Senior Scientist, Analytical R&D
About The Position
The Senior Scientist, Analytical R&D independently develops, optimizes, troubleshoots, qualifies, and validates analytical methods for large and small molecule characterization. Relevant techniques include liquid chromatography (SEC, RP, IEX, HIC), mass spectrometry (including TOF, QTOF, and SEC-MS), icIEF/cIEF, and capillary electrophoresis. The role works across internal departments and with external resources, supporting analytical research, regulatory requirements, and company SOPs. As a subject matter expert, the scientist plans and leads analytical project work, supports bio-conjugation and development activities, and communicates scientific findings and project progress to clients and stakeholders. The position also contributes to laboratory process and quality-system improvements while maintaining safety and compliance standards.
Requirements
- Hands-on experience and deep knowledge in analytical method development, optimization, troubleshooting, qualification, and validation using techniques such as LC (SEC, RP, IEX, HIC), mass spectrometry (TOF, QTOF, SEC-MS), icIEF, and capillary electrophoresis.
- Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related area with 2–4 years of experience; alternatively, a master's degree in chemistry or a related field with 5–7 years of experience.
- At least 1 year of GMP experience.
- Proven industry experience and a track record in analytical method development, project leadership, and problem solving in the pharmaceutical or biotechnology industry.
- Ability to independently and collaboratively develop and execute analytical methods and author and review methods, protocols, and reports.
- Ability to manage multiple projects simultaneously and prioritize changing responsibilities and deadlines.
- Strong communication skills, including the ability to communicate scientific data through presentations, protocols, test methods, and reports to internal and external audiences.
- Ability to work independently and collaboratively with internal and external team members.
- Strong analytical thinking, problem-solving, planning, organization, and time-management skills.
- Proficiency with Microsoft Office.
- Ability to work outside normal business hours, including occasional nights, weekends, or holidays, as needed.
Nice To Haves
- Experience with antibody-drug conjugate (ADC) development and bioconjugates.
- LC/MS method development for characterization of monoclonal antibodies, ADCs, and oligo-antibody conjugates.
- Experience with control strategies for large-molecule drug substances and drug products and phase-appropriate national and international regulatory filing strategies.
Responsibilities
- Independently develop, optimize, troubleshoot, qualify, and validate analytical methods for chromatography, mass spectrometry, icIEF/cIEF, capillary electrophoresis, and other characterization techniques.
- Plan project responsibilities as an analytical-method subject matter expert, execute work against timelines, and lead scientific discussions in client meetings.
- Troubleshoot complex analytical problems involving chromatography, mass spectrometry, sample preparation, instrument performance, and column variability.
- Author and review analytical test methods, protocols, reports, and other documents.
- Review and interpret analytical data, chromatograms, spectra, calculations, and laboratory notebooks for scientific accuracy, data integrity, and compliance.
- Contribute to continuous improvement of laboratory processes, analytical procedures, documentation practices, and quality systems.
- Prepare and present project status and progress updates to clients.
- Stay abreast of current scientific literature.
- Liaise with purchasing regarding arrivals and assist procurement with material selection.
- Support assay troubleshooting, investigations, analytical method improvement, interpretation of complex data, and statistical analysis using appropriate software.
- Support analytical methods for bio-conjugation, process development, product development, in-process monitoring, and stability studies for APIs, drug substances, and bioconjugates.
- Promote laboratory best practices, project management, communication, and safe work practices; comply with company EHS, quality, regulatory, and policy requirements.
- Perform other tasks and assignments as specified by management.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
