Manufacturing Associate I - Bothell WA
About The Position
The Manufacturing Associate I supports routine cell therapy manufacturing operations and contributes to cell therapy programs. The role requires a general understanding of Good Manufacturing Practices (GMPs), flexibility, teamwork, and consistent attention to safety, quality, and GMP compliance. The associate learns and performs manufacturing operations according to governing documents and electronic systems, completes required documentation and training, and escalates safety or compliance concerns. Work includes carrying out daily unit-operation schedules across shifts, working in controlled cleanroom environments, performing assigned aseptic processing, and maintaining environmental conditions through area disinfection. The associate also refines manufacturing techniques and authors technically sound operating procedures that support efficient, compliant operations.
Requirements
- High school diploma or equivalent combination of education and experience.
- 0–1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education.
- Demonstrated experience working on collaborative, results-oriented teams.
- Proficiency with common computer tools, including word processing, spreadsheets, and web-based applications.
- Meticulous attention to detail and personal accountability.
- Excellent interpersonal skills; attentive and approachable manner.
- Ability to maintain professional and productive relationships with area management and coworkers.
- Ability to stand and walk for extended periods.
- Ability to work in a cleanroom and perform assigned aseptic processing in ISO 5 biosafety cabinets while wearing required gowning and personal protective equipment.
- Ability to carry and/or lift up to 30 pounds several times a day and push and/or pull up to 50 pounds several times a day.
- Ability to work in areas that may contain strong magnets, in a BSL2/ML1 environment handling human blood components, and in areas with vapor-phase liquid nitrogen exposure.
- Ability to work an assigned day, evening, or night shift, including weekends and/or holidays.
Nice To Haves
- Associate or bachelor's degree in a related field.
- Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Responsibilities
- Learn and execute cell therapy manufacturing operations in compliance with applicable requirements.
- Perform operations according to governing documents, including SOPs, work instructions, batch records, and forms.
- Execute transactions and processes in electronic systems and follow business continuity processes.
- Prioritize personal and team safety, report safety events within 24 hours, and immediately escalate issues that may affect safety or compliance.
- Complete required documentation contemporaneously and in accordance with governing documents, safety policies, quality systems, GMP requirements, and ALCOA+.
- Complete assigned training by its due date and train to proficiency on process systems and supporting business systems.
- Execute the daily unit-operations schedule, supporting people, product, and material flow across multiple shifts.
- Work in a controlled cleanroom environment and perform assigned aseptic processing procedures.
- Maintain manufacturing environmental conditions, including particulate and viable microbial levels, by performing required area disinfection.
- Refine and improve manufacturing process techniques to improve individual operational times.
- Verify training completion before performing GxP tasks.
- Author manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
