Senior GMP Technician

Job Description

Job Description

Job Title: SR. GMP Technician

Job Description

The Sr. GMP Technician leads and executes complex downstream manufacturing operations for gene therapy products in a cGMP-regulated environment. This role focuses on chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation, ensuring processes run efficiently, safely, and in full compliance with regulatory and internal quality standards. The Sr. GMP Technician independently operates and troubleshoots advanced downstream equipment, performs in-process testing, drives process improvements, and provides mentorship and training to junior team members while collaborating closely with quality and cross-functional teams.

Responsibilities

• Lead and execute downstream manufacturing operations, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, in accordance with Standard Operating Procedures (SOPs) and batch records.
• Independently prepare, operate, and troubleshoot advanced downstream equipment such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems to ensure optimal performance and compliance.
• Monitor critical process parameters during manufacturing operations, analyze process data, and proactively identify and address deviations or abnormalities, ensuring timely reporting, investigation, and resolution.
• Perform in-process testing and quality control checks, including pH, conductivity, and pressure measurements, as well as other analytical techniques, to confirm product quality and adherence to specifications.
• Accurately document all manufacturing activities, data, and results in accordance with cGMP regulations, SOPs, batch records, and internal policies, maintaining complete and compliant records.
• Collaborate closely with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents while maintaining regulatory compliance and meeting production timelines.
• Drive process improvements by evaluating new technologies, equipment, and methods, and lead the implementation of strategies that enhance manufacturing efficiency, productivity, and compliance.
• Mentor and train junior team members by providing guidance on process execution, equipment operation, troubleshooting, and adherence to cGMP guidelines and safety protocols.
• Ensure strict adherence to safety procedures and environmental health and safety guidelines, promoting and maintaining a safe and compliant working environment.
• Stay current with advancements in gene therapy downstream manufacturing processes, evolving regulatory requirements, and industry trends, and actively contribute ideas and expertise to continuous improvement initiatives.

Essential Skills

• Bachelors degree in Biology, Biochemistry, Biomedical Engineering, or a related life science field, or equivalent experience.
• Prior experience working in a GxP or other regulated manufacturing or laboratory environment.
• Hands-on downstream processing or biologics manufacturing experience, with a strong focus on gene therapy or similar biologics.
• Extensive expertise with downstream processing techniques and equipment, including chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems.
• Proficiency in conducting in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
• Excellent attention to detail and proven ability to accurately document and record experimental data and manufacturing activities in accordance with cGMP standards.
• Strong organizational skills with the ability to manage multiple tasks simultaneously, prioritize effectively, and meet project and production timelines in a fast-paced environment.
• Commitment to following SOPs, safety protocols, cGMP, and regulatory guidelines to ensure compliance and consistent product quality.
• Demonstrated leadership abilities, including experience mentoring and training junior team members in technical operations and compliance practices.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

Additional Skills & Qualifications

• Exp. in cleanroom operations and biologics manufacturing processes.
• Experience working with gene therapy downstream processes and viral vector formulation.
• Familiarity with electronic quality and documentation systems, such as Veeva, or similar platforms.
• Ability to collaborate effectively with QA, QC, and cross-functional teams to support investigations, process improvements, and production planning.
• Strong analytical and problem-solving skills, with the ability to interpret process data and propose corrective and preventive actions.
• Effective communication skills, both written and verbal, to convey technical information and training content clearly.
• Adaptability and comfort working in a growing, state-of-the-art facility that operates in a dynamic, start-up style environment.

Work Environment

This role is based in a growing, state-of-the-art gene therapy manufacturing facility that is still in an early, start-up phase, offering opportunities to shape processes and contribute to continuous improvement. There are two openings: one on first shift (approximately 7:00 a.m. to 3:30 p.m.) and one on second shift (approximately 2:00 p.m. to 10:30 p.m.), and both require flexibility to adjust hours in line with manufacturing needs. The position is performed in a temperature-controlled laboratory or office environment and involves regular standing, hand manipulation, and routine use of laboratory and downstream processing equipment. The role may require lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Work takes place in controlled environments, including cleanrooms, where appropriate personal protective equipment (PPE) must be worn when handling chemicals, biological materials, or operating equipment. The facility emphasizes safety, compliance, and collaboration, providing a professional setting focused on innovation in biologics and gene therapy manufacturing.

This is a Contract to Hire position based out of Grove City, OH.

The pay range for this position is $37.00 - $38.00/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)

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

This position is anticipated to close on Oct 15, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.