8 дней назад
Scientist II, QC Analytical (Biotech)
124 000 - 165 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist II, QC Analytical (Biotech): Performing GMP-compliant analytical quality control testing for raw materials, in-process samples, drug substances, water, and final drug products with an accent on analytical methods, documentation, and laboratory systems. Focus on reviewing test data, investigating OOS/OOT results and deviations, validating equipment and methods, and maintaining regulatory compliance.
Location: Framingham, United States; 5-day on-site expectation
Salary: $124,000–$165,500 annual base pay, plus performance incentive bonus and equity eligibility
Company
develops oncolytic immunotherapies designed to stimulate local and systemic anti-tumor responses for cancer treatment.
What you will do
- Perform analytical QC testing of raw materials, in-process samples, water, drug substance, and final drug products according to SOPs and cGMP requirements.
- Establish, revise, and maintain QC analytical procedures and laboratory systems.
- Review testing data and GMP documentation completed by analysts.
- Generate protocols and reports for QC method qualifications and support equipment validation.
- Manage change controls, deviations, CAPAs, OOS/OOT events, and laboratory investigations.
- Coordinate sample storage, retention inventory, contract laboratory shipments, audits, and regulatory inspections.
Requirements
- BA or BS in analytical chemistry or a related science, preferably with chemistry coursework.
- 5+ years of experience in a GMP/GLP or similar environment.
- Knowledge of analytical techniques and practical experience in an analytical laboratory.
- Understanding of USP/EP monograph testing and requirements.
- Computer literacy with MS Word and Excel, strong communication and organizational skills.
- Ability to work independently and collaboratively in a team.
Culture & Benefits
- Collaborative, bold, dedicated, and candid working principles.
- Medical, dental, and vision insurance.
- 401(k) match and flexible time off.
- Paid holidays, including a year-end shutdown.
- Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity opportunities.
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