Job Description:

POSITION SUMMARY:

The incumbent is responsible for establishing the QC release testing of immunotherapy products with a focus on cell-based test methods. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs). This role will serve as a key member of the QC team and will partner closely with the Analytical Development (AD) and Manufacturing teams for training, transferring test methods, and releasing drug product.

Shift for Position: Wednesday - Saturday from 7:00 am - 5:30 pm

KEY ROLE AND RESPONSIBILITIES:

Work cross-functionally with AD in the transfer and qualification of the cell-based test methodsPerforming Environmental Monitoring and/or Sample ManagementPerform routine in-process and release testing of cell therapy productsMaintenance of human cell linesCreation of test method transfer and validation protocolsAuthoring of test methods and supporting Standard Operating Procedures (SOPs) for the QC LaboratoriesMaintain critical reagents inventory and qualification for QC labsPerforming routine preventative maintenance on QC equipment

Qualifications:

PREFERRED EDUCATION:

BSc degree with 2-5 years’ experience in a relevant field (eg Immunology, Cell Biology)MSc degree with 1-3 years’ experience in a relevant field (eg Immunology, Cell Biology)

PREFERRED EXPERIENCE:

A minimum of 2 years of cell-based testing within a regulated cGMP environmentExperience with environmental monitoring and sample managementExperience in lab build-up is a plusQuality systems experience in managing deviations, CAPAs

KNOWLEDGE, SKILLS AND ABILITIES:

Execution of method validation in a commercial facilityGood Documentation Practices (GDP) and ALCOA requiredGood organizational and time management skillsGood oral and written communication for effective interpersonal collaborationAbility to work in a team environment and perform job responsibilities with reasonable supervisionExceptional attention to detailIdentify opportunities for operational excellence, application of Lean principles and continuous improvementMust be proactive, action oriented and have the ability to adapt to a changeExperience with real-time PCR, FCS Express (Flow) and/or cell-based assays and passaging is a plus.Experience in a technical role within a GMP biopharmaceutical manufacturing operation*

Pay and Benefits

The pay range for this position is $33.00 - $37.00/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 Feb 13, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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.