• Manufacturing Specialist, Gene Therapy

    Actalent (Rockville, MD)


    Job Title: Manufacturing SpecialistJob Description

     

    Join a dynamic Gene Therapy company as a Downstream Manufacturing Specialist in Rockville, MD. This role offers the opportunity to work in an 'ALL' stream environment that fosters cross-functional development across media/buffer preparation, upstream, downstream, and fill finish areas.

    Responsibilities

    + Embody core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.

    + Support and maintain a safety-first culture emphasizing individual accountability and management commitment.

    + Partner with Quality to uphold a robust quality and compliance culture that meets GMP regulatory standards and supports regulatory inspections.

    + Execute and support operational readiness activities for the new internal manufacturing facility, including establishing manufacturing procedures and standard practices, and commissioning and qualifying equipment and automation.

    + Review, revise, and author GMP documentation.

    + Achieve training competency in an expanding manufacturing facility.

    + Perform as a qualified trainer for assigned GMP manufacturing operations, processes, and equipment.

    + Analyze root causes for manufacturing events and assist with investigations.

    + Lead projects of minor to moderate scope with cross-functional stakeholder support.

    + Lead continuous improvement projects within the functional area.

    Essential Skills

    + GMP, Manufacturing, Cleanroom, Aseptic, Downstream, Depth Filtration, Tangential Flow Filtration, Chromatography, Solution prep, purification.

    + Experience in GMP quality systems and/or manufacturing operations, processes, and equipment for US, DS, and/or FF areas.

    + Experience with AAV manufacturing/viral transfection.

    + Supporting facility start-up, commissioning, and qualification activities.

    + Hands-on experience with single-use technologies and systems.

    + Strong oral and written communication skills.

    + Good teaching and facilitation skills for on-the-job training delivery.

    Additional Skills & Qualifications

    + Bachelor’s degree or Associate’s degree/High School Diploma with relevant cGMP experience.

    + 2-4 years of cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations.

    + Preference for purification experience.

    + Experience with cell culture, recovery, purification, bulk formulation, and fill finish.

    Work Environment

    This role operates in both an office and GMP environment. The position involves assembly creation, autoclaving, cleaning equipment and materials, and supporting upstream and downstream BDS manufacturing processes, including BSC aseptic operations, setting up equipment for processes, and making media. The work includes editing SOPs and collaborating with cell culture, recovery, purification, bulk formulation, and fill finish.

     

    Job Type & Location

     

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

    Pay and Benefits

    The pay range for this position is $35.00 - $38.00/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 ROCKVILLE,MD.

     

    Application Deadline

     

    This position is anticipated to close on Dec 2, 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.