Cell Culture MFG Specialist
Our client is developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.
This Scientist will perform patient product manufacturing, typically as an operator, for a variety of cell therapies in cancer immunotherapy and stem cell regenerative medicine. This role works both independently and collaboratively across the 5 functional teams: Process Development & Manufacturing, Regulatory Affairs, Quality Systems, Operations and Finance & Administration. Opportunities for Process Development will be available to incumbents in this position based on operational needs and current projects. This position entails work under Biosafety Level 2 (BSL2) and current Good Manufacturing Practice (cGMP) level conditions and adherence to corresponding requirements.
Perform complex (lab and/or field) experiments for a major portion of the research project. Maintain detailed records of experiments and outcomes.
Interpret and analyze results, often where few guidelines exist. Based on prior results, contribute to development of new research protocols and procedures or adaptation of existing protocols.
Make recommendations on plan design and/or research direction to principal investigator.
Work with health and safety department to ensure lab complies with regulations and all required trainings.
Participate in multidisciplinary teams across different faculties or schools.
Oversee supply and equipment budget under supervision of principal investigator or business manager.
Perform ongoing literature review to remain current with new procedures and related research; present findings for lab work group.
Contribute substantively to the preparation of papers for publication, especially in the results section. May contribute to publication of findings and present ongoing work and findings to colleagues at academic conferences.
Supervise (either formally or informally) staff or students as needed, including oversight and instruction on techniques, as well as consultation on project work. Serve as technical resource for other research staff.
Perform general lab maintenance as needed; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory equipment.
Bachelor's degree in chemistry, microbiology, or other related field of study
Aseptic technique experience is preferred
cGMP experience is preferred
Knowledge and following SOPs and batch records preferred
Mammalian Cell Culture experience
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related scientific field and two years of related experience, or Master's degree.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Comprehensive understanding of scientific principles.
General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications.
Strong analytical skills and excellent judgment.
Ability to work under deadlines with general guidance is essential.
Excellent organizational skills and demonstrated ability to accurately complete detailed work.
Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds.
Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts.
Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls. ? Must have correctible vision to perform duties of the job.
Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours.
Ability to lift heavy objects weighing up to 50 pounds.
Ability to work in a dusty, dirty, and odorous environment. ? Position may require repetitive motion.
Additional PHYSICAL REQUIREMENTS:
Work in ISO-7 (209E Class 10,000) clean room for multiple hours at a stretch depending on needs and demands of project and product being manufactured
May require working in close proximity to blood borne pathogens.
May require work in an environment where animals are used for teaching and research.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly Services®
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