Scientist II - LBA and Biomarkers

Posted 7 Days Ago
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Lyon, Rhône, Auvergne-Rhône-Alpes
3-5 Years Experience
Biotech
The Role
Lead multiple projects in LBA, comply with regulatory guidelines, set up and supervise PK/ADA studies, write project documentation, promote scientific results, implement new lab techniques, provide technical training, and maintain high standards.
Summary Generated by Built In

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what Scientists at KCAS Bio get to do every day. 

If that gets you excited too, then maybe working as a Scientist II at KCAS Bio is a role to consider. 


When you work as a Scientist II at KCAS Bio, you get to further our mission as the core of KCAS Bio by carrying out and contributing to all aspects of our studies to ensure the success of our clients. 

 

As a Scientist II at KCAS Bio, you will qualify, validate, and execute test methods for the evaluation of soluble and cellular biomarkers, for pharmacokinetics PK/toxicokinetic TK and immunogenicity in a service provider company specialized in non-regulated and regulated bioanalysis.


Learn more about what we do: KCASbio.com

In this role, we will rely on you to:

  • Lead multiple projects in LBA complying with applicable ICH M10/FDA/EMA guidelines under both Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) environments
  • You set up and supervise PK/ ADA, biomarkers qualification/validation and testing studies within the laboratory 
  • With supervision by senior scientists, you define the design of these studies according to the applicable standards andcoordinate a technical team for the good execution of experiments for client sponsored projects 
  • You ensure customer contact in connection with the studies you manage, you provide an advisory role
  • Write project documentation (analytical test methods, development reports and protocols) of high complexity 
  • Participate in the scientific promotion of results 
  • Be proactive in implementing new techniques and technologies in the lab to offer innovative services to our clients 
  • Supervise/provide technical training of students or collaborators

To qualify specifically for this role, you will have:

  • PhD ormaster’s degreein Immunology, Biochemistry, or related life-science field 
  • Experience with regulatory policy compliance (GLP/GcLP) 
  • Demonstrated proficiency with PK and/or ADA validation 
  • Demonstrated proficiency with biological techniques for biotherapeutic characterization, including immuno-assays on multiple platforms or formats, such as conventional or bridging ELISA, multiplex, or sensitive platforms, ELISpot
  • Ability to achieve and maintainhigh standards with meticulous attention to detail 
  • Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales
  • Strong analytical and problem-solving ability
  • Self-starter who can ‘hit the ground running’ 
  • Good team player
  • Effective communication skills 
  • Self-motivated, with the ability to work proactively using own initiative
  • Hands-on approach, with a ‘can-do’ attitude
  • 3+ years’ experience in PK, immunogenicity field and/ or biomarkers 
  • Good written & spoken communication skills in English
  • An experience using a LIMS (Watson type) will be a plus 

What we offer you  

In addition to the usual benefits, we offer you the opportunity to develop your professional career through a strong training policy. You will evolve within a team with a human face, concerned about the well-being and inclusion of all its employees.

Who we are  

Based in Lyon, KCAS Bio is a fast-growing laboratory recognized for its expertise in the development of innovative treatments in human and animal health. We are looking for new employees who want to bring their enthusiasm and their quest for collective success to strengthen our teams. At KCAS Bio, we advance both great science AND great people. 

Top Skills

Master’S Degree
Phd
The Company
HQ: Olathe, Kansas
236 Employees
On-site Workplace
Year Founded: 1979

What We Do

With its presence in three locations across North America and Europe, KCAS Bio is a leading contract research organization (CRO) employing top scientific talent and providing comprehensive bioanalytical services to the global biopharmaceutical industry from early discovery support through product registration and beyond.

The collaboration of the three entities allows for global support in bioanalytical, biomarker, immunogenicity, cellular and molecular assay services along with clinical kitting and sample management. The KCAS family of companies operates in state-of-the-art facilities in the United States and Europe.

This business structure enables the expertise, capacity, and flexibility to support the development of all types of drugs, biologics, cell and gene therapies to improve health worldwide.

Our purpose is to help accelerate the discovery and development of life-changing drugs smoothly, safely and sustainably.

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