Senior Scientist (Finish Fill)

Senior Scientist (Finish Fill)

INTERESTED CANDIDATES MAY SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM

OR TEXT JENNA TO SETUP A PHONE INTERVIEW: 419. 980. 5823

Job Description

The GMP Operations Senior Scientist is responsible for guiding all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). Working closely with the Manager and Supervisor of GMP Operations, the Senior Scientist provides hands-on support and leadership for all day-to-day GMP production operations. This includes project timeline management and personnel oversight. The role involves aiding in production efforts to deliver all products in a timely, compliant, and fiscally responsible manner, providing leadership to staff, and conducting hands-on training to ensure operations consistently follow appropriate practices, batch records, and Standard Operating Procedures (SOPs) for manufacturing.

Responsibilities

• Solve, correct, and prevent problems and perform tasks as assigned by leadership, as well as assign tasks to junior staff.
• Work to specific measurable objectives requiring operational planning skills with minimal direct supervision.
• Lead and support a diverse and collaborative team environment, utilizing clear and concise communication to deliver high productivity and contribute to the success of the team and goals.
• Provide leadership in daily operational activities related to the GMP manufacturing of biological products, including leading and executing production processes.
• Ensure the availability of materials and proper documentation surrounding GMP activities and product quality.
• Set and maintain a professional standard within the GMP area.
• Work with GMP Management to enact the strategic direction of the GMP area.
• Support GMP resources and the supply chain, including ordering and maintaining materials inventory to meet production goals.
• Maintain a high standard of accurate documentation on all GMP operations.
• Train and supervise junior staff to ensure the proper operation of facility equipment and adherence to accurate documentation surrounding GMP activities and product quality.
• Guide the Operations Staff in deviation investigations, OOS results, and process troubleshooting while working with GMP Management and Quality Assurance.
• Collaborate with GMP Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
• Work closely with GMP Management to ensure new projects and technologies are incorporated into the GMP area.
• Respond to and take action from alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units.
• Exercise discretion, judgment, and personal responsibility.
• Demonstrate a high level of integrity and maintain a positive attitude.
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
• Pay attention to detail in all job functions.
• Operate in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Document all activities performed according to SOPs.

Essential Skills

• Relevant four-year Life Science degree OR Master's degree.
• Five years of relevant experience (with a four-year degree) OR two years (with a Master's degree).
• Background in the life sciences, biotechnology, or gene therapy industries preferred.
• Prior experience in a GMP or GLP setting strongly preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Highly skilled in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting.
• Technical writing/SOP writing experience preferred.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Knowledge of GMP or bioprocessing.

Additional Skills & Qualifications

• Prior experience in Suspension or Bioreactors is a big plus.
• Prior downstream, TFF, clarification, or large-scale cell culture experience strongly preferred.

Pay and Benefits

The pay range for this position is $31.00 - $36.00/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 Columbus,OH.

Application Deadline

This position is anticipated to close on Apr 1, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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.

Salary : $31 - $36