Quality Scientist II

Job Title:

Quality Scientist II Job Description The Quality Scientist II works within the Quality Department to support the testing and analysis of cGMP-produced viral vectors and cells. This role operates in a regulated GMP laboratory environment, performing and developing QC methods, supporting microbiological environmental monitoring, and maintaining high standards of documentation and compliance for cellular and gene therapy products. The position collaborates closely with senior QC staff to help shape and implement strategic direction for the GMP area and contributes directly to the production of phase-appropriate clinical materials. Responsibilities Perform QC laboratory testing on cGMP-produced viral vectors and cells using techniques such as PCR, qPCR, ddPCR, gel electrophoresis, pH measurements, and related molecular biology assays. Support the development, optimization, and qualification of QC methods and assays under the guidance of senior staff. Analyze microbiological environmental monitoring samples and document results in accordance with established procedures. Write, review, and revise Standard Operating Procedures (SOPs) to ensure they accurately reflect current laboratory practices and regulatory expectations. Perform routine equipment maintenance, monitoring, and basic troubleshooting to ensure laboratory instruments remain in a qualified and reliable state. Manage materials and supplies for QC and Production, including tracking inventory, coordinating replenishment, and ensuring appropriate storage and handling. Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the controlled manufacturing facility. Ensure all product samples are accurately labeled and that sample allocation, handling, and transfer are fully documented in the appropriate formats and systems. Maintain full accountability for product samples as they are distributed across different testing requirements and storage conditions. Evaluate processes related to sample management, identify gaps or inefficiencies, and implement improvements to enhance quality and throughput. Complete, review, file, and archive documentation according to SOPs and applicable regulatory requirements. Maintain compliance with regulatory requirements for cellular and gene therapy products through adherence to GMP, data integrity, and documentation standards. Perform daily work in accordance with established policies, procedures, and techniques, applying training and working knowledge to complete assigned tasks. Collaborate effectively in a diverse and team-oriented environment, using clear communication to support high productivity and shared goals. Document all activities performed in accordance with quality and regulatory expectations, ensuring accuracy, completeness, and traceability. Essential Skills Bachelor's degree (BS) in Biology or another relevant scientific discipline. Prior GMP laboratory experience, including familiarity with regulated documentation and quality systems. Hands-on experience performing molecular biology assays such as PCR, qPCR, and gel electrophoresis. Experience with assay execution and exposure to assay development activities. Strong understanding of regulatory and documentation requirements in a GMP environment, including data integrity and audit readiness. Ability to write, review, and follow SOPs and other controlled documents. Competence with basic laboratory techniques such as dilutions and pH measurements. Ability to work under close supervision while applying training and working knowledge to complete tasks accurately and efficiently. Strong attention to detail and organizational skills for sample management and documentation. Effective communication skills and the ability to work collaboratively within a cross-functional team. Additional Skills & Qualifications Experience working with cellular and gene therapy products or other biologics in a GMP setting. Background in microbiology or environmental monitoring in a regulated facility. Experience contributing to method development or optimization in a QC environment. Familiarity with quality management systems supporting clinical or commercial manufacturing. Ability to identify process gaps in sample or materials management and propose practical improvements. Comfort working in a growing, dynamic organization with opportunities for internal advancement. Work Environment The role is based in a new, state-of-the-art GMP facility with modern laboratories and equipment dedicated to the manufacture and testing of phase-appropriate materials, including viral vectors and cell-based products. The work environment is highly team-oriented, with close collaboration among a group of approximately 10-12 colleagues on each shift. The position is scheduled on first shift, Monday through Friday, generally from 8:00 a.m. to 4:30 p.m., with some flexibility as needed. The setting emphasizes strong communication, mutual support, and a culture that promotes growth and internal advancement. Dress code is business casual, appropriate for a professional laboratory environment. Job Type & Location This is a Contract to Hire position based out of Dublin, OH. Pay and Benefits The pay range for this position is $28.00 - $28.00/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 Dublin,OH.

Application Deadline This position is anticipated to close on May 22, 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.