GMP Lead (Downstream)

Actalent; Grove City (OH); On-site; USD 93,000 - 100,000; Full time

Benefits offered by this job

5 weeks paid time off

Etna Benefits

14 paid company holidays

Job summary

Actalent is seeking a GMP Lead (Downstream) to oversee a team responsible for purification of viral vectors in a cGMP cleanroom. The role emphasizes process optimization, tech transfer, and documentation aligned with GMP regulations.

The ideal candidate will have 4+ years in downstream GMP manufacturing, hands-on chromatography/TFF experience, and a proactive, collaborative approach to cross-functional teams in a state-of-the-art facility in Grove City, OH.

Qualifications

• 4+ years of relevant experience in downstream GMP manufacturing.
• Experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography.
• Proficiency in purification processes, such as chromatography, filtration, and centrifugation.
• Working knowledge of cGMP requirements and biological drug development.
• Self-motivating, organized, and proactive.
• Ability to work the hours necessary to support production and/or product transfer activities.
• Ability to work in loud noise environments and in PPE.

Responsibilities

• Lead downstream operations for purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.
• Plan and manage downstream activities, process optimization, and technology transfer to cGMP for viral vectors.
• Demonstrate proficiency on equipment associated with downstream processes, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.
• Complete and review documentation concurrently with completion of manufacturing processes.
• Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.
• Compile data with minimal oversight to author reports and analyze results for client-facing summaries.
• Collaborate with Quality Systems, including QA and QC, to satisfy GMP regulations and guidances.
• Train and mentor junior technicians; perform periodic review of direct reports.
• Report unexpected issues by initiating deviations, participating in investigations, determining root-cause, and implementing CAPA.
• Partner with the Technical Writing team to draft, revise, and review GMP documentation.

Skills

Downstream GMP

Chromatography

TFF

PPE experience

Education

BS or MS in relevant field

Tools

Single-use technologies

Job description

Job Title: GMP Lead (Downstream)

Job Description

The GMP Lead (Downstream) will manage a team of technicians responsible for implementing and performing downstream operations, ensuring the successful purification of viral vectors according to client specifications. This role requires technical problem-solving skills and expertise in laboratory techniques to support growth in the Gene Therapy sector.

Responsibilities

• Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.
• Plan and manage downstream activities, process optimization, and technology transfer to cGMP for viral vectors.
• Demonstrate proficiency on equipment associated with downstream processes, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.
• Complete and review documentation concurrently with completion of manufacturing processes.
• Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.
• Compile data with minimal oversight to author reports and analyze results for client-facing summaries.
• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.
• Train and mentor junior technicians; perform periodic review of direct reports.
• Report unexpected issues by initiating deviations, participating in investigations, determining root-cause, and implementing CAPA.
• Partner with the Technical Writing team to draft, revise, and review GMP documentation.

Essential Skills

• 4+ years of relevant experience in downstream GMP manufacturing.
• Experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography.
• Proficiency in purification processes, such as chromatography, filtration, and centrifugation.
• Working knowledge of cGMP requirements and biological drug development.
• Self-motivating, organized, and proactive.
• Ability to work the hours necessary to support production and/or product transfer activities.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE).

Additional Skills & Qualifications

• Relevant BS or MS degrees preferred.
• Experience with gene therapy manufacturing.
• Proficiency in using single-use technologies within a GMP downstream processing environment.
• Working knowledge of aseptic techniques and automated systems.

Work Environment

The role will spend approximately 70% of the time in the cleanroom and 30% at a desk collaborating with cross-functional teams. The work schedule is from 2 PM to 10:30 PM, Monday through Friday, with some flexibility and an expectation of roughly 5 hours of overtime per week. The environment is dynamic, offering a new state-of-the-art facility with opportunities for upward mobility.

Job Type & Location

This is a Permanent position based out of Grove City, OH.

Pay And Benefits

The pay range for this position is $93000.00 - $100000.00/yr.

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.

• 5 week paid time off Etna Benefits 14 paid company holidays

Workplace Type

This is a fully onsite position in Grove City,OH.

Application Deadline

This position is anticipated to close on Sep 11, 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 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 [e-mail] 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.