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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in API manufacturing processes, technology transfer, and project management within the pharmaceutical industry. Proven ability to lead cross-functional teams, manage supplier qualifications, and ensure compliance with regulatory standards.
Highest-signal resume keywords
API Manufacturing ExpertiseTechnology Transfer LeadershipProject Management ProficiencyRegulatory Compliance KnowledgeOperational Excellence Tools
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
API DevelopmentProcess ValidationQuality Management SystemsGMP KnowledgeRisk Management PrinciplesAnalytical Method TransferProcess SafetyDocumentation RequirementsSynthesis and PurificationCost Improvement Projects
Soft Skills
Problem SolvingCommunication SkillsRelationship BuildingOrganizational SkillsIndependent Work
Tools & Technologies
Project Management SoftwareExcelPGS Databases
Industry Keywords
Pharmaceutical IndustryContract ManufacturingDrug Product ProcessesEHS RequirementsTechnology TransferSmall MoleculesQuality InvestigationsAPI Supplier QualificationMultifunctional TeamsRegulatory Environment
About the role
Key responsibilities & impact- Transfer APIs successfully to Contract Manufacturing Organisations, generating comparable physical and chemical quality for Drug Product and qualifying relevant markets
- Coordinate action plans to meet project timelines and milestones
- Identify, communicate, and implement resolutions to project and plan issues
- Lead Technology Transfer Teams and sub-teams involving API sites, CMOs, Drug Product sites, SMEs, CMC, QA, EHS, and External Supply
- Lead ES API source change activities and qualification of alternate CMO suppliers
- Build and lead cross-functional project teams and maintain project/program implementation plans
- Chair meetings, schedule activities, track actions, and prepare reports, minutes, presentations, and communications
- Investigate API transfer and scale-up problems and recommend solutions
- Present technical findings and recommendations to senior leadership and external stakeholders
- Analyse API processes and quality documents and compare CMO proposals
- Write and review process-related documents, technical reports, protocols, and regulatory submissions
- Lead complex quality investigations involving chemistry, processing, analytical problems, supply, compliance, or financial challenges
- Engage Drug Product SMEs and the Material Characterisation Team to ensure API physical-property requirements are met
- Serve as primary technical leader for API manufacturing processes, including synthesis and purification
- Coordinate technical data collection and review CMO documentation, operating instructions, batch records, analytical and manufacturing data, specifications, and reports
- Manage process validation activities and project management requirements
- Manage Cost Improvement Projects to reduce third-party API costs
- Provide SME input to improve API network performance, including Ppk and yield
- Support CMO issue resolution involving manufacturing, risk mitigation, product quality, analytical method transfer, or validation data
Requirements
What you’ll need- Bachelor’s degree in chemistry, chemical engineering or related scientific discipline
- Advanced degree preferred
- Broad post-Bachelor's experience relevant to the pharmaceutical industry
- Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations
- Experience organising, planning, and problem solving related to qualifying new API suppliers
- Ability to build constructive working relationships with multifunctional teams and CMOs
- Knowledge of documentation requirements for filing processes, quality systems, and production
- SME knowledge in API development, process or source change qualification, and API manufacturing
- Broad knowledge of technology transfer and API manufacturing
- Ability to work on multiple projects with multiple sites and functions
- Ability to work independently and provide innovative solutions
- Ability to manage and prioritise competing priorities and communicate verbally and in writing to various audiences
- Familiarity with the pharmaceutical regulatory environment and regulatory change processes
- Demonstrated use of Operational Excellence tools and DMAIC approach to investigations
- Minimum five years of work experience in a contract manufacturing-related role involving small molecules
- Minimum five years of direct experience leading commercial API technology transfers and alternative source qualifications at external CMOs for products registered in multiple global markets
- Knowledge of production Quality, GMP, and validation processes, procedures, and policies
- Proficiency with project management software, Excel and PGS databases
- Knowledge of Risk Management principles
- Knowledge/experience of Drug Product processes, Process Safety and general EHS requirements
- Legally eligible to work in Ireland
Benefits
Comp & perks- Hybrid work arrangement
- No relocation support available
- Equal employment opportunities
- Reasonable adjustments and disability inclusion support