Scientific Writer

Job Description – Contract Scientific Writer Location Maidenhead

Development, validation and management of assays to support Gene Therapy programs
• Input for selection of the most appropriate methodology, assay development and design
• Technical transfer of assays from academic laboratories into GMP/QC facilities
• Procurement of materials and reagents
• Provide expert knowledge and guidance during the development and validation of Gene Therapy product dosing assays
• Oversee document management and data trending

Assist in the scheduling, management of and data trending for stability programs for Gene Therapy products and critical starting materials

Management of outsourced Analytical activities and CROs
• Negotiation, execution and management of contracts for sample analysis with vendors.
• Scheduling analytical testing with vendors in line with business needs
• Technical input into assay validation and setting specifications
• Responsibility for review and sign-off of protocols reports and data
• Trouble- shooting and investigations into out of specification data
• Recommend vendors and monitor vendor performance and delivery according to content, timelines and budget.
• Negotiate Change of Scope orders to ensure best value.

Contribute to preparation of IND/IMPD/CTA documents and responses to questions
• Provide expert technical content for Meeting Request Letters, Briefing Documents and technical responses

Represent analytical development/transfer/ validation activities at Asset teams and / or lead Asset sub-teams
 

Critical Competencies:
• QC trained scientist with assay validation experience
• Previously worked within a QC validation / testing laboratory for late phase / commercial biologics
• Strong scientific background and ability to troubleshoot a range of biological analytical techniques relating to gene therapy products (eg potency, molecular and ELISA-based vector titration assays, full / empty capsid determination, infectious titre assay, aggregation techniques)
• Experience of analytical method development
• Experience in technology transfer and bridging studies for analytics
• Ability to effectively manage and co-ordinate activities at CROs and CDMOs

Preferred Competencies:
• Previous experience in AAV gene therapy
• Awareness of regulatory requirements and experience writing regulatory analytical documentation

Behavioural and Interpersonal:
• Organised individual with the ability to manage complex projects, deliver to timelines and work in a demanding environment
• Fast learner
• Strong team player
• Excellent written skills
• Clear communicator of data, progress and risks both written and orally