Careers


Position:  Senior Scientist

Date:  June 1, 2018

Job Summary:  Longeveron LLC is an emerging cellular therapy whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of novel stem cell products.  We are seeking a dynamic and experienced professional to grow with our team.

Major Areas of Responsibility and Professional Requirements:

  • Prepare experimental materials using Standard Operating Procedures, Good Laboratory Practice and safety guidelines.
  • Maintain accurate records of procedures and experiments.
  • Experience drafting technical SOPs, working knowledge of design control
  • Perform experiments and analyses for multiple clinical research protocols
  • Assist with analysis of experiments as assigned.
  • Serve as contact point as required.
  • Adhere to work hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary);
  • Strong attention to detail.
  • Perform other related duties as assigned or requested.

Technical Requirements:

  • Flow Cytometry (familiarity with Diva and FloJo desirable).
  • ELISA.
  • Mammalian cell culture (2-yrs minimum).
  • PCR.
  • Biochemical assays.

General Requirements:

  • Excellent interpersonal/human relations skills; ability to work collaboratively in a fast-paced team environment.
  • Excellent written and verbal communication skills.
  • Strong attention to detail.
  • GLP/GDP experience.

Minimum Education/Experience:

  • Ph.D. or Masters of Science in Biology, Biochemistry, or related field with commensurate experience.
  • Minimum of 5 years bench experience.
  • Industry experience, preferred.

Position:   Clinical Project Manager

Date:  June 5, 2018

Longeveron LLC is an emerging life sciences company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials involving novel stem cell products. We are seeking a dynamic and experienced professional to grow with our team as a Project Manager. Now is an exciting time to join Longeveron. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. Our work atmosphere is fast paced, stimulating, team based and results oriented.

Longeveron is currently seeking a Clinical Project Manager with string clinical trial management and oversight experience to join our talented and motivated team.  As part of the clinical trials team, you will demonstrate your operational expertise and strategic leadership to drive operational excellence.

Under general supervision, this position drives planning and decision-making, develops implementation strategies and leads efforts for projects in the U.S. and abroad.  You will work with team members to create and maintain project plans and timelines, which may include budget, definition, scope, project staffing, financial resources allocation, dependencies and target dates. You will further provide support for or have accountability for operational delivery, while optimizing speed, quality and cost of delivery and in accordance with SOPs, policies and practices.

Major Areas of Responsibility

  • Possesses proven experience in managing clinical trials for an industry sponsor across all phases;
  • Plays instrumental role in clinical trial organization and oversight, participates in determining the feasibility of research sites, oversees trial initiation at research sites, liaises with research sites and Clinical Research Organization, and maintains Good Clinical Practice (GCP) standards;
  • Prepares and reviews documentation related to clinical trials;
  • Interacts with consultants, vendors and certain governmental agencies to maintain timely and compliant trial initiation and conduct;
  • Communicates effectively across all functional groups so that schedules and scopes of the projects are clear;
  • Assists in the development of project budgets and tracks project-related costs;
  • Develops project timelines and tracks contract deliverables (in Gantt charts or similar tool);
  • Assembles, analyzes and reports project metrics for internal and external stakeholders;
  • Identifies project issues such as resource, technical or scheduling constraints, and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions;
  • Ensures that projects are completed on time, within budget and scope, and conform to pre-established quality standards;
    Assists with the development of project plans and monitors for accomplishment;
  • Collaborates with internal and external stakeholders while maintaining sensitive, confidential and trade secret information;
  • Works hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary) and position requires frequent domestic and international travel as needed; and
  • Other duties as assigned.

Requirements and Qualifications

  • Must have specific experience initiating and overseeing clinical trials on behalf of pharmaceutical sponsor (preferred) or Contract Research Organization.
  • Bachelor’s Degree or Master’s Degree in scientific discipline preferred.
  • Minimum of 3-5 years of biotechnology or pharmaceutical experience.
  • Minimum of 5-10 years of relevant Project Management experience with a strong understanding of all aspects of clinical trial execution. Management of biological projects is preferred.
  • Demonstrated working knowledge of GCP, FDA and ICH regulations and guidelines required. Previous experience in the conduct of global clinical trials preferred.
  • Extensive regulatory experience is required.
  • Understanding of biotech or drug product development activities and of multi-project planning and coordination is required.
  • Demonstrated leadership, interpersonal, problem solving, and conflict resolution skills.
  • Must be highly organized and possess the proven ability to juggle multiple competing tasks and demands. This position requires collaborating closely and positively with team members, and working independently.
  • Must be a self-starter and have a positive and flexible attitude.
  • Thrives in a start-up environment where it is critical to take initiative, and get things done with limited instruction and oversight.
  • Advanced proficiency in Outlook, Word, Excel, PowerPoint, etc.
  • Able to travel approximately 15% (depending on Longeveron requirements).Longeveron LLC is dedicated to a diverse workforce and Drug Free work environment.
    Qualified candidates are encouraged to apply.

For more information, please contact:

info@longeveron.com


Position:   Medical Writer

Job Summary:  Longeveron LLC is an emerging cellular therapy whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of our novel stem cell products.  We are seeking a dynamic and experienced professional to grow with our team as a                                                                                                                                                                          Medical Writer.  This position is on-site at Longeveron’s headquarters in Miami, Florida.

Responsibilities:

This position involves preparing scientific and regulatory documents on behalf of Longeveron for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator’s Brochures); performing literature searches; preparing and editing manuscripts, meeting reports and proceedings, and safety documents; and data analysis.  This position also requires experience in writing grants proposals.  Additional responsibilities include:

  • Develop necessary regulatory expertise, and propose regulatory strategies, meetings and response to FDA comments.
  • Prepare medical/scientific/regulatory documents, SOPs, and miscellaneous documents.
  • Maintain databases.
  • Contribute to design of databases of scientific and drug development information.
  • Prepare grant applications to federal and state agencies, foundations, etc.
  • Adhere strictly to stipulated timelines.
  • Adhere to work hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary);
  • Perform other related duties as assigned or requested.

Minimum Education & Experience:

  • D. in pharmacology, biochemistry, molecular biology, immunology, or a related field; or PharmD (required).
  • Familiarity with Geriatrics, cardiovascular, immunology a plus.
  • Industry experience (preferred).
  • Minimum of 5 years of experience in medical writing in a CRO or pharmaceutical/biotech industry (strongly desired).
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
  • Experience in managing and directing medical writing projects.
  • Strong familiarity with Regulatory Agency guidelines, including Good Clinical Practice.
  • Advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
  • Expertise in analyzing and describing research results.
  • Familiarity with statistical principles/concepts used in clinical research.
  • Superior computer skills and general computer literacy.
  • Excellent communication skills (English language; written and verbal)
  • Proficiency in Microsoft Office (particularly Word, Excel and PowerPoint)
  • Excellent interpersonal/human relations skills; ability to work collaboratively in a fast-paced team environment.
  • Logical thinking, attention to detail.

Submission of published writing samples will be requested during the interview process. A writing test may also be required.

For further detail please contact: 

info@longeveron.com