Downstream Manufacturing Specialist, Gene Therapy

Actalent • Rockville, MD • 2h ago

Job Title: Downstream Manufacturing SpecialistJob Description

Join a dynamic Gene Therapy company in Rockville, MD as a Downstream Manufacturing Specialist. This role offers a unique opportunity to work in an 'ALL' stream environment, allowing for cross-functional development across media/buffer prep, upstream (US), downstream (DS), and fill finish (FF) manufacturing areas.

Responsibilities

Embody core values by collaborating effectively, building strong relationships, and using clear communication to meet shared objectives.

Support and maintain a safety-first culture, emphasizing individual accountability and safe systems of work.

Partner with Quality to maintain a robust quality and compliance culture that meets applicable GMP regulatory standards.

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/or author GMP documentation.

Achieve training competency in an expanding manufacturing facility.

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

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

Lead continuous improvement projects within the functional area.

Essential Skills

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

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

Good oral and written communication skills.

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

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

Experience with AAV manufacturing/viral transfection.

Experience in supporting facility start-up, commissioning, and qualification activities.

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

Additional Skills & Qualifications

Bachelor's degree or Associate's degree/High School Diploma or equivalent with relevant cGMP experience.

Preference for purification experience.

Experience using QMS systems.

Demonstration of a high level of performance.

Work Environment

The role operates within both an office and GMP environment. This opportunity involves working with cutting-edge single-use technologies and systems. The position demands adherence to GMP standards and protocols, ensuring a high level of safety and compliance. Dress code aligns with GMP standards.

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 May 21, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

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