Description
GMP Manufacturing Associate - Cell Culture and Downstream Processing
POSITION SUMMARY:
We are seeking a highly skilled and experienced GMP Manufacturing Associate specializing in cell culture and downstream processing to join our dynamic team. The ideal candidate should have 2-5 years of relevant experience in a GMP (Good Manufacturing Practice) environment, with a strong background in cell culture techniques. As a key member of our manufacturing team, you will play a crucial role in the production of high-quality biopharmaceutical products.
RESPONSIBILITIES:
- Execute and monitor GMP manufacturing processes for cell culture-based production, ensuring compliance with established protocols and regulatory guidelines.
- Perform routine tasks such as media preparation, cell inoculation, bioreactor operation, and harvest operations with precision and attention to detail.
- Collaborate with cross-functional teams, including Quality Control and Quality Assurance, to ensure product quality and compliance with regulatory standards.
- Troubleshoot and resolve process deviations, identifying root causes and implementing corrective actions to maintain manufacturing efficiency.
- Document all manufacturing activities in accordance with GMP standards, maintaining accurate and complete batch records and documentation.
- Participate in technology transfer activities, providing expertise in cell culture processes and contributing to process improvement initiatives.
- Contribute to the training of junior team members and assist in the development of standard operating procedures (SOPs) related to cell culture manufacturing.
- Maintain equipment and work areas in a clean and organized manner, following safety protocols and guidelines.
JOB LEVEL: Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
EXPERIENCE: Typically requires a university degree and a minimum of 2 years of related experience.
COMPLEXITY: Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
SUPERVISION: Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
LOCATION: Oklahoma City, OK. Because it is expected that this individual will work and operate onsite, he or she will be required to relocate to the Oklahoma City headquarters to lead this expanding team.
CANDIDATE QUALIFICATIONS:
- Bachelor's degree in a relevant scientific discipline (Biotechnology, Biochemistry, Biology, or related field).
- 2-5 years of hands-on experience in GMP manufacturing, with a focus on cell culture processes.
- Strong knowledge of bioreactor operations, aseptic techniques, and upstream processing.
- Familiarity with regulatory requirements for the production of biopharmaceuticals, including FDA and EMA guidelines.
- Excellent problem-solving and analytical skills, with the ability to troubleshoot and optimize manufacturing processes.
- Effective communication and teamwork skills, with the ability to collaborate across departments and contribute to a positive team culture.
- Detail-oriented and capable of maintaining accurate documentation in compliance with GMP standards.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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