Sr. Scientist, Analytical Sciences & Technology

Position Summary

The Senior Scientist is responsible for analytical method development for the testing of biologics, ADC's, and other protein modalities. You will lead the implementation of analytical methods for a variety of instruments and techniques to support pre-clinical to commercial stage client projects. You will perform non-GMP testing, pre-clinical stability studies, reference standard qualification, and comparability studies.

Duties & Responsibilities

• Lead analytical method development and demonstrate expertise with protein biotherapeutic test methods used to characterize products.
• Leverage a strong understanding of the drug substance process to lead testing of upstream and downstream process development samples.
• Document results and perform data analysis, interpretation, and trending.
• Design, author, and review standard operating procedures, methods, protocols, reports, change controls, and regulatory submission supporting documentation.
• Lead technical transfers to quality control and serve as an analytical expert for transfer and validation activities, investigations, method troubleshooting.
• Actively mentor less experienced scientists to facilitate their development.
• Identify opportunities for technical advancements and implement new analytical technologies.
• Lead analytical client interactions, support site inspections, review regulatory filings and prepare CMC inquiry responses as required.
• Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.
• Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.

Education & Experience

• B.S. in Biology, Chemistry, or equivalent area of related study with 7-9 years, M.S. with 3-6 years, or Ph.D. with 1-3 years, of industry experience in biologic/protein analytics.
• Experience in protein biotherapeutics for a variety of instrumentation (i.e., HPLC/UPLC, qPCR, ELISA, CE-SDS, iCIEF, UV-VIS, MS, GC, and cell-based assays) is required.
• Experience with the biopharmaceutical development process, ICH guidelines, compendial requirements, and experimental statistical design/data analysis is required.
• Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is required.
• Experience developing bridging studies between new and existing methods, method comparability studies, and product comparability studies required to support CMC changes is preferred.
• Experience leading analytical method change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s) is preferred.
• Experience defining analytical control strategy, coordinating the specifications development process, preparing the specification package documents, and driving the process for internal and regulatory approval of the specifications is desired.

Knowledge, Skills, Abilities

• Ability to interpret technical data and results to draw appropriate conclusions, apply risk-based quality principles, and identify logical next steps to ensure good scientific, compliance and regulatory outcomes.
• Strong verbal, written, presentation, and interpersonal communication skills with ability to clearly articulate scientific objectives and results to lead discussions, build alignment, and make recommendations.
• Ability to prioritize, manage team priorities/resources, and complete project deliverables within given timelines.
• Organized, detail oriented, and proficient in writing formal reports, documents, and technical presentations.
• Aptitude as a functional mentor/technical point of contact and ability to effectively train others.

Physical Demands

• The role is a combination of laboratory and office-based work.
• The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required.
• The role may require unassisted lifting (not to exceed 50 lbs.).

Work Environment

• Position is primarily laboratory and office based with occasional work in a classified GMP manufacturing environment.
• Dynamic, fast-paced, interactive, and entrepreneurial environment.
• Position is a team and project-based position that may require occasional shift work, weekends, and holidays.

Supervisory Responsibilities

May require supervisory responsibility of up to 3-5 direct reports. Demonstrated leadership experience is preferred.

Travel

<5% of travel required for this position.

Target Bonus

10%

Work Location:

East Syracuse, NY