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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading complex technical change projects within the pharmaceutical industry, focusing on drug product technology transfers and regulatory compliance. Proficient in project management, cross-functional team leadership, and process validation.
Highest-signal resume keywords
Drug Product Technology TransfersProject ManagementCross-Functional Team LeadershipCGMP KnowledgeRegulatory Submission Documentation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical Industry ExperienceTechnical SupportValidationProcess DevelopmentAnalytical Method ValidationSix Sigma DMAICProcess CapabilityRisk Management PrinciplesChange ControlManufacturing Documentation Review
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsLeadership SkillsCollaboration Skills
Tools & Technologies
MS ProjectProject Management Software
Industry Keywords
CGMPFDAEMASmall-Molecule Drug ProductsEHS RequirementsNiche Manufacturing Technologies
About the role
Key responsibilities & impact- Provide technical and project leadership for drug product technology transfers, material source changes and other complex technical change projects
- Lead the full project management cycle, including project charters, implementation plans, resource and budget forecasting, schedules, governance, meetings, action tracking, reporting and stakeholder communications
- Build and lead cross-functional teams involving CMOs, manufacturing sites, Drug Product SMEs, CMC, Quality, EHS, External Supply and other network experts
- Support complex CMO investigations involving manufacturing, analytical or product-quality issues; identify root causes and review corrective and preventive actions
- Lead evaluation, execution and implementation of drug product process and technical changes at CMOs, including change controls
- Serve as technical point of contact for Virtual Site Operating Teams, CMOs and internal stakeholders
- Review and, where necessary, approve drug product manufacturing documentation, batch records, specifications, analytical and manufacturing data, validation documentation and technical records
- Author and review technical reports, protocols, risk assessments, change documentation and regulatory submission content
- Plan and support process validation, analytical method transfer or validation, scale-up and qualification activities
- Lead continuous-improvement and cost-saving initiatives to improve process capability, yield, quality, supply performance and cost competitiveness
- Perform technical assessments and due diligence for new business and source-change proposals
- Identify project and technical risks, issues and dependencies; develop mitigation plans and escalate significant concerns
- Present project status, technical findings, risks, mitigations and recommendations to senior leadership, external stakeholders and governance forums
- Manage assigned project budgets and ensure financial, governance and tax requirements are met
Requirements
What you’ll need- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or a related science
- 7+ years of pharmaceutical industry experience in drug product manufacturing, technical support, validation or product / process development
- Wide knowledge and experience of small-molecule non-sterile drug product technologies, manufacturing and primary packaging processes, equipment and control procedures
- Extensive experience leading complex technical product lifecycle change projects, such as Technology Transfers and material source changes, in the External Supply space
- Ability to lead cross-functional matrix teams, build relationships with CMOs and internal stakeholders, and deliver project milestones
- Ability to work independently, manage concurrent complex projects across sites and functions, and prioritise competing activities
- Strong analytical and problem-solving skills, including Six Sigma DMAIC and Process Capability
- Excellent verbal, written and interpersonal communication skills
- Well-developed leadership, facilitation, teamwork, relationship-building, collaboration, influencing, negotiation and conflict-management skills
- Knowledge and experience of cGMP and Pfizer quality systems
- Knowledge and experience of pharmaceutical drug product regulatory requirements
- Direct experience supporting CMC preparation of regulatory submission documentation for post-approval changes to authorities such as the FDA and EMA
- Legal eligibility to work in Ireland
- Desired: experience working in cross-functional and culturally diverse global teams
- Desired: proficiency with project management and scheduling software, including MS Project
- Desired: basic knowledge of API manufacturing and control processes
- Desired: knowledge of drug product process risk management principles and procedures, such as FMEA
- Desired: knowledge of process safety and general EHS requirements
- Desired: knowledge of niche small-molecule drug product manufacturing technologies, such as soft gel capsules, freeze-dried tablets and hot-melt extrusion
Benefits
Comp & perks- Occasional travel to internal meetings or contract manufacturers
- No relocation support available for this position
- Equal employment opportunity and disability inclusion support
- Reasonable adjustments available for accessibility needs during application and interviewing