Senior Bioanalytical Project Manager

il y a 1 semaine

Lyon, France KCAS Bio Temps plein

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field - that’s what Scientists at KCAS Bio get to do every day. If that gets you excited too, then maybe working as a Scientist III at KCAS Bio is a role to consider.

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

**In this role, we will rely on you to**:

- Lead multiple projects in LBA complying to 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
- You define the design of these studies according to the applicable standards and coordinate 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 and mentoring to more junior scientists (Scientists I and II)

**To qualify specifically for this role, you will have**:

- PhD or master’s degree in Immunology, Biochemistry, or related life-science field
- Extensive 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 highly sensitive platforms, ELISpot
- Ability to achieve and maintain high 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
- Good communication skills
- Self-motivated, with the ability to work proactively using own initiative
- Hands-on approach, with a ‘can-do’ attitude
- 5-8+ years’ experience in PK, immunogenicity field
- Good written & spoken communication skills in English
- An experience using a LIMS (Watson type) will be a plus

We are a fast-growing contract research organization (CRO) based in Lyon, pioneering the latest drug development in human health field. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.

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