13 дней назад
Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)
86 048 - 116 417$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions) (Biotechnology Manufacturing): Coordinating new product introduction activities at a biologics drug substance manufacturing plant with an accent on quality risk assessments, process bills of materials, and change control records. Focus on aligning cross-functional manufacturing, quality, supply chain, MES, and single-use systems requirements while maintaining inspection-ready documentation and tracking implementation deliverables.
Location: Holly Springs, North Carolina, United States
Annual salary: USD 86,048.05–116,417.95
Company
is a biotechnology company developing treatments and operating advanced biologics drug substance manufacturing facilities.
What you will do
- Coordinate New Product Introduction programs for the North Carolina biologics drug substance manufacturing plant.
- Facilitate cross-functional Quality Risk Assessments and maintain QRA reports, FMEAs, risk action logs, and supporting records.
- Create and maintain process Bills of Materials and coordinate input, review, reconciliation, and material readiness across stakeholders.
- Own assigned NPI Change Control records, including impact assessments, implementation planning, lifecycle tracking, and closure.
- Track dependencies, due dates, deliverables, and objective evidence while escalating risks and delays.
- Provide readiness updates and communicate complex issues across Manufacturing, Quality, Process Development, Supply Chain, MES, and Single-Use Systems.
Requirements
- Master’s degree; or a bachelor’s degree with 4 years of Manufacturing or Operations experience; or an associate’s degree with 8 years; or a high school diploma/GED with 10 years.
- Experience in GMP manufacturing or manufacturing support, preferably in biotechnology or pharmaceutical manufacturing.
- Experience with Quality Risk Assessments, FMEAs, change controls, continuous improvement records, deviations, CAPAs, or related quality-system activities.
- Experience creating or maintaining manufacturing Bills of Materials and coordinating material readiness across functions.
- Knowledge of drug substance manufacturing, process requirements, electronic batch records, or MES.
- Strong cross-functional coordination, meeting facilitation, technical writing, compliant documentation, prioritization, and communication skills.
Nice to have
- Degree in Science, Engineering, Supply Chain, Operations, or a related field.
- Experience with Veeva QMS or TrackWise.
- Experience working independently in a matrix environment and escalating risks promptly.
Culture & Benefits
- Full-time employment with health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plans with company contributions.
- Annual discretionary bonus and stock-based long-term incentives.
- Paid time off and bi-annual company-wide shutdowns.
- Flexible work models, including remote arrangements where possible, alongside career development opportunities.
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