URGENTLY HIRING: GMP Scientist II

Actalent; Columbus (OH); Presencial; USD 32 000 - 45 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision insurance

401(k) Retirement Plan

Life Insurance

Resumo da oferta

Actalent is seeking a GMP Operations Senior Scientist in Columbus, OH, focused on fill/finish for biological products and cell/gene therapy materials. You will lead GMP production activities, manage timelines, coordinate personnel, and ensure compliant, cost‑effective manufacturing with strong documentation.

The role requires hands‑on leadership, adherence to batch records and SOPs, and collaboration with GMP management to drive improvements and maintain high quality standards.

Qualificações

• Four‑year degree in life sciences or Master’s preferred.
• 3 years of relevant GMP/bioprocessing experience with a four‑year degree, or 1 year with a Master’s.
• Experience with cell culture, mammalian systems, aseptic technique, and SOPs.

Responsabilidades

• Lead daily GMP manufacturing operations for biological products.
• Guide staff on batch records, SOPs, and QMS alignment.
• Plan and execute work to meet production goals with minimal supervision.
• Maintain accurate, timely GMP documentation and data.
• Collaborate with GMP management on continuous improvement initiatives.

Conhecimentos

Life sciences background

GMP knowledge

Bioprocessing operations

Cell culture experience

Documentation & SOPs

Project management

Communication skills

Team leadership

MS Office proficiency

Formação académica

Bachelor’s or Master’s in life sciences

Descrição da oferta de emprego

Job Description

The GMP Operations Senior Scientist guides all aspects of Good Manufacturing Practices (GMP) and production in a Clinical Manufacturing Facility, with a focus on fill/finish operations for biological products and cell and gene therapy materials. This role provides hands-on support and leadership for day-to-day GMP production activities, including project timeline management, personnel coordination, and operational planning. The Senior Scientist ensures products are manufactured in a timely, compliant, and cost-effective manner by training and leading staff, enforcing adherence to batch records and Standard Operating Procedures (SOPs), and maintaining high standards of documentation, quality, and professional conduct.

GMP Scientist II (Fill/Finish)

The GMP Operations Senior Scientist guides all aspects of Good Manufacturing Practices (GMP) and production in a Clinical Manufacturing Facility, with a focus on fill/finish operations for biological products and cell and gene therapy materials. This role provides hands-on support and leadership for day-to-day GMP production activities, including project timeline management, personnel coordination, and operational planning. The Senior Scientist ensures products are manufactured in a timely, compliant, and cost-effective manner by training and leading staff, enforcing adherence to batch records and Standard Operating Procedures (SOPs), and maintaining high standards of documentation, quality, and professional conduct.

Responsibilities

• Lead and support daily GMP manufacturing operations for biological products, including fill/finish processes, ensuring materials and documentation are in place to meet production goals.
• Provide hands‑on leadership on the production floor, guiding staff through manufacturing activities in alignment with batch records, SOPs, and the Quality Management System.
• Assign tasks to junior staff, solve problems, correct issues, and implement preventive actions as directed by leadership while exercising discretion, judgment, and personal responsibility.
• Plan and execute work to meet specific measurable objectives with minimal direct supervision, using strong operational planning skills.
• Set and maintain a professional standard within the GMP area, modeling high integrity, attention to detail, and a positive attitude.
• Collaborate closely with GMP Management to enact the strategic direction of the GMP operations area and support continuous improvement initiatives.
• Support GMP resources and the supply chain by ordering materials, maintaining inventory, and ensuring supplies are available to meet production timelines.
• Maintain a high standard of accurate, timely documentation for all GMP operations, ensuring all activities are recorded according to SOPs and regulatory requirements.
• Train and supervise junior staff on proper operation of facility equipment and on accurate documentation practices related to GMP activities and product quality.
• Work with GMP Management and Quality Assurance to guide operations staff in deviation investigations, out-of-specification (OOS) results, and process troubleshooting.
• Collaborate with GMP Management to identify, evaluate, and incorporate new projects and technologies into the GMP area.
• Respond to alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility and take appropriate action.
• Operate within the Quality Management System applicable to the manufacture of phase‑appropriate material in the Clinical Manufacturing Facility.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products and ensure manufacturing activities align with these standards.
• Lead and support a diverse and collaborative team environment, using clear and concise communication to drive high productivity and team success.
• Ensure all activities are performed in alignment with established policies, procedures, and techniques, applying relevant training, practical experience, and working knowledge.
• Demonstrate strong technical writing skills by contributing to SOP documentation and reports as needed.
• Consistently apply aseptic techniques and best practices in cell culture and microbiology during manufacturing operations.
• Contribute to the identification and tracking of metrics and other statistical measures to support continuous improvement and operational excellence.

Essential Skills

• Relevant four‑year Life Science degree or Masters degree.
• 3 years of relevant experience with a four‑year degree, or 1 year of relevant experience with a Masters degree.
• BG in life sciences, biotechnology, or gene therapy industries preferred.
• Prior experience in a GMP or GLP setting strongly preferred.
• Strong knowledge of GMP principles and bioprocessing operations.
• Experience with cell culture, tissue culture, and mammalian or eukaryotic systems.
• Proficiency in aseptic technique and microbiology practices in a laboratory or manufacturing environment.
• Experience with mammalian cell culture and cell‑based assay development.
• Excellent communication, organization, and project management skills, with the ability to manage multiple projects and adjust to changing priorities.
• High proficiency in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently with minimal supervision and collaboratively within a diverse, team‑oriented environment.
• Strong attention to detail and commitment to accurate documentation in accordance with SOPs and regulatory expectations.
• Demonstrated integrity, discretion, judgment, and personal responsibility in a regulated environment.

Additional Skills & Qualifications

• Technical writing and SOP writing experience preferred.
• Prior experience in bioreactor or suspension cell culture operations is a significant plus.
• Experience in downstream processing such as tangential flow filtration (TFF), clarification, or large‑scale cell culture strongly preferred.
• Familiarity with Quality Management Systems in a clinical or GMP manufacturing setting.
• Experience working with cellular and gene therapy products and related regulatory requirements.
• Proven ability to support continuous improvement initiatives using metrics and statistical analysis.
• Strong interpersonal skills to train, mentor, and supervise junior staff effectively.
• Ability to maintain a positive attitude and contribute to a collaborative, inclusive team culture.

Work Environment

The work environment is highly team‑oriented and collaborative, with a diverse group of professionals working together in a growing GMP clinical manufacturing facility. The current team is small and expanding, and all work and testing activities are performed in close coordination with colleagues, as tasks are not conducted in isolation. The facility operates state‑of‑the‑art technologies to support cell and gene therapy manufacturing and bioprocessing activities. The typical work schedule is a four‑day format, generally between 7:008:00 a.m. and 5:306:30 p.m., and requires flexibility, as some days may extend later with adjusted start times on subsequent days to balance hours when possible. The dress code is business casual with appropriate lab attire required in production and laboratory areas, including adherence to safety and GMP gowning practices. The culture emphasizes teamwork, clear communication, continuous growth, and a strong commitment to quality and compliance.

Job Type & Location

This is a Contract position based out of Columbus, OH.

Pay And Benefits

The pay range for this position is $28.00 - $28.00/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)

Application Deadline

This position is anticipated to close on Nov 7, 2026.

Workplace Type

This is a fully onsite position in Columbus,OH.

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.