1 день назад
Associate Manufacturing - Bulk Drug Substance Upstream - Days
70 985 - 96 038$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Manufacturing - Bulk Drug Substance Upstream - Days (Biotechnology Manufacturing): Supporting startup and routine operation of a new bulk drug substance manufacturing facility, including cell culture, perfusion, filtration, centrifugation, and electronic batch records with an accent on cGMP compliance, operational readiness, and equipment execution. Focus on commissioning and qualification, technology transfer, 24/7 manufacturing shifts, deviation documentation, and continuous improvement.
Location: Holly Springs, North Carolina, United States. The role requires onsite work, initially Monday–Friday from 8:00 a.m. to 5:00 p.m., transitioning to a 12-hour 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., including some holidays, inclement weather, and requested overtime.
Salary: $70,985.20–$96,038.80 annually.
Company
is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.
What you will do
- Support operational readiness, facility startup, commissioning, qualification, and early manufacturing execution.
- Perform cell culture manufacturing operations involving seed train, single-use bioreactors, perfusion, RTF, stainless-steel bioreactors, depth filtration, and centrifugation.
- Set up, operate, monitor, clean, and sanitize manufacturing equipment and assigned areas.
- Perform in-process sampling, operate analytical equipment, and complete electronic batch records.
- Document deviations and quality events, support investigations and corrective actions, and escalate issues affecting safety, quality, or schedule.
- Maintain clean, organized, safe, and compliant manufacturing areas while supporting continuous improvement.
Requirements
- High school diploma/GED plus 2 years of manufacturing or regulated-environment experience; or an associate’s degree plus 6 months of relevant experience; or a bachelor’s degree.
- Ability to follow cGMP procedures, SOPs, manufacturing procedures, job hazard analyses, and applicable regulations.
- Ability to consistently follow gowning and aseptic techniques.
- Ability to work assigned 12-hour shifts and support 24/7 manufacturing operations, including holidays and overtime when required.
- Ability to work effectively in a team-based manufacturing environment with strong verbal and written communication.
Nice to have
- NC BioWork or BioWorks Certification Program completion.
- Experience in biotechnology or pharmaceutical manufacturing.
- Basic understanding of cGMP manufacturing environments.
- Familiarity with EBR/MES, DeltaV, and electronic quality systems.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off and biannual company-wide shutdowns.
- Career development opportunities and support for professional and personal well-being.
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