Manufacturing Associate (Onsite)

POSITION SUMMARY

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.

PRIMARY RESPONSIBILITIES

• This position is responsible for performing a variety of manufacturing tasks under general guidance and in accordance with current GMPs.
• 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.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• 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.

Preferred:

• Experience in Fermentation/Upstream (microbial fermentations, filtration equipment) and/or Downstream experience (HPLC and low-pressure Chromatography)

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED
• 3 years of experience in a cGMP manufacturing environment or other comparable experience (i.e., other regulated industry)

Preferred:

• Associate degree, BA or BS in a science-related field or Engineering Field.

PTx is committed to the principles of pay equity and providing competitive compensation for all of our Partners. The current pay range for this position is $58,000 - $77,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.