1 день назад
Scientist, Analytical Sciences and Technology
109 200 - 174 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist, Analytical Sciences and Technology (Analytical Method Lifecycle Management): Supporting analytical method transfers, validations, investigations, and continuous improvement for commercial and late-stage pharmaceutical and vaccine programs with an accent on GMP compliance, method performance, and cross-functional technical leadership. Focus on troubleshooting analytical issues, analyzing OOS/OOT data, developing CAPAs, and ensuring inspection-ready documentation across internal laboratories, manufacturing operations, and external testing partners.
Location: Norwood, Massachusetts, United States; 70% in-office work model. Due to U.S. export control requirements, only U.S. persons are eligible, and non-U.S. persons cannot be sponsored for an export control license.
Salary: $109,200–$174,600 per year, with potential eligibility for an annual discretionary bonus, incentive compensation, or equity award.
Company
develops mRNA technology and medicines, including biologics and vaccines.
What you will do
- Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
- Provide technical leadership for analytical method performance monitoring, lifecycle management, and continuous improvement.
- Troubleshoot analytical issues affecting laboratory operations, manufacturing, and product disposition, including root-cause analysis and corrective actions.
- Support OOS, OOT, deviation, atypical-result, and laboratory investigations, using scientific data analysis to identify trends and risks.
- 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 compliant analytical execution and inspection readiness.
Requirements
- Bachelor’s degree in a relevant scientific discipline and 5+ years of industry experience, or a master’s degree and 3+ years, or a PhD and 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, and pharmaceutical quality systems.
- Experience authoring and reviewing technical documentation and supporting laboratory investigations.
- Ability to analyze scientific data, identify trends, solve technical problems, and collaborate across functions.
- Must qualify as a U.S. person under U.S. export control laws; visa sponsorship is not available for non-U.S. persons.
Nice to have
- Hands-on experience with chromatographic, spectroscopic, molecular, lipid-based, vaccine, biologics, or biochemical analytical techniques.
- Knowledge of ICH, USP, FDA, EMA, and other global health authority requirements.
- Experience with CAPAs, deviation management, change controls, analytical control strategies, and regulatory filing activities.
- Experience supporting CMOs, contract testing laboratories, or other third-party testing partners.
Culture & Benefits
- 70/30 work model emphasizing in-office collaboration, teamwork, innovation, and mentorship.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, mental health, family planning, 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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