Assay Validation Scientist

Job description

Assay Validation Scientist

The Role:

 

To provide expert leadership and oversight of assay validation to ensure projects (including custom work) are carried out with the appropriate scientific and regulatory standards while ensuring on time delivery and compliance to appropriate quality standards (GLP / cGMP standards)

 

·  Direct and lead assay validation activities within the site.
·  Work with Quality Assurance and Regulatory to monitor compliance of assay validation programme to regulatory guidance and Good Manufacturing Practice.
·  Ensure assay updates are identified, managed, and completed on time
·  Have direct involvement and interaction (with operational staff) during performance of work directly leading to successful completion of validation projects
·  Prepare project timelines for all projects working with team members to ensure all milestones are achieved.
·  Design and prepare protocol and report templates pertaining to assay validation studies.
·  Directly involved in statistical analysis of data generated from validation studies
·  Work with Operations and Quality Assurance to ensure all client products and reports are delivered in a timely and cost-effective manner meeting all quality and client requirements.
·  Direct interaction with clients to provide expertise and guidance on assay validation for internal and customer driven projects.
·  Work closely with Operational teams and Quality Assurance to identify potential areas of improvement as they pertain to assay validation requirements. 
·  Lead assay validation meetings and including cross functional scientists’ sessions.
·  Ensure that scientific staff have full training in assay validations, expectations and site company policies
·  Comply with all applicable Health and Safety rules and regulations.
·  Actively maintain a clean, tidy and safe work environment.

 

Who you are:

 

·  Candidates must have a minimum BSc Honours Degree in Biological/life Science subject. 
·  Candidates must have extensive experience in a regulated scientific environment.
·  Assay Validation experience is essential

 

 

 

Job Requisition ID: 207745

Location: Glasgow

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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