Manufacturing Associate

Description

Responsibilities include, but are not limited to:

Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including: PBMC, media and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operations
Accurate and timely completion of documentation required by protocols, SOPs, and batch records
Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservation
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations
Assist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipment
Update and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements·
Routinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areas
Follow all cleaning and gowning procedures for the facility
Perform error free calculations of media component and cell concentration, dilution, viability during production
Must maintain and apply knowledge regarding donor information, screening and testing, labeling and product acceptability and release criteria
Be flexible and adaptable to schedule and procedural changes to ensure timely preparation of products with highest quality
Maintain current inventory of supplies kept in specified kitting and staging areas and CAR-T suites
Other duties as assigned

Position Requirements & Experience:

Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing
Aseptic processing in Grade A biosafety cabinets and Grade B clean rooms
Cell culture processing experience in handling and propagation of human primary cells is strongly preferred
Universal precautions for handling human derived materials in BSL-2 containment areas
Knowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapy
Excellent interpersonal, oral and written communication skills
Strong technical writing ability is strongly preferred
Ability to work off-shift and long hours as required
Frequent use of a computer monitor, keyboard and mouse required
Frequent lifting, carrying, pushing or pulling up to 30 pounds required
Frequent periods of sitting, walking, and standing required
Frequent use of personal protective equipment required
Occasional climbing stairs or ladders, bending or stooping, crouching or squatting required
Occasional fine finger dexterity/ including grasping or pinching required
Occasional use of hazardous materials and chemicals required
Occasional work in cold rooms and freezers required
Color, vision, and depth perception required for inspection or test related jobs.
Candidates must be authorized to work in the U.S.
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
Ability to work independently and as part of a team.
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
Candidates must be authorized to work in the U.S.

Skills

media preparation, GMP, Aseptic technique, Laboratory

Top Skills Details

media preparation,GMP,Aseptic technique

Experience Level

Entry Level

Job Type & Location
This is a Contract position based out of Newark, CA.
Pay and Benefits
The pay range for this position is $26.00 - $38.00/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 Newark,CA.
Application Deadline
This position is anticipated to close on Sep 30, 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 [email protected] 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.