Manufacturing Associate

Position Title: Manufacturing Associate

Work Location: Bothell, WA

Assignment Duration: 12 Months

Work Schedule: Sunday-Tuesday 11:00 AM-11:30 PM alternating Wednesday

Work Arrangement: 100% Onsite

Position Summary:

Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Key Responsibilities:

* Learn and execute Cell Therapy Manufacturing operations compliantly

* Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)

* Executes transactions and process in all electronic systems and adheres to business continuity processes

* Prioritizes safety of self and others

* Reports safety events within 24 hours

* Immediately escalates any/all issues that may impact compliance or safety of self and/or others.

* Complete documentation required by Source Governing Documents contemporaneously

* Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+

* Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge.

* Train for proficiency in process systems and some supporting business systems

* Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts

* Work within a control cleanroom environment and execute aseptic processing procedures (as assigned)

* Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements

* Continues to refine and improve manufacturing process technique to improve individual operational times.

* Verifies training completion prior to performing any GxP tasks

* Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements

Qualification & Experience:

* Associate or bachelor's degree in related field is preferred

* A minimum high school diploma and/or equivalent combination of education and experience is required

* 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education

* Proven experience working on teams where collaboration and results were expected

* Proficiency in common computer tools such as word processing, spreadsheet and web-based applications

* Meticulous attention to detail and personal accountability is critical to success

* Possess excellent interpersonal skills, is attentive and approachable

* Maintain a professional and productive relationship with area management and co-workers

* Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred

Working Conditions & Physical Demands (If Applicable):

* Must be able to stand/walk for extended periods of time

* Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection

* Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials

* Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials

* Work in areas that may have strong magnets

* Must be able to work in a BSL2 / ML1 work environment handling human blood components

* Work in areas with exposure to vapor phase liquid nitrogen

* Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)

Additional Information (If Applicable):

Position Handles Hazardous Materials