Scientist

3 months ago

Guelph, Canada Ceva Animal Health Full time

Ceva is seeking a Scientist who will contribute to the research and innovation process

Ceva Animal Health Canada established itself in Canada with the acquisitions of CentaurVA Animal Health and Vetech Laboratories in October 2011. Our Canadian presence expanded during 2019 when we acquired IDT Biologika subsidiary Gallant Custom Laboratories manufacturer of autogenous vaccines.

Ceva offers an expanding range of products for companion animals, poultry, swine, and ruminants for Canadian customers.

**About the Role**

In this role you will ensure laboratory and clinical activities are performed, in compliance with current scientific knowledge, quality and regulatory requirements, acting as:

- a team member in a project - the interface to Reg Affairs for his/her respective part(s) of the dossier
- the support of all the other departments (marketing, sourcing, GID, QC, QA, Industry...) as the main interlocutor esp. about technical processes and organization.

**Responsibilities**
- Contribute to the research and innovation process.
- Continuously build and ensure access to an external network of experts/scientists and keep a scientific watch to stay aware of new trends/classes of vaccines, antigens and adjuvant/new practices/ technologies in the assigned scientific domains.
- Proactively and opportunistically search for solutions for identified unmet needs.
- Build and coordinate the opportunity team to ensure a rapid and in-depth evaluation of internal and external ideas and opportunities.
- (Co-)write White Papers, ensure regular updates, organize advisory boards.
- Contribute to the Concept Note in order to assess a proposal for a pre-project;;build a task force with transverse experts if needed.
- Propose innovative approach and new scenario when possible.
- Assume Sponsor Representative, Study Director (SD) and Principal Investigator (PI) responsibilities.

Laboratory Management
- Organize technicians activity by setting the 3-6 month priorities.
- Contribute to maintenance of lab activities.
- Benchmark current practices vs. competitors & trends to keep up-to-date knowledge.
- Organize and plan daily/weekly activity.

Pre-clinical and Clinical development
- Plan & execute and deliver clinical studies following defined protocol, in agreed project timing.
- Organize study material and Investigational Veterinary Product shipment, perform clinical work, monitor study (external or internal: site opening, monitoring and closing), follow inclusion rate, propose alternatives to maintain the inclusion rate.
- Write/contribute to the study protocol and to the study report (clinical research file, deviation). Prepare data for statistical analysis.

CRO/CDMO management
- Participate in CRO and CDMO selection. Monitor their activities.

Analytical Development and Analytical services
- Elaborate & develop new assay methods, selecting adequate raw materials, leading the optimization and testing the suitability of the assay.
- Provide scientific and technical contribution for studies and tests performed in the lab.
- Propose experimental plan, innovative approach and new scenario when possible.
- Validate and interpret results obtained by associate scientists.
- Plan and organize stability studies according to guidance, zone and pharmaceutical/biological forms.
- Plan and organize immune reagent preparation and qualification.
- Is involved in the formula choice.
- Elaborate new antigen production methods.

Analytical (& technology) validation and transfer
- Set up validation & transfer methodology according to guidance.
- Write development and/or validation reports according to regulations (PhEur, VICH, GLP).
- Is responsible for QC support and method transfer including control preparation.
- Review data and packages for regulatory submissions and participate in regulatory agency interactions.

Project Management
- Act as a project team member, bringing his/her expertise and support for the success of the missions assigned to him/her (cf. definition of project team member in the PM family).
- Make recommendations in the pre-project.

Compliance
- Maintain GxP compliance for his/her activities.
- Write and comply with SOPs.
- Participate in internal and external GxP audits and inspections.
- Ensure Q.C of the data, take over Principal Investigator (PI), Investigator or monitor responsibilities.
- Contribute to the relationship with external partners, particularly investigators and KOLs.

**About You**
- **You have a Minimum BA/BS in Microbiology or Biology or related field, with 5+ years of relevant experience, or have a graduate degree, (MS or PhD) in a relevant field.**:

- You have working knowledge of microbiology techniques (aseptic technique, preparation of media, culturing organisms, etc.)
- You have experience performing laboratory assays
- You have the ability to participate in clinical trials
- You have the ability to perform and interpret basic statistics
- You have the ability to design and propose experi

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