Principal Scientist, Analytical Development
Job Description
The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and is a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. The Principal Scientist works within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre‑clinical research through drug development and commercialization. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision‑making and ensure the successful development of new drugs.
Responsibilities
- Serve as the primary Analytical Development representative on CMC teams, translate program objectives into phase‑appropriate analytical strategies, plans, and timelines.
- Provide strategic CDMO oversight for analytical activities, which may include product characterization, GMP in-process, release and stability testing, laboratory investigations, and method optimization.
- Provide subject matter expertise in analytical development methodologies, guide and drive analytical method development, method implementation, product characterization and analytical control strategy development for pre‑clinical and clinical stage development programs.
- Design, execute, and analyze analytical method validation and transfer activities suitable for progressive stages of small molecule pharmaceutical development that are in compliance with ICH and FDA guidance.
- Work closely with colleagues across Pharmaceutical Development and Research organizations to best leverage internal and/or external capabilities, equipment and instrumentation to identify and document critical factors to impact method performance.
- Develop, review, and approve analytical source documents, and author and review drug product and drug substance analytical sections for regulatory submissions.
- Present technical data to cross‑functional teams and senior management as an analytical expert, and effectively communicate critical analytical issues and solutions.
- Identify and advocate new and emerging technology opportunities for analytical and physical characterization.
- Train and mentor more junior Analytical Development staff, as needed.
- Perform other duties as assigned.
Qualifications
Basic Qualifications
- PhD with 8 years or MS with 15 years of related experience in analytical chemistry, organic chemistry, or biochemistry.
Preferred Qualifications
- Broad understanding of the drug development process and the role and impact of analytical development within this process.
- Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in the context of the stage of drug development.
- Demonstrated experience representing Analytical Development on CMC teams for both drug substance and drug product programs, driving analytical strategy and control strategies across phases.
- Proven track record of CDMO oversight/governance for analytical activities (method lifecycle, characterization, GMP testing, investigations), with delivery against scope, schedule, and quality.
- Expertise and demonstrated experience in small molecule analytical method development, validation and transfer.
- Technical problem‑solving ability utilizing current research and technologies.
- Demonstrated collaborative leadership, strong interpersonal skills, and excellent verbal and written communication skills.
- Subject matter proficiency across a range of spectroscopic, titration, dissolution and separation‑based analytical methodologies and laboratory software systems.
- Demonstrated ability to work successfully in a fast‑paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
- Previous experience with applying DoE in method development is preferred.
The annual base salary for this position ranges from $180,000 to $196,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.
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