• Upstream Manufacturing Associate

    Actalent (Rockville, MD)


    Description

    Summary

    The manufacturing associate works within the manufacturing department and will provide hands-on technical support for all aspects of cGMP cell therapy manufacturing, including technology transfer, process validation, and process support. The manufacturing associate will work in both team-oriented and individual environments. S/he will assist in monitoring process performance at the contract manufacturing organization (CMO) and ensure successful delivery of products with regard to time, quality, and budget. The manufacturing associate is expected to be self-motivated to complete assigned tasks and communicate results to their supervisor in a timely manner.

     

    1. Responsibilities Manufacturing

    + Review and monitor cell culture and aseptic processing activities performed at CDMOs

    + Review and monitor GMP developmental and commercial manufacturing operations

    + Provide Quality Assurance (QA) with technical support for process discrepancies and deviation investigations

    + Plan and track domestic and international GMP and non-GMP material shipments.

    + Assist in planning, writing, and managing the execution of cGMP manufacturing protocols, batch records, SOPs/WIs, and plans

    + Prepare manufacturing/campaign reports

    + Accountable for the integrity and tracking of cGMP manufacturing department process data.

    + Accurately and timely manage the tracking of all cGMP material and cell bank inventories

    + Coordinate and track lot release testing samples.

    + Assist with technical support for CDMO GMP manufacturing activities

    + Maintain cGMP cell bank and product inventories

    2. General Responsibilities:

    + Liaise with functional groups and sub-contractors

    + Reports progress to supervisors and attend progress meeting regularly.

    + Must be familiar with aseptic processing techniques in a cleanroom.

    + Maintains a familiarity with current and emerging technologies through reading and understanding scientific and technical literature

    + Complies with quality systems and all pertinent safety policies, rules and regulations.

     

    Additional Skills & Qualifications

    Requirements

    + BS or MS degree in Biology or related discipline.

    + Understanding in cell and molecular biology technique for the identification and validation of drug targets.

    + 2-5 years of biotechnology, pharmaceutical cGMP manufacturing experience

    + cGMP aseptic processing and tissue culture using Flask, HyperStack, Cell Factory, and 3D cell culture experience preferred

    + Strong interpersonal, attention to detail, communication, and organizational skills

    + Good documentation (GDP) and organizing skills are recommended.

    + Self-directed and self-motivated: demonstrate ability to work both independently and as a team member in a matrix environment.

    + Exceptional oral and written English communication skills

    Pay and Benefits

    The pay range for this position is $70000.00 - $80000.00/yr.

     

    • 401(k)• 401(k) matching• Dental insurance• Flexible schedule• Health insurance• Life insurance• Paid time off• Referral program• Vision insurance

     

    Workplace Type

     

    This is a fully onsite position in Rockville,MD.

     

    Application Deadline

     

    This position is anticipated to close on Jun 12, 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.

     

    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 [email protected] (%[email protected]) for other accommodation options.