Job Title: Downstream Manufacturing SpecialistJob Description
This role offers an opportunity to join a gene therapy manufacturing team in Rockville, MD as a Downstream Manufacturing Specialist. You will help establish the first internal GMP bulk drug substance (BDS) and finished drug product (FDP) clinical and commercial AAV gene therapy manufacturing capability in an agile, multi-product, single-use facility. The position sits within a highly engaged and collaborative Manufacturing Operations Value Stream and focuses on downstream operations while providing exposure to media and buffer preparation, upstream processing, and fill finish activities.
Responsibilities
Work in an integrated "all-stream" manufacturing environment that supports cross-functional development across media and buffer preparation, upstream, downstream, and fill finish operations.
Embody core values by collaborating effectively, building strong working relationships, and communicating clearly to meet shared manufacturing objectives.
Support and maintain a safety-first culture by demonstrating individual accountability, following safe systems of work, and reinforcing management commitment to safety.
Partner with Quality to sustain a robust quality and compliance culture that meets applicable GMP regulatory standards and supports successful regulatory inspections.
Follow standard practices, procedures, and batch records to perform and verify downstream process tasks and unit operations such as depth filtration, tangential flow filtration, chromatography, solution preparation, and purification.
Execute and support operational readiness activities for a new internal manufacturing facility, including the establishment of manufacturing procedures and standard practices.
Contribute to facility start-up efforts, including commissioning and qualification of equipment, single-use systems, and automation platforms.
Proactively build and maintain training competency across an expanding manufacturing facility, including downstream and related operations.
Apply company policies and procedures to identify routine production issues, escalate them appropriately, and support their resolution in alignment with GMP expectations.
Support manufacturing operations for biologics, pharmaceuticals, and vaccines, including activities related to cell culture, recovery, purification, bulk formulation, and fill finish as needed.
Participate in and support GMP quality system activities, including documentation, batch record review support, deviations, change control, and other QMS processes.
Contribute to continuous improvement of processes, procedures, and ways of working in a dynamic, multi-product gene therapy manufacturing environment.
Essential Skills
Bachelor's degree, or Associate's degree, or High School Diploma (or equivalent) with relevant cGMP experience.
0-2+ years of cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations.
Foundational experience in one or more of the following areas: cell culture, recovery, purification, bulk formulation, and/or fill finish operations.
Experience working in a GMP manufacturing environment, including adherence to batch records and standard operating procedures.
Ability to work collaboratively in a results-driven, team-oriented environment.
Understanding of downstream manufacturing operations, including purification processes.
Familiarity with GMP, cleanroom operations, and aseptic techniques.
Experience with downstream unit operations such as depth filtration, tangential flow filtration, chromatography, solution preparation, and purification.
Exposure to gene therapy, biologics, or vaccine manufacturing processes.
Ability to follow and support GMP documentation practices, including batch records and quality system processes.
Additional Skills & Qualifications
Good oral and written communication skills to support clear documentation and effective collaboration.
Good teaching and facilitation skills for delivering on-the-job training to colleagues.
Experience in GMP quality systems, including working with deviations, change control, and other QMS elements.
Experience with manufacturing operations, processes, and equipment in upstream, downstream, and/or fill finish areas.
Experience with AAV manufacturing and/or viral transfection processes.
Experience supporting facility start-up, including commissioning and qualification activities for equipment and systems.
Hands-on experience with single-use technologies and systems in a manufacturing environment.
Experience using a process control system (PCS) to operate and monitor automated equipment.
Demonstrated high level of performance, reliability, and accountability in prior roles.
Familiarity with single-use mixers and related single-use equipment.
Experience working with gene therapy products, AAV vectors, and associated purification processes.
Comfort working with batch records and other GMP documentation in a regulated environment.
Work Environment
This role operates in both office and GMP manufacturing environments. You will work in a cleanroom setting that follows strict GMP, cleanroom, and aseptic practices, including the use of appropriate gowning and personal protective equipment. The facility is an agile, multi-product, single-use gene therapy manufacturing site that supports bulk drug substance and finished drug product operations for AAV-based therapies. You will regularly interact with single-use mixers, downstream processing equipment such as depth filters, tangential flow filtration systems, chromatography skids, and process control systems. The work involves close collaboration with cross-functional teams in manufacturing, quality, and engineering, and requires consistent adherence to safety, quality, and regulatory standards.
Job Type & Location
This is a Contract position based out of ROCKVILLE, MD.
Pay and Benefits
The pay range for this position is $28.00 - $36.00/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.
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 process due to a disability, please email actalentaccommodation@actalentservices.com 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.
