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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical method development, validation, and transfer within the biopharmaceutical industry, focusing on late-phase product lifecycles and regulatory submissions. Strong leadership and stakeholder management skills are essential for driving analytical product strategies and supporting cross-functional teams.
Highest-signal resume keywords
Analytical Method DevelopmentRegulatory Submissions (IND, IMPD, BLA, MAA)Comparability StudiesDrug Substance and Drug Product ManufacturingStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical Method ValidationAnalytical Product StrategiesSpecification SettingStability Study EvaluationsCritical Quality Attribute (CQA) AssessmentTechnical Risk Assessment (TRA)Product Performance Qualification (PPQ)Continuous Process Verification (CPV)Root-Cause AnalysisNovel Analytical Technologies
Soft Skills
LeadershipStakeholder ManagementResilienceContinuous ImprovementPerformance Driving
Tools & Technologies
Process Analytical Technology (PAT)
Industry Keywords
Biopharmaceutical IndustryLate-Stage ProductsTechnical TransfersRegulatory DocumentsHealth-Authority Inspections
About the role
Key responsibilities & impact- Lead and deliver business-critical projects supporting analytical aspects of late-phase product lifecycles
- Provide technical analytical leadership for programs, projects, NPI, product transfers, change management, and regulatory submissions
- Own and maintain Analytical Product Strategies through the post-approval product lifecycle
- Recommend specification and stability strategies and novel analytical technologies based on product needs
- Manage comparability studies and define characterization strategies for post-approval changes
- Compile and recommend acceptance criteria for release and stability testing
- Provide analytical expertise for comparability protocols, reports, regulatory documents, and submission Q&A
- Partner with R&D, Global Supply Chain, Technical, and Regulatory teams in a matrix organization
- Embed method knowledge in technical transfers to GSK and external sites
- Drive evaluation of new technologies, including PAT, for analytical testing and product control strategies
- Support complex root-cause-analysis investigations with analytical expertise
- Defend Analytical Product Strategies during health-authority inspections
Requirements
What you’ll need- Degree-qualified; relevant education/qualifications such as BS/MS in pharmacy, chemistry, biology, biochemistry, or a related technical discipline
- Experience with analytical method development, validation, and transfer
- Experience in the biopharmaceutical industry, including late-stage products and Critical Quality Attribute (CQA) assessment
- Strong understanding of drug substance and drug product dose-form manufacturing disciplines and their relationship with analytical testing and control strategy
- Experience authoring regulatory files, including IND, IMPD, BLA, and MAA
- Strong relevant knowledge, such as small-molecule science
- Experience supporting new product introduction or complex lifecycle investigations
- Strong leadership, stakeholder-management, people, resilience, continuous-improvement, and performance-driving skills
- Preferred: knowledge of statistics related to CPV, test-method equivalence assessment, specification setting, and stability-study evaluations
- Preferred: knowledge of technical risk assessment (TRA), product performance qualification (PPQ), and continued process verification (CPV)
Benefits
Comp & perks- Agile working culture and flexibility opportunities
- Company-wide benefits (details referenced via GSK’s Life at GSK webpage)
- Equal Opportunity Employer
- Adjustments and support available during the recruitment process