Director - Analytical CMC

PE Global is recruiting for a Scientific Director - Contractor, Analytical Strategy & Lifecycle (Analytical CMC) on behalf of our client based in North Dublin. The role focuses on developing, managing, and executing analytical CMC strategies for late-stage assets transitioning to commercialization and lifecycle support of commercial products. This senior, independent contributor role requires deep biologics analytical sciences expertise and strong technical writing to support regulatory submissions and global filings.

The role provides scientific and regulatory leadership across assets, covering analytical methods, specifications, reference standards, and comparability approaches. Key deliverables include high-quality regulatory documents (e.g., justification of Specifications, analytical comparability protocols/reports, scientific briefing packages, responses to health authority questions) and subject matter expertise in analytical control strategies. Candidates should be able to influence in matrixed environments, communicate effectively with stakeholders, and operate at high technical and regulatory standards.

• Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialization.
• Lead the design, authorship, and critical review of regulatory and technical deliverables, including: Justification of Specifications (JOS); Analytical Comparability Protocols and Reports; Scientific Briefing Documents; and Responses to Analytical Health Authority Questions.
• Provide scientific expertise to lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.
• Serve as a subject matter expert in analytical sciences, advising cross-functional matrix teams and ensuring alignment with regulatory expectations.
• Partner with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure strategies are executed with scientific rigor and regulatory success.
• Provide scientific leadership during complex analytical troubleshooting, method updates, validations, and tech transfers.
• Ensure clarity, accuracy, and compliance in all technical deliverables.
• Operate as a senior independent contributor, driving execution of the analytical control strategy with minimal oversight.

• Extensive knowledge and hands-on experience in analytical CMC for biologics, including specification setting, analytical comparability strategy and risk assessments, method lifecycle and change control, and reference standard strategy.
• Proven track record of independently authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses).
• Demonstrated ability to provide strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and manage health authority communications (IRs, FUMs, PMCs).
• Strong technical writing and communication skills, translating complex science into clear regulatory language.
• Ability to lead, influence matrix teams and drive alignment across functions without direct authority.
• Solid understanding of analytical methods used for biologics (e.g., iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS).
• In-depth knowledge of FDA and international regulatory guidelines, with experience supporting Health Authority inspections.

• PhD, MS, or BS in Biological Sciences, Chemistry, or related field with at least 15+ years of biologics experience in analytical CMC or related area.

Interested candidates should submit an updated CV.

To apply, please call Audrey on 0214297900 or email audrey.mccarthy@peglobal.net with an up-to-date CV.

Note: Our client cannot sponsor visas; candidates must have the correct visa to live and work in Ireland.