Biopharm Analytical COE Lead
Job Purpose: Serve as the GMS analytical expert on Biopharm project teams from late stage development through routine commercial supply.
Ensure the analytical methods/technologies implemented for commercial supply are robust and remain fit for purpose.
Manage analytical methods/technologies risks identified through commercial supply data trending.
• Interface with R&D project development teams and provide technical and compliance expertise into the analytical method development, risk assessments, validations and transfers.
• Input into project control strategy, including CQA assessments, testing strategy and specifications.
• Contribute to registration content (authoring, review and responses to questions).
• Assess the ongoing performance of the analytical methods for commercial test sites (internal and external).
• Provide technical and compliance expertise for technical issues and mitigation strategies for commercial test sites (internal and external).
• Lead GSK analytical oversight of post approval analytical activities at contract testing sites/CMOs
• Input into post approval project stability programs.
• Drive post approval analytical method improvement initiatives.
• Provide project based technical input into internal and external inspections/audits.
• Lead matrix teams as required.
• Analytical method development, optimization or troubleshooting
• Technical writing experience (reports, protocols, methods, regulatory submissions)
• Experience with statistical analysis and interpretation
• Participation within cross-functional/matrix teams
• Good communication skills, verbal and written
• Bachelors degree in chemistry, biology, biochemistry or a related field
• 5 years' experience within a biopharmaceutical testing environment
• 3 years' experience within a cGMP environment
Experience working with cross-functional teams
Why GSK? Because GSK's BioPharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance - Being accountable for quality and safety.
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