12 дней назад
Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days (Biotechnology Manufacturing): Supporting drug substance manufacturing startup and operations through material weighing, buffer and media preparation, equipment operation, and cGMP documentation with an accent on aseptic processing, operational readiness, and facility commissioning. Focus on preparing the new facility for production, operating critical equipment, completing electronic batch records, and supporting 24/7 manufacturing execution.
Location: Holly Springs, North Carolina, United States; onsite role with regular attendance required
Company
is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Support the ANC2 facility expansion, startup, commissioning, qualification, and operational readiness program.
- Weigh and dispense raw materials and prepare, transfer, and handle buffers, media, and solutions.
- Set up, clean, sanitize, monitor, and operate manufacturing equipment, including washroom and autoclave activities.
- Perform in-process sampling, operate analytical equipment, and complete electronic batch records and equipment logs.
- Follow cGMP, safety, gowning, aseptic processing, SOP, and manufacturing procedure requirements.
- Collaborate with QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, and Regulatory teams.
Requirements
- High school diploma/GED plus 2 years of manufacturing or regulated-environment experience; or an associate degree plus 6 months of relevant experience; or a bachelor's degree.
- Ability to work onsite, including assigned 12-hour shifts, holidays, inclement weather, and requested overtime.
- Experience or understanding of cGMP manufacturing in a regulated industry such as biotechnology or pharmaceuticals.
- Ability to follow aseptic techniques, safety requirements, procedures, and production schedules.
- Strong verbal and written communication skills, with proficiency in Microsoft Office and electronic manufacturing systems.
- Availability to work Monday through Friday during startup, transitioning to a 12-hour 2-2-3 schedule from 5:45 a.m. to 6:15 p.m.
Nice to have
- NC BioWork Certificate Program completion.
- Experience with EBR/MES, Delta V, and electronic quality systems.
- Demonstrated motivation to learn and develop knowledge of operations and processes.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time off plans and biannual company-wide shutdowns.
- Career development opportunities and work-life balance programs.
- No relocation assistance is provided.
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