Manufacturing Associate

Description

• Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
• Support a culture of safety and GMP compliance.
• Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
• Maintain production facilities at a high standard of cleanliness and organization.
• Escalate manufacturing operations issues to management and quality assurance in a timely manner.
• Assist with daily tasks and support manufacturing. Collaborate Effectively
• Adhere to the current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs).
• Support operational excellence initiatives.
• Perform equipment maintenance and calibrations as required.
• Identify opportunities for continuous improvement.
• Maintain appropriate level of training for assigned responsibilities.
• Assist with inventory management of supplies in the manufacturing facility.
• Complete and review GMP documentation in a timely manner.
• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe nonsterile and sterile gowns.

Requirements

• Demonstrate technical acumen, operational understanding, and GMP compliance.
• A Minimum of 4 years’ experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
• Experience with electronic systems such as MES and ERP
• Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
• Be a team player, offer assistance, and respond well to requests for help from team members.
• Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
• Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
• Use strong communication and build relationships.
• Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.

Benefits

• Health Spending Account (HSA)
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Bothell,WA. Application Deadline This position is anticipated to close on Jan 20, 2026.
• Transportation benefits
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Short and long-term disability
• Employee Assistance Program
• Medical, dental & vision

Training + Development

Interview process

Visa Sponsorship

Security clearance