Duties and Responsibilities
- Learn and execute Cell Therapy Manufacturing operations compliantly.
- Execute operations as outlined in Source Governing Documents (including SOPs, work instructions, batch records, forms).
- Perform transactions and processes in electronic systems and adhere to business continuity processes.
- Prioritize safety of self and others; report safety events within 24 hours.
- Immediately escalate any issues impacting compliance or safety.
- Complete required documentation contemporaneously.
- Perform tasks in accordance with safety policies, SOPs, quality systems, and GMP requirements (including ALCOA+).
- Complete training assignments prior to assigned due dates.
- Train for proficiency in process systems and some supporting business systems.
- Execute the daily unit operations schedule (people, product, and material flow across multiple shifts).
- Work in a control cleanroom environment and execute aseptic processing procedures (as assigned).
- Maintain manufacturing environmental conditions by performing area disinfection regimens per controlled area specifications and global Health Authority requirements.
- Refine and improve manufacturing process techniques to improve operational times.
- Verify training completion prior to performing any GxP tasks.
- Author manufacturing operating procedures that are technically sound, promote efficient operations, and comply with cGMP requirements.
Education
- Associate or bachelor’s degree in related field preferred.
- Minimum high school diploma and/or equivalent education and experience required.
Experience / Qualifications
- 0–1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience/education.
- Experience working on collaborative teams.
- Proficiency with common computer tools (word processing, spreadsheets, web-based applications).
- Meticulous attention to detail and personal accountability.
- Excellent interpersonal skills.
- Professional, productive relationship with area management and coworkers.
- Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing preferred.
Working Conditions / Requirements
- Stand/walk for extended periods.
- Work in cleanroom; perform aseptic processing in ISO 5 biosafety cabinets (as assigned) with required gowning and PPE.
- Lift/carry up to 30 lb (15 kg) several times/day; push/pull up to 50 lb (25 kg) several times/day.
- Work around strong magnets; BSL2/ML1 environment handling human blood components.
- Exposure to vapor phase liquid nitrogen.
- Work assigned shift (Day/Evening/Night, weekends and/or holidays).
- Shifts: Days Sun–Tue (alt. Wed) 0500–1730; Days Thu–Sat (alt. Wed) 0500–1730; Swing Sun–Tue (alt. Wed) 1100–2330; Swing Thu–Sat (alt. Wed) 1100–2330.
Compensation and Benefits (as stated)
- Bothell, WA: $30.61–$37.09 per hour (full-time FTE basis).
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k), short-/long-term disability, life and accident insurance, supplemental health, business travel/personal liability protection, identity theft benefit, legal support, survivor support.
- Paid Time Off (flexible time off for US exempt; vacation/holidays for certain groups) and additional time off may be available based on eligibility.
Application Instructions
- Apply if the role interests you even if your resume doesn’t perfectly match.