Senior Lead Scientist

Role Summary

Senior Lead Scientist role focusing on API supplier assessments, analytical method transfer, and cross-functional leadership within analytical development and sourcing. The role interfaces with CMOs and internal teams to define method transfer strategies, coordinates end-to-end transfers, and serves as a scientific resource across the organization. The position involves investigating process issues, supporting scale-up, and collaborating with HR on employee matters as needed.

Responsibilities

• Overall assessments of alternate API suppliers for commercial products by working with R&D API sourcing team and other related groups to support commercial products manufacture.
• Possess knowledge/skill to discuss and/or perform analytical testing on a range of API sourcing samples using methods including NMR, HPLC, LC-MS/MS, GC, DSC, TGA, CD, UV, and IR spectroscopy.
• Critically evaluate and audit data.
• Write API sourcing reports for alternative supplier source selection.
• Interface with CMOs and cross-functional teams to define analytical method transfer strategy and provide routine project updates.
• Lead and coordinate the end-to-end process of transferring analytical methods across external sites.
• Develop and support analytical method transfer and execution, including providing method transfer materials, preparing AMT protocol, reporting and auditing AMT results across Donor and Recipient sites.
• Lead and participate in scientific investigations and troubleshoot process issues that arise during analytical transfer, or scale-up.
• Work with Human Resources in interviewing, performing employee appraisals, directing disciplinary actions, and resolving employee issues.
• Serve as department representative internally to other departments or subsidiaries and externally to third-party laboratories, manufacturers, and/or regulatory agencies.
• Act as a scientific resource for the Company.

Qualifications

• Knowledge of the wide variety of analytical methods common to the pharmaceutical industry, industry practices, and health authority regulations and guidances.
• Strong analytical chemistry background including familiarity with the wide variety of methods common to the pharmaceutical industry.
• Subject matter expert (SME) for Analytical Method Validation and transfer.
• Must maintain comprehensive and meticulous records of experimental protocols, results, and data analyses, ensuring data integrity and compliance with all EH&S and regulatory standards. Must possess strong communication and reading skills. Basic working knowledge of Microsoft Office. Must be able to effectively operate a computer-based data acquisition system for chromatography. Must be able to multi-task to work on multiple projects at the same time.
• Ability to work effectively in a cross-functional team environment.
• Process experience in drug substances and drug products.
• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
• Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
• Combination of experience and/or education will be taken into consideration.

Education

• Bachelor's degree (or equivalent) required; advanced degrees (Master's or Doctorate) preferred. Combination of experience and/or education will be considered.

Additional Requirements

• Physical demands typical of a normal office and chemical laboratory setting; may include sitting for long periods, standing, walking, bending, kneeling, climbing steps, use of hands and arms, and sedentary lifting requirements.