2 дня назад
Scientist, Analytical Sciences and Technology, Chemistry (Biotechnology)
109 200 - 174 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist, Analytical Sciences and Technology, Chemistry (Biotechnology): Supporting analytical method lifecycle management for commercial and late-stage development programs with an accent on chemistry-based methods, HPLC/UPLC, validation, troubleshooting, and GMP compliance. Focus on investigating OOS/OOT results, analyzing analytical data, authoring inspection-ready documentation, and driving improvements across QC laboratories, manufacturing, and external testing partners.
Location: Norwood, Massachusetts, United States; U.S. persons only due to export-control requirements
Salary: $109,200–$174,600 per year, plus potential bonus, incentive compensation, or equity.
Company
develops mRNA-based therapeutics and vaccines through its technology platform, delivery technology, and manufacturing capabilities.
What you will do
- Lead and support chemistry-based analytical method transfers, validations, verifications, comparability assessments, and lifecycle management.
- Provide technical expertise for HPLC/UPLC, chromatographic methods, compendial testing, and analytical instrumentation.
- Troubleshoot analytical issues affecting laboratories, manufacturing, and product disposition, identifying root causes and corrective actions.
- Support OOS, OOT, deviation, atypical-result, and laboratory investigations through scientific data analysis.
- Author, review, and approve protocols, reports, methods, specifications, investigations, and SOPs.
- Collaborate with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, CMOs, and contract testing laboratories to support inspection readiness and network harmonization.
Requirements
- Bachelor’s degree with 5+ years, master’s degree with 3+ years, or PhD with 0–2 years of relevant industry experience in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline.
- Experience with analytical method transfer, qualification, validation, verification, or lifecycle management in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
- Experience authoring and reviewing technical documents and supporting laboratory investigations, including OOS and OOT assessments.
- Working knowledge of GMP regulations, data integrity principles, pharmaceutical quality systems, and scientific data analysis.
- Experience collaborating with Quality, Manufacturing, Regulatory Affairs, and external partners.
- Must qualify as a U.S. person under U.S. export-control laws; non-U.S. persons are not eligible and visa sponsorship is unavailable.
Nice to have
- Hands-on expertise with HPLC/UPLC, chromatographic method execution, troubleshooting, and data interpretation.
- Knowledge of ICH, USP, FDA, EMA, and other global health-authority requirements.
- Experience with CAPAs, deviation management, change controls, analytical control strategies, regulatory filings, or commercial manufacturing support.
Culture & Benefits
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental-health support.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
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