Job Title: Downstream Gene Therapy Manufacturing LeadJob Description
The Downstream Gene Therapy Manufacturing Lead plays a key role in establishing internal GMP bulk drug substance (BDS) and final drug product (FDP) clinical and commercial AAV gene therapy manufacturing capability in Rockville, MD. As part of a highly engaged, collaborative Manufacturing Value Stream team, this role leads the start-up of an agile, multi-product, single-use facility and performs manufacturing process tasks and unit operations across upstream, downstream, and fill finish areas, with a primary focus on downstream operations.
Responsibilities
Lead downstream manufacturing activities for AAV gene therapy products within a GMP environment, ensuring safe, compliant, and efficient operations.
Help establish internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability, focusing on downstream and purification processes.
Participate in and support an ALL stream manufacturing environment by collaborating across media and buffer preparation, upstream, downstream, and fill finish areas.
Embody core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.
Support and maintain a safety-first culture that emphasizes individual accountability, safe systems of work, and visible management commitment.
Partner closely with Quality to maintain a robust quality and compliance culture that meets applicable GMP regulatory standards and supports successful regulatory inspections.
Execute and support operational readiness activities for a new internal manufacturing facility, including developing manufacturing procedures and standard practices, and supporting facility start-up, commissioning, and equipment and automation qualification.
Serve in a lead role for process technology transfers, including contributing to process documentation and leading the establishment of batch records.
Coordinate daily manufacturing operations, leading Gene Therapy Manufacturing (GTM) personnel to complete production activities safely and compliantly in accordance with OSHA and cGMP guidelines.
Act as a subject matter expert and qualified trainer for GMP manufacturing operations, processes, and equipment in upstream, downstream, and/or fill finish areas.
Deliver on-the-job training, facilitate meetings, and coach team members to build cross-functional skills across different manufacturing streams.
Lead root cause analysis for manufacturing events of minor to moderate scope, working with cross-functional stakeholders to identify causes and implement effective corrective and preventive actions.
Author, revise, and review GMP documentation such as standard operating procedures (SOPs), batch records, and other controlled documents to support compliant operations.
Support and apply GMP quality systems, including managing deviations and change controls within the quality management system (QMS).
Perform downstream unit operations such as depth filtration, tangential flow filtration (TFF), chromatography, solution preparation, and purification activities in a cleanroom and aseptic environment.
Contribute to continuous improvement and operational excellence initiatives to optimize manufacturing processes, enhance efficiency, and strengthen compliance.
Collaborate effectively with colleagues across manufacturing, quality, and other functions in a results-driven, team-oriented environment.
Maintain and expand personal training competency in an evolving manufacturing facility, proactively learning new processes, equipment, and technologies.
Support or lead projects related to facility start-up, commissioning, and qualification of single-use mixers and other single-use technologies and systems.
Travel up to approximately 5% of the time as needed to support manufacturing or technical transfer activities.
Essential Skills
Bachelors degree, or Associates degree/High School Diploma or equivalent with relevant cGMP manufacturing experience.
46 years of cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations; if 4 years of experience, all must be in downstream and purification.
Hands-on experience in downstream manufacturing operations, including purification, depth filtration, tangential flow filtration, chromatography, and solution preparation.
Strong experience working in GMP cleanroom and aseptic manufacturing environments.
Demonstrated experience with GMP quality systems, including deviation management and root cause analysis tools.
Proficiency in authoring, revising, and reviewing GMP documentation such as SOPs and batch records.
Excellent oral and written communication skills, with strong technical writing ability.
Strong organizational and leadership skills, including experience managing people or projects in a manufacturing setting.
Effective teaching and facilitation skills for delivering on-the-job training.
Ability to apply continuous improvement and operational excellence strategies within a manufacturing organization.
Ability to think critically for problem solving and troubleshooting in complex manufacturing processes.
Ability to work collaboratively in a results-driven, team-oriented environment.
Additional Skills & Qualifications
Subject matter expertise in GMP manufacturing operations, processes, and equipment for upstream, downstream, and/or fill finish areas.
Experience in aseptic fill finish operations and AAV manufacturing, including viral transfection.
Experience supporting facility start-up, commissioning, and qualification activities for GMP manufacturing facilities.
Hands-on experience with single-use technologies and systems, including single-use mixers.
Experience working with gene therapy products, biologics, AAV platforms, and related manufacturing processes.
Familiarity with quality management systems (QMS), deviations, and change control processes.
Experience facilitating meetings and leading cross-functional discussions in a manufacturing environment.
Ability to serve as a subject matter expert and qualified trainer for most GMP manufacturing operations.
Exposure to OSHA guidelines and their application in GMP manufacturing environments.
College education beyond a high school diploma is preferred to support strong critical thinking skills.
Work Environment
This role operates in both office and GMP manufacturing environments, including cleanroom and aseptic production areas. The position is based in Rockville, MD and is part of a highly engaged, collaborative Manufacturing Operations Value Stream team. The facility is an agile, multi-product, single-use site focused on gene therapy manufacturing, utilizing technologies such as depth filtration, tangential flow filtration, chromatography systems, single-use mixers, and other single-use equipment. Work is performed under cGMP and OSHA guidelines, with a strong emphasis on safety, quality, and compliance. Team members follow appropriate GMP and cleanroom attire requirements and personal protective equipment standards while working in production areas. The culture emphasizes a safety-first mindset, clear communication, strong relationships, and cross-functional development across media and buffer preparation, upstream, downstream, and fill finish operations. Limited travel of up to approximately 5% may be required.
Job Type & Location
This is a Contract position based out of ROCKVILLE, MD.
Pay and Benefits
The pay range for this position is $46.64 - $57.69/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
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)
Job Type & Location
This is a Contract position based out of ROCKVILLE, MD.
Application Deadline
This position is anticipated to close on Nov 6, 2026.
Workplace Type
This is a fully onsite position in ROCKVILLE,MD.
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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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.
