Principal Scientist, Analytical Development – Drug Substance
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Job Description
Principal Scientist leading analytical development for drug substances in a biotech company. Collaborates with cross-functional teams and ensures regulatory compliance in drug development processes.
Responsibilities:
- Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Experienced with a wide range of techniques such as HPLC, GC, LC-MS, NMR, UV, FTIR, and other relevant analytical techniques to ensure method suitability for intended applications.
- Design and lead method validation activities to ensure methods meet ICH, FDA, EMA, and other applicable regulatory guidelines. Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
- Prepare, review, and approve technical documents such as standard operating procedures (SOPs), analytical study methods/protocols/reports, and product specifications.
- Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
- Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
- Lead or contribute to multi-disciplinary project teams, manage analytical development timelines and communicate progress to stakeholders.
Requirements:
- PhD. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field with 5+ years of relevant industry experience; or M.S. with 7+ years; or B.S with 10+ years.
- Experience with analytical development in the pharmaceutical, biotechnology or CRO/CMO industry including direct experience with regulatory submissions and GMP/GLP environments.
- Direct experience working with external manufacturing and analytical/quality sites is essential.
- Proficiency in chromatographic (HPLC, UPLC, GC), spectroscopic (MS, UV/Vis, FTIR), and other analytical techniques. Experience with method development, validation, transfer, and troubleshooting is essential.
- Experience with late phase development activities (registration/PPQ) is a plus.
- Comprehensive understanding of ICH, FDA, EMA, and other health authority guidelines relevant to analytical method development and validation.
- Excellent written and verbal communication skills, with the ability to present complex scientific data to diverse audiences and write clear, concise technical documents.
- Capacity to manage multiple workflows and priorities in a fast-paced, evolving environment.
Benefits:
- Annual bonus opportunity
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- AD&D insurance
- Short term disability
- Long term disability
- 401(K) plan with match
- Stock options
- Flexible non-accrual paid time off
- Parental leave
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