Method Development Scientist - Harrogate, North Yorkshire, UK

Recruiter
Covance
Location
Spacey Houses
Posted
12 Jan 2018
Closes
11 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

Covance, a leading global drug development services company, is looking for Method Development Scientist to join our Immunochemistry team based in Harrogate, North Yorkshire.

Responsibilities:

- Ensures that the study is performed in accordance with the study Protocol and the Covance Standard Operating Procedures.
- Ensure that the study is performed to the required scientific and regulatory standards.
- In-depth and up to date knowledge of UK/OECD GLP and GCP regulations as applicable, RA roles and responsibilities.
- To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems.
- Ensure that all study communication is maintained and carried out to meet Sponsor requirements.
- Demonstrates knowledge of Sponsor requirements and plans accordingly (timelines, critical deadlines etc).
- Provides Sponsor feedback to team.
- Produces study Protocols, APs and Reports to meet Sponsor and regulatory requirements.
- Proactively manages Sponsor and study changes to meet timelines and ensure all additional costs are captured (work scopes).
- To ensure that all studies are archived according to current SOP.
- In-depth knowledge of relevant assays, able to advise internal/external Sponsors on standard study designs.
- Make decisions on study results/data and follow through with Sponsor.
- Problem solves adverse events within studies and performs troubleshooting.
- Providing advice and training to shadow RA's during conduct of studies.
- Fully conversant in interactions with support areas across the company.
- Responsible for on time delivery targets (Protocols, results, Reports).
- Demonstrated ability in organising and hosting Sponsors visits (internal and external).
- Understands financial process and financial/resource issues. Contributes to and ensures all studies are costed and quoted.
- Effective use of CMS for scheduling and all resources (people, equipment and materials).
- Evaluates existing departmental procedures and systems and participates in process improvements.
- Develops teamwork with study team, Business Development and other departments.
- Supports and encourages the development of team members.
- Constructive participation in departmental meetings, MD, scheduling etc.
- Performs other related duties as assigned.

Education / Qualifications

- The post holder should ideally have a relevant scientific degree and an appropriate amount of relevant laboratory experience.

Experience

- Experience in ELISA/Ligand Binding Assay (LBA) work
- Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel and PowerPoint).
- In-depth understanding of Health and Safety policies, Company Policies and Procedures and an in-depth understanding of GLP and GCP.
- The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external Sponsors, suppliers, etc.
- The post holder should have experience of performing the Responsible Analyst role for most study types and be fully competent at a 110 grade.