Manufacturing Associate

Actalent • Frederick, MD • 6h ago

Job Title: Manufacturing AssociateJob Description

Join our team as a Manufacturing Associate where you will play a vital role in executing manufacturing batch records and standard operating procedures (SOPs) for the production of clinical material in a GMP environment. Collaborate with the MSAT department to provide expert consultation on tech transfer activities and ensure compliance with cGMP standards and good documentation practices.

Responsibilities

Execute manufacturing batch records and standard operating procedures (SOPs) for clinical material production in a GMP environment.

Provide expert consultation on tech transfer activities to the MSAT department.

Understand the manufacturing process and equipment used for clinical material production.

Assess and resolve common problems during cell therapy production.

Comply with cGMP standards and good documentation practices, supporting internal site audits.

Undergo advanced training in SOPs and work instructions for cell therapy manufacturing and train others as needed.

Author and revise SOPs for cell therapy manufacturing.

Document Deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements.

Ensure supplies for manufacturing are replenished and prepared for the cleanroom.

Assist in ensuring a steady supply of materials by sourcing alternative products and suppliers.

Essential Skills

GMP and cleanroom experience.

Proficiency in Batch Record, Manufacturing, Cell Culture, Aseptic Processing, and Cell Therapy or Biologics.

Experience in GMP Production and GDP.

2+ years' experience in cGMP production of biologics, preferably cell therapy.

Excellent documentation skills for cGMP manufacturing.

Ability to apply critical thinking, independent decision-making, and troubleshooting skills.

Additional Skills & Qualifications

BS Degree in Life Sciences or Engineering.

Significant knowledge in biologics manufacturing, cell culture, and/or cell therapy production.

Sterile gowning and aseptic processing qualifications.

Work Environment

The position involves hands-on work with complex equipment in a cleanroom environment where safety, environmental, and health concerns are prioritized. Employees must adhere to strict company policies, rules, and regulations. The role requires handling biological materials in a cleanroom, wearing personal protective equipment including eye protection, mask, coverall gown, gloves, and shoe covers. It also involves extended periods of standing for up to 3-6 hours, ability to lift 30 lb., and occasional weekend and holiday work. The shift is Wednesday to Sunday from 8:30 am to 5 pm.

Job Type & Location

This is a Contract position based out of Frederick, MD.

Pay and Benefits

The pay range for this position is $31.25 - $43.00/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 Frederick,MD.

Application Deadline

This position is anticipated to close on Mar 23, 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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