enabling studies, performing tech transfers of IPC and release methods, and identifying process impurities in collaboration with chemists to develop safe, reproducible, and scalable processes.

Responsibilities

• Work with process teams to facilitate scale up of building blocks, intermediate and drug candidates.
• Maintain equipment in good working condition and troubleshoot issues.
• Manage inventory for internal intermediate and API and for CDMOs.
• Partner with chemists to evaluate and develop IPC methods for early-stage discovery products, facilitating smooth scale up for supply of compounds.
• Execute all required data using analytical and safety equipment to support in-house process development and optimization studies to facilitate scale up and transfer to CMOs.
• Collaborate with project teams to source appropriate quality starting materials.
• Prepare technical packages for transfer of processes parameters to internal analytical lab and CMO/CRO partner facilities.
• Keeps abreast of relevant publications and guidance documents.

Qualifications

• Bachelor‚Äôs degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 9 years of relevant experience in the biotech/pharmaceutical industry; or,
• Master‚Äôs degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 7 years of relevant experience in the biotech/pharmaceutical industry; or,
• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Science or related field and a minimum of 2 years of relevant experience in the biotech/pharmaceutical industry; or,
• Equivalent combination of education and experience.

Skills

• A demonstrated track record of delivering results with high integrity, quality focus and collaboration.
• Knowledge of characterization of the physical and chemical properties of compounds of interest.
• Knowledge of process chemistry, synthetic organic chemistry, analytical methods (MS and HPLC, Karl Fischer, Reactarry, LC/MS, GC/MS, flow reactor, RCI, DSC, TGA, XRPD, PLM and milling) for physical-chemical characterization of compounds.
• Excellent interpersonal skills, oral and written communication skills.
• Excellent organizational skills, with ability to successfully manage multiple priorities.
• Ability to work effectively with cross-functional teams.
• Highly self-motivated and detail-oriented, with proven ability to work independently.

Education

• As listed in Qualifications above.