Quality Control Associate III
Quality Control Associate III
Posted on :
02-10-2025
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1 Vacancy
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Job Description
About Us
Longeveron Inc a publicly traded (NASDAQ: LGVN) clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions with our headquarters located in Miami FL.
Our lead investigational product is laromestrocel which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair organ maintenance and immune system function we can develop safe and effective therapies for some of the most difficult rare diseases and conditions associated with aging.
About the Job
We are seeking an experienced and knowledgeable QC Associate III to support our cGMP Quality Control operations.
Reporting to the QC Supervisor this role is responsible for independently performing advanced analytical assays while ensuring compliance with cGMP standards and internal SOPs. The ideal candidate will have extensive experience with bioanalytical methods and a strong understanding of cGMP regulations in a laboratory setting.
**This role is not available for sponsorship including I-983 participation.
What Youll Do
What youll need
What we offer
At Longeveron employee compensation also includes bonus and equity compensation in addition to several generous benefit programs including:
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website employees or Human Resources. Longeveron Inc will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Longeveron is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Longeveron we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race color sex religion marital status sexual orientation national origin disability veteran status genetic information pregnancy or any other protected characteristic as outlined by federal state or local laws.
Longeveron Inc a publicly traded (NASDAQ: LGVN) clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions with our headquarters located in Miami FL.
Our lead investigational product is laromestrocel which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair organ maintenance and immune system function we can develop safe and effective therapies for some of the most difficult rare diseases and conditions associated with aging.
About the Job
We are seeking an experienced and knowledgeable QC Associate III to support our cGMP Quality Control operations.
Reporting to the QC Supervisor this role is responsible for independently performing advanced analytical assays while ensuring compliance with cGMP standards and internal SOPs. The ideal candidate will have extensive experience with bioanalytical methods and a strong understanding of cGMP regulations in a laboratory setting.
**This role is not available for sponsorship including I-983 participation.
What Youll Do
- Prepare experimental materials using Standard Operating Procedures Good Laboratory Practice and safety guidelines
- Maintain accurate complete and compliant records of all procedures experiments and data in accordance with data integrity principles (ALCOA)
- Draft review and revise technical SOPs; apply working knowledge of design control and quality systems to support documentation needs
- Perform and document analytical and functional assays supporting multiple clinical research protocols and GMP manufacturing lots ensuring timely and reliable results
- Assist in the design execution analysis and interpretation of experiments including method development troubleshooting and validation activities
- Prepare experimental and test materials following Standard Operating Procedures (SOPs) Good Laboratory Practices (GLP) and established safety guidelines
- Support assay qualification validation and tech transfer efforts as required
- Collaborate cross-functionally with Manufacturing Quality Assurance and Process Development teams to ensure QC testing aligns with product release timelines and regulatory expectations
- Follow aseptic techniques and biosafety protocols appropriate for handling cell therapy materials and ensure a contamination-free testing environment
- Participate in continuous improvement initiatives to enhance QC laboratory operations and assay performance
What youll need
- Bachelors degree in Life Sciences discipline is required
- Minimum of 4 years experience with at least 2 years in a Quality Control role and application of GMP principles in cell therapy manufacturing is required
- Working knowledge and method validation experience in Flow Cytometry ELISA/MSD Mammalian Cell Culture PCR and Biochemical assays
- Working knowledge of current Good Manufacturing Practices (GMPs) 21CFR 210/211/600s/1271 USP and ICH guidelines
- Strong interpersonal written and verbal communication skills; thrives in fast-paced collaborative environments
- Skilled in problem-solving root cause analysis and making sound decisions with limited or complex data
- Demonstrates sound judgment in selecting appropriate methods and approaches to achieve results
- Able to work flexible working hours including evenings and weekends as needed (included in base salary)
- Able to travel to support external manufacturing and testing activities
What we offer
At Longeveron employee compensation also includes bonus and equity compensation in addition to several generous benefit programs including:
- Medical dental and vision benefits (employee premiums covered at100% & 90% coverage for spouse/family)
- 401(k) plan with company match
- Generous paid time off plan and company holidays
- 2 paid company shutdowns (winter and summer)
- Employee assistance program
- Life and supplemental AD&D insurance
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website employees or Human Resources. Longeveron Inc will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Longeveron is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Longeveron we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race color sex religion marital status sexual orientation national origin disability veteran status genetic information pregnancy or any other protected characteristic as outlined by federal state or local laws.
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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