Manufacturing Associate II - cGMP Cell & Gene Therapy Job Description The Manufacturing Associate II supports day-to-day operations at a cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role focuses on executing manufacturing processes safely, accurately, and on schedule to help deliver life-saving treatments to patients, while maintaining high standards of cleanliness, documentation, and regulatory compliance. Responsibilities

+ Execute day-to-day manufacturing operations safely, on schedule, and right the first time to support timely delivery of therapies to patients.

+ Adhere to current Good Manufacturing Practices (cGMP) and standard operating procedures at all times during manufacturing activities.

+ Escalate manufacturing operations issues to quality assurance and leadership in a timely and appropriate manner.

+ Maintain production facilities in a clean, organized, and inspection-ready state, including cleanroom environments.

+ Perform routine equipment maintenance and calibrations as required to ensure reliable and compliant operation.

+ Complete and review GMP documentation, including batch records and logbooks, accurately and within required timeframes.

+ Maintain an appropriate and current level of training for all assigned responsibilities and processes.

+ Assist with inventory management of materials and supplies in the manufacturing facility to support uninterrupted operations.

+ Support daily tasks and manufacturing activities across the team, stepping in where needed to ensure operational continuity.

+ Collaborate effectively with cross-functional team members, offering assistance and responding positively to requests for help.

+ Use strong communication skills to build productive working relationships and promote a culture of teamwork.

+ Demonstrate technical acumen, operational understanding, and consistent GMP compliance in all activities.

+ Support operational excellence initiatives, including process improvements and standardization efforts.

+ Promote and support a culture of safety, quality, and compliance within the manufacturing environment.

+ Identify opportunities for continuous improvement in processes, documentation, and workflows.

+ Utilize quality management systems, including handling Deviations, CAPAs, and Change Management records.

+ Work with electronic systems such as Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) tools.

+ Apply knowledge of regulations for GMP manufacturing of drug substances, drug products, cellular and gene therapies, and viral vectors for clinical-phase therapies.

+ Contribute to the production of therapies with a proven focus on safety, accuracy, and first-time-right execution.

+ Support cell therapy manufacturing activities for cancer treatments.

+ Meet the physical requirements of the role, including visual confirmation of documentation and equipment parameters, and proper gowning procedures in cleanroom settings.

+ Participate in shift work, weekend coverage, and holiday work as needed to support timely delivery of autologous cell therapies.

+ Engage in learning, growth, and evolution of shift structures and processes to better support delivery of critical products to patients. Essential Skills

+ Minimum of 2 years of experience in GMP biopharmaceutical operations, preferably with exposure to cell therapy, mammalian cell culture, and/or microbial fermentation.

+ Proven track record in cGMP manufacturing operations, producing therapies safely and correctly on the first attempt.

+ Familiarity with regulations governing GMP manufacturing of drug substances, drug products, cellular and gene therapies, and viral vectors for clinical-phase therapies.

+ Experience with quality management systems, including handling Deviations, CAPAs, and Change Management.

+ Experience working with electronic systems such as Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems.

+ Ability to complete, review, and maintain accurate GMP documentation within required timelines.

+ Strong communication skills and ability to build effective relationships across teams.

+ Demonstrated technical acumen and operational understanding within a GMP manufacturing environment.

+ Ability to maintain a high level of cleanliness and organization in production facilities.

+ Capacity to meet physical requirements, including visual inspection of materials, product, and documentation, and performing gowning procedures.

+ Willingness and ability to work shifts, weekends, and holidays to support patient-focused manufacturing schedules.

+ Fast learner with adaptability and strong cross-collaboration skills. Additional Skills & Qualifications

+ Bachelor of Science degree in a relevant field such as biochemistry, chemical engineering, bioengineering, or a related scientific discipline.

+ Experience in cell therapy manufacturing and autologous cell therapy processes.

+ Experience in mammalian cell culture operations.

+ Experience in microbial fermentation processes.

+ Familiarity with operational excellence and continuous improvement methodologies.

+ Strong focus on safety and compliance in a regulated manufacturing environment.

+ Motivation to support cell therapy manufacturing for cancer and contribute to life-saving treatments.

+ Ability to adapt to evolving shift structures and operational needs in a clinical manufacturing setting. Work Environment This role is 100% onsite in a cGMP clinical manufacturing facility with cleanroom operations. Team members work in controlled environments that require comfort with full gowning procedures, including stepping over gowning benches and donning nonsterile and sterile gowns from head to toe. Work involves frequent visual confirmation of batch records, SOP steps, equipment parameters, and material status, as well as visual inspection of materials and product; use of corrective lenses is acceptable. The position includes shift work, weekend work, and holiday coverage to support timely delivery of autologous cell therapies to patients. The environment emphasizes safety, GMP compliance, cleanliness, and collaboration, with ongoing opportunities to learn, grow, and help refine shift structures and processes to better support the production of critical cancer therapies. Job Type & Location This is a Contract position based out of Bothell, WA. Pay and Benefits The pay range for this position is $30.00 - $35.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Bothell,WA.

Application Deadline This position is anticipated to close on Sep 18, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.