3 дня назад
Scientist, Analytical Sciences and Technology, Chemistry
109 200 - 174 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist, Analytical Sciences and Technology, Chemistry (Analytical Chemistry): Leading analytical method transfers, validations, troubleshooting, investigations, and lifecycle management for chemistry-based methods supporting pharmaceutical quality control and manufacturing, with an accent on HPLC/UPLC, GMP compliance, and cross-functional technical leadership. Focus on resolving OOS/OOT issues, analyzing complex scientific data, implementing CAPAs, and maintaining inspection-ready analytical documentation across internal and external laboratories.
Location: Norwood, Massachusetts, United States. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.
Salary: $109,200–$174,600 per year, with potential bonus, incentive compensation, or equity eligibility.
Company
develops mRNA technology and medicines through a biotechnology platform focused on transforming how medicines are created and delivered.
What you will do
- Lead and support chemistry-based analytical method transfers, validations, verifications, comparability assessments, and lifecycle management across internal and external laboratories.
- Provide technical expertise for HPLC/UPLC, chromatographic, compendial, and other chemistry-based analytical methods and instrumentation.
- Troubleshoot analytical issues affecting laboratories, manufacturing operations, and product disposition, identifying root causes and corrective actions.
- Support OOS, OOT, deviation, atypical-result, and laboratory investigations, including scientific data analysis and CAPA development.
- Author, review, and approve protocols, reports, methods, specifications, investigations, and SOPs while supporting regulatory submissions, inspections, and audits.
- Collaborate with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, CMOs, and contract testing laboratories to harmonize analytical practices and improve testing strategies.
Requirements
- Must be a U.S. person eligible to access export-controlled information; non-U.S. persons cannot be sponsored for an export control license.
- Bachelor’s degree in analytical chemistry, chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related discipline with 5+ years of relevant industry experience; or a master’s degree with 3+ years; or a PhD with 0–2 years.
- Experience with analytical method transfer, qualification, validation, verification, or lifecycle management in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
- Working knowledge of GMP regulations, data integrity principles, pharmaceutical quality systems, and laboratory investigations.
- Hands-on experience with HPLC/UPLC, chromatographic method execution, troubleshooting, data interpretation, and scientific trend analysis.
- Ability to author technical documents, solve complex analytical problems, and collaborate across Quality, Manufacturing, Regulatory, and external partner functions.
Nice to have
- Experience with ICH, USP, FDA, EMA, and other global health authority or compendial requirements.
- Experience leading CAPAs, deviation management, change controls, analytical control strategies, regulatory filings, or commercial manufacturing support.
- Experience with digital and data-driven analytical operations initiatives.
Culture & Benefits
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, mental health, and broader well-being resources.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
- Savings and investment programs plus location-specific benefits.
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