Description
The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role will work closely with the Process Sciences, Vector Sciences, and Manufacturing Sciences and Technology (MSAT) teams to transfer and execute clinical manufacturing processes, and establish procedures for equipment and manufacturing operations.
KEY ROLE AND RESPONSIBILITIES:
Startup Facility and Operations
Work collaboratively with the MSAT, Quality, Process Sciences and Vector Sciences on all aspects of facility qualification and start-up.
Support the development of the operating paradigm for GMP cell therapy and viral vector manufacturing operations. Execute the Day-to-Day Manufacturing Processing
Assist in development and implementation of GMP procedures and policies related to Manufacturing Operations.
Execute manufacturing operations safely, as scheduled, and right the first time for delivery of treatment to patients.
Maintain production facilities at a high standard of cleanliness and organization, perform equipment maintenance and calibrations as required, and complete and review GMP documentation in a timely manner.
Maintain appropriate level of training for assigned responsibilities.
Work with TechOps teams to execute technology transfers and capacity building projects.
Identify and mitigate risks in the manufacturing areas that could negatively impact the quality of patient therapies.
Collaborate Effectively
Use strong communication and teamwork skills to build relationships across the manufacturing site.
Demonstrate technical acumen, operational understanding, and GMP compliance in managing the manufacturing operations.
Support operational excellence initiatives, and the implementation of new technologies and systems.
Ensure a strong culture in safety and GMP compliance
Additional Skills & Qualifications
0 - 2 years of experience in GMP biopharmaceutical operations preferably with experience in cell therapy, mammalian cell culture, and/or microbial fermentation.
Experience with quality management systems (e.g. Deviations, CAPAs, Change Management).
BSc degree in a relevant field (eg biochemistry, chemical engineering, bioengineering, or related scientific field)
KNOWLEDGE, SKILLS AND ABILITIES:
Familiar with regulations for GMP manufacturing of drug substance, drug products, cellular and gene therapies, and viral vectors for clinical phase therapies.
Proven track record in cGMP manufacturing operations, including producing therapies safely and right the first time.
Fast learner, adaptable, and excellent cross-collaboration and inter-personal skills.
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:
Confirm visual information in the environment such as batch record and SOP steps were completed properly, parameters on equipment and computer screens, status of materials and equipment, and perform visual inspection of materials and product. A vision test may be required. Use of corrective lenses is acceptable.
Stand and step over a gowning bench (12-24") and aseptically don head-to-toe nonsterile and sterile gowns
SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work, and holiday work will be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.
Job Type & Location
This is a Contract position based out of Bothell, WA.
Pay and Benefits
The pay range for this position is $36.00 - $36.00/hr.
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 Jun 5, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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.
