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Quality Control Associate I

Longeveron
locationMiami, FL, USA
PublishedPublished: 6/14/2022
Manufacturing
Full Time

Job Description

Job DescriptionAbout 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 a motivated and detail-oriented QC Associate I to support our cGMP Quality Control operations. Reporting to the QC Supervisor this role is responsible for assisting in performing routine analytical assays while ensuring compliance with cGMP standards and internal SOPs as well as supporting day-to-day QC activities. The ideal candidate will have a strong scientific foundation and a willingness to learn and grow within a regulated laboratory environment.

**This role is not available for sponsorship, including I-983 participation.

What You’ll Do

  • Participate in laboratory housekeeping, equipment maintenance, and continuous improvement initiatives.
  • Support laboratory operations by keeping track of consumables, reagents, and materials; assist in restocking and coordinating with senior staff to maintain readiness
  • 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+)
  • Assist in draft, review, and revise technical SOPs with guidance
  • Assist in performing and documenting analytical and functional assays to support 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 with senior staff and 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 you'll need

  • Bachelor’s degree in Life Sciences discipline is required
  • 0-1 years of laboratory or internship experience in Quality control, academic research, or related setting
  • Familiarity with at least one of the following techniques preferred: Flow Cytometry, ELISA/MSD, Mammalian Cell Culture, PCR, or Biochemical assays.
  • Basic 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
  • Demonstrates eagerness to learn, adaptability, and ability to work in a team-based environment
  • 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.


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