8 дней назад
Manufacturing Associate II (Biopharma)
63 200 - 100 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Associate II (Biopharma): Performing formulation, sterile filtration, aseptic filling, and visual inspection for drug product operations with an accent on cGMP compliance, aseptic processing, and accurate electronic batch-record documentation. Focus on executing 12-hour night-shift manufacturing operations, investigating deviations, maintaining equipment and materials readiness, and supporting continuous improvement in a cleanroom environment.
Location: Norwood, Massachusetts, United States; onsite 12-hour night shift from 6:00 PM to 6:00 AM. Only U.S. persons eligible due to U.S. export-control requirements.
Salary: $63,200–$100,900 per year, with potential discretionary bonus, incentive compensation, or equity.
Company
develops mRNA medicines and operates a biotechnology platform focused on changing how medicines are created and delivered.
What you will do
- Perform formulation, sterile filtration, vial and syringe filling, and downstream visual inspection in accordance with SOPs and cGMP requirements.
- Prepare materials and components, perform equipment checks, aseptic line clearances, cleaning, and routine in-process controls.
- Complete contemporaneous ALCOA+ documentation in logbooks, MES, and electronic batch records.
- Identify and escalate deviations, atypical events, and equipment issues while supporting troubleshooting and investigations.
- Contribute to SOP and work-instruction updates, continuous improvement, cross-training, and peer mentoring.
- Collaborate with QA, QC, MS&T, Facilities, Supply Chain, and other functions during operations and issue resolution.
Requirements
- Associate or bachelor's degree in a scientific field, or a high school diploma with equivalent experience.
- Two to four years of GMP manufacturing or a similar experience is preferred; strong entry-level candidates may be trained.
- Ability to work in cleanrooms with full gowning, stand for extended periods, and lift approximately 35 pounds.
- Basic computer skills, including batch records and training systems, plus reliable and detail-oriented execution.
- 20/20 vision is required, with corrected vision accepted; the ability to see all colors across the visible spectrum is required and will be tested at hiring and annually.
- Availability for a 12-hour night shift from 6:00 PM to 6:00 AM, including weekends, holidays, overtime, and operational coverage as needed; U.S. person status is required.
Culture & Benefits
- Healthcare coverage and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning benefits covering fertility, adoption, and surrogacy.
- Paid time off including vacation, volunteer days, sabbatical, global recharge days, and a year-end shutdown.
- Savings and investment programs, plus location-specific benefits.
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