Manufacturing Associate - Biopharma

ASK Consulting; Bothell (WA); On-site; USD 42,000 - 65,000; Full time

Job summary

ASK Consulting in Bothell, WA is seeking a Manufacturing Associate to support production in a cellular therapeutic manufacturing environment. The role emphasizes precise, timely completion of tasks and strict GMP adherence within a cleanroom setting.

Ideal candidates hold a life sciences degree or associates with related experience and have 0–2 years of cGMP manufacturing exposure. Local residency required; shift options include day or night schedules.

Qualifications

• Bachelor's or Associates in life sciences preferred; high school diploma with related experience accepted.
• 0-2 years of cGMP manufacturing experience desired.
• Proficiency with common office software and web-based tools; strong attention to detail and accountability.

Responsibilities

• Perform routine manufacturing tasks per written procedures and recognize deviations.
• Adhere to GMPs and standard operating procedures (SOPs).
• Weigh and verify raw materials; assemble, clean and sanitize equipment; monitor processes.
• Maintain cleanroom conditions to regulatory standards and complete work instructions.
• Train for proficiency on primary production equipment and process systems (e.g., Syncade MES, Oracle interfaces).
• Assist in revising process documents and SOPs; support inventory management.
• Support a safe work environment and collaborate with cross-functional manufacturing teams.
• Share batch information across teams and resolve routine production issues.

Skills

cGMP experience

Regulatory controlled environments

Attention to detail

Education

Bachelor's degree in Life Sciences

Job description

Job title: Manufacturing Associate - Biopharma

Location: Bothell, WA (Must be local, no relocation offered)

Contract

2 Shifts Open:

Shift #1: Days - Sun, Mon, Tue & alt Wed, 0500am - 530pm, Every Thu/Fri/Sat OFF

Shift #2: Nights - Wed, Thu, Fri & Alt Sat, 500pm-530am, every Sun/Mon/Tue OFF

Job Description:

*Top Skills:

• Bachelor's degree in Life Sciences Degree is preferred
• Experience in regulatory controlled environments
• cGMP experience

Position Summary

The primary purpose of the Manufacturing Associate role is to complete production assignments with high quality and timely output in a cellular therapeutic manufacturing environment.

Duties/Responsibilities

• Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Weighs and checks raw materials. Assembles, cleans and sanitizes process equipment, monitors processes.
• Completes work instructions and maintains clean room environment to comply with regulatory requirements.
• Trains for proficiency in the operation of primary production equipment within the assigned functional area.
• Trains for proficiency in process systems (i.e. Syncade MES and Oracle interfaces) and some supporting business systems (i.e. Oracle, ETQ, BMRAM etc.).
• Assist with the revision and or creation of process documents, such as SOPs and electronic work instructions.
• Assists in maintaining material and components inventory level.
• Supports safe work environment.
• Work in teams and have continual interaction with members of his/her team as well as other
• manufacturing teams throughout the production process in order to exchange information regarding the batch(s) in process.
• Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.

Qualifications

• Associates or Bachelors degree in life sciences field is preferred. Minimum of high school diploma and/or equivalent combination of education and experience is required.
• 0-2 years of cGMP manufacturing experience is desired or equivalent in work experience or education. Proven experience working on teams where combined contribution, collaboration, and results were expected.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications. Experience where attention to detail and personal accountability were critical to success.
• Demonstrates good interpersonal skills, is attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers

Physical Requirements

• Must be able to stand/walk for extended periods of time
• Must be able to work in a cleanroom environment and perform aseptic processing, 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