Manufacturing Associate

TalentBurst, an Inc 5000 company; Bothell (WA); On-site; USD 44,083 - 49,593; Full time

Job summary

A leading manufacturing firm is seeking an Associate I, Manufacturing to join their clinical production team in Bothell, WA. This entry-level position requires a Bachelor’s degree and offers a salary range of $32.00 to $36.00 per hour. Responsibilities include supporting GMP operations, developing policies, and collaborating with various teams to ensure quality production. This role is ideal for motivated individuals interested in advancing their career in biopharmaceutical manufacturing.

Qualifications

• 0-2 years of experience in GMP biopharmaceutical manufacturing, preferably in cell therapy.
• Familiarity with quality management systems including handling deviations and CAPAs.
• Understanding of GMP regulations applicable to drug substances and gene therapies.

Responsibilities

• Support facility qualification and start-up activities.
• Develop and implement GMP procedures relevant to manufacturing operations.
• Maintain cleanliness and proper functioning of production facilities.

Skills

GMP biopharmaceutical manufacturing

Collaboration

Problem-solving

Adaptability

Education

Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or related scientific discipline

Job description

2 days ago Be among the first 25 applicants

TalentBurst, an Inc 5000 company provided pay range

This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$32.00/hr - $36.00/hr

Direct message the job poster from TalentBurst, an Inc 5000 company

Lead Recruiter | Service Delivery | Clinical and Scientific Division

Job Title: Associate I, Manufacturing

Location: Bothell WA

Duration: 12 Months

Possibility Of Extension: Yes

About Us:

We are a cutting-edge clinical manufacturing facility dedicated to producing plasmids, viral vectors, and autologous cell therapies under current Good Manufacturing Practices (cGMP). Our mission is to deliver life-saving therapies to patients, and we are seeking motivated individuals to join our dynamic team.

Position Summary:

The Clinical Manufacturing Associate will support operations within our cGMP clinical manufacturing site. This role will collaborate closely with Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer, execute, and optimize clinical manufacturing processes. The incumbent will be instrumental in establishing procedures for equipment use and manufacturing operations, ensuring compliance, quality, and safety in all aspects of production.

Key Responsibilities:

Facility Start-up and Operations

• Collaborate with MSAT, Quality, Process Sciences, and Vector Sciences teams to support facility qualification and start-up activities.
• Assist in developing operational frameworks for GMP cell therapy and viral vector manufacturing processes.

Manufacturing Process Execution

• Develop and implement GMP procedures and policies relevant to manufacturing operations.
• Execute manufacturing operations accurately, safely, and on schedule, ensuring “right the first time” delivery of therapies.
• Maintain cleanliness, organization, and proper functioning of production facilities, including equipment maintenance and calibrations.
• Complete and review GMP documentation in compliance with regulatory standards.
• Maintain training and competency for assigned tasks.

Technology Transfer and Capacity Building

• Work with Technical Operations teams to execute technology transfers and expand manufacturing capacity.
• Identify potential risks in manufacturing processes and implement mitigation strategies to safeguard product quality.

Collaboration and Continuous Improvement

• Foster strong communication and teamwork across all departments at the manufacturing site.
• Demonstrate technical proficiency, operational expertise, and GMP compliance.
• Support operational excellence initiatives and adoption of new technologies and systems.
• Promote a culture of safety, compliance, and quality.

Qualifications and Skills:

• Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or related scientific discipline.
• 0–2 years of experience in GMP biopharmaceutical manufacturing, preferably in cell therapy, mammalian cell culture, or microbial fermentation.
• Familiarity with quality management systems, including handling deviations, CAPAs, and change management.
• Understanding of GMP regulations applicable to drug substances, drug products, cellular and gene therapies, and viral vector manufacturing.
• Proven ability to perform cGMP manufacturing operations safely and effectively.
• Strong interpersonal skills, adaptability, and a fast learner with a collaborative mindset.
• Comfortable working in a fast-paced, start-up environment.

Physical Requirements:

• Ability to visually confirm documentation, equipment parameters, and perform visual inspections (corrective lenses acceptable).
• Ability to stand for extended periods and step over gowning benches (12-24”).
• Capable of aseptically donning full-body nonsterile and sterile gowns.

Work Schedule:

Due to the nature of autologous cell therapy production and patient treatment timelines, this position requires flexibility to work shifts, weekends, and holidays. We seek passionate, dedicated individuals willing to grow with our team and contribute to evolving shift structures that optimize product delivery.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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