Manufacturing Associate (Onsite)

Partner Therapeutics•Lynnwood, WA

8d•$58,000 - $77,500•Onsite

About The Position

Manufacturing Associates are involved in cleaning and sterilization of process equipment, autoclaving, buffer and media preparation, aseptic processing, operating process equipment and supporting cGMP operations. Upstream staff focuses on managing and running fermenters and filtration equipment, Downstream staff focuses on HPLC and low-pressure Chromatography equipment. This position is an ONSITE role requiring an onsite presence 5 days per week at our Lynnwood, WA plant which is a cGMP production scale manufacturing facility for our product, Leukine® (sargramostim), a therapeutic glycoprotein.

Requirements

Ability and willingness to wear a respirator and other PPE for multiple consecutive hours while meeting compliance and safety guideline to complete certain tasks.
Ability and willingness to work with strong acids, bases, and other solvents required for the job (PPE utilized).
Effectively demonstrates an understanding of GMPs and strictly follows cGMP requirements and standards.
Possess problem solving skills
Utilize manufacturing knowledge to improve operations and affect positive change
Self-motivated and take initiative to complete tasks
Ability to be flexible with change
Solid English language skills, both verbal and written.
Ability to write clear and concise procedure documents; is able to clearly expresses ideas, opinions, and questions.
Proficiency with MS Office products, especially Microsoft Word.
High School Diploma or GED
3+ years of experience in a cGMP manufacturing environment or other comparable experience (i.e., other regulated industry)

Nice To Haves

Experience in Fermentation/Upstream (microbial fermentations, filtration equipment) and/or Downstream experience (HPLC and low-pressure Chromatography)
Associate degree, BA or BS in a science-related field or Engineering Field.

Responsibilities

Operates process equipment such as fermenters and chromatography systems in accordance with established Standard Operation Procedures (“SOP”s).
Operates support equipment such as autoclaves, media and buffer preparation equipment in accordance with established SOPs.
Performs clean-in-place and steam-in-place operations to prepare equipment for manufacturing operations in accordance with established SOPs.
Identifies and troubleshoots routine issues and defects with assistance from higher level co-workers or SMEs.
Performs routine maintenance on process equipment and systems.
Assists in the review and creation of SOPs and other operational documents.
Maintains fit and finish of process area.
Practices safe work habits and adheres to Partner’s safety procedures and guidelines.
May train new team members as appropriate.
Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
Successfully completes all mandatory Quality and Compliance training within required timeframes.

Benefits

medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage
casual, and Hybrid or Remote workplace program for many roles
pre-IPO options
annual cash bonuses
401k matching
free parking or Seattle-area ORCA pass
tuition assistance
rewards for achievement and contribution
gym subsidy
wellness participation programs
generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays