5 дней назад
Principal Research Associate, Analytical Science & Technology (Biotech)
89 900 - 143 800$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Research Associate, Analytical Science & Technology (Biotech): Supporting analytical CMC activities for late-phase development and commercial programs with an accent on method validation, transfer, lifecycle management, and regulatory documentation. Focus on coordinating internal and external laboratories, preparing technical documentation, resolving data package gaps, and maintaining traceability within GMP-regulated quality systems.
Location: Norwood, Massachusetts, United States; 70% in-office work model. Only U.S. persons eligible due to U.S. export control requirements; cannot sponsor non-U.S. persons for an export control license.
Salary: $89,900–$143,800 per year, with potential annual bonus, other incentive compensation, or equity award.
Company
develops mRNA medicines and operates a technology platform focused on transforming how medicines are created and delivered.
What you will do
- Coordinate analytical method activities across late-phase development and commercial programs, maintaining timelines, trackers, action logs, and status updates.
- Support analytical method validation, transfer, verification, and lifecycle management planning and execution.
- Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams.
- Author and revise validation plans, protocols, reports, transfer documents, method summaries, technical memos, and gap assessments.
- Compile analytical documentation and data packages for regulatory submissions, health authority responses, post-approval commitments, and commercial readiness.
- Maintain traceable records, support meetings and follow-up, and escalate risks or delays within regulated quality systems.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
- At least 3 years of experience in Analytical Development, Quality Control, Analytical Sciences, or a related biopharmaceutical function.
- Experience with analytical method qualification, validation, transfer, or lifecycle management in a GMP-regulated environment.
- Working knowledge of analytical documentation for late-phase or commercial regulatory submissions, ICH guidelines, and GMP regulations.
- Strong technical writing, documentation, organization, communication, and cross-functional collaboration skills.
- Must qualify as a U.S. person under U.S. export control laws.
Nice to have
- Experience with biologics, vaccines, or other complex modalities.
- Experience supporting validation protocols, reports, method transfer documentation, or regulatory submissions.
- Experience with external laboratories, CDMOs, or global manufacturing and testing networks.
- Ability to manage multiple priorities in a fast-paced environment.
Culture & Benefits
- In-person collaboration supported by a 70/30 work model.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning benefits, including fertility, adoption, and surrogacy support.
- Paid time off, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs plus location-specific benefits.
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