Position: Manufacturing Associate
Longeveron LLC is a leading company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of novel stem cell products.
This position will actively be engaged in cGMP manufacturing operations as well as research and development functions leading to potential improvements in the manufacturing process. The candidate for this position will be expected to take responsibility for the isolation and processing of mesenchymal, bone marrow cells, other somatic cell types as well as any additional cellular therapy products that will be processed in conformance with cGXP regulations (clinical, documentation, laboratory, manufacturing, etc.). In addition to possessing complex skills, the candidate must be able to exercise independent judgment and work without supervision. The prospective hire will ideally have experience with cell culture, density gradient separation, purification, positive/negative selection using antibodies, determination of purity/quality and other skills deemed appropriate including but not limited to excellent aseptic technique. The candidate is also expected to contribute actively to the development and testing of new methodologies and technologies, including the design and execution of experiments, the evaluation of new equipment, reagents, and other materials, and to make recommendations based on expertise. Candidate should also have experience writing, reviewing and revising all documents required for the manufacturing of cellular therapy products.
Major Areas of Responsibility:
- Responsible for all cellular therapy manufacturing processes including but not limited to isolation, culture, cell count, viability, and cryopreservation of cells. Must exercise independent judgment at appropriate times, and troubleshoot as needed.
- Responsible for media preparation, equipment cleaning and maintenance, reagent receipt and inspection, data entry and analysis, stocking of supplies, and the proper handling of day to day functions of the cGMP areas.
- Assist in the development of training programs.
- Ensure compliance with current safety requirements.
- Ensure compliance with all current SOPs.
- Coordinate manufacturing activities with other departments.
- Maintain knowledge of technological advancements.
- Ability to revise existing SOPs and draft new SOPs, as necessary.
- Ability to revise existing batch production records and draft new, as necessary.
- Properly document all processes and procedures while adhering to cGMPs and internal SOPs.
- Other duties as assigned.
- May require working nights, weekends and holidays.
- Bachelor’s degree in biology, cell biology, microbiology or similar field with five years of experience in a cGMP environment.
- Fluent (oral/written) English.
- Good interpersonal and organizational skills.
- Attention to detail and accuracy.
For inquiries please contact:
Longeveron LLC is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Life Science & Technology Park, 1951 NW 7th Avenue, Suite 520, Miami, Florida 33136