Job Title:
ASL Scientific Director – Contractor, Analytical Strategy & Lifecycle (Analytical CMC)
Duration: 1
2 months
Location:
Cruiserath, Dublin
Working hours:
39 hours per week
Onsite requirements:
Hybrid (50/50 hybrid policy
Engagement Type:
Contract via Ltd company
Day Rate / Hourly rate:
Competitive day rate
Legal Right to Work:
Applicants must have the legal right to work in Ireland. Visa sponsorship is not available for this role.
Job Overview
Atrium Global is delighted to be supporting our client, a leading global biopharmaceutical company, in the appointment of a Scientific Director of Analytical Strategy & Lifecycle. This pivotal role focuses on developing, managing, and executing analytical CMC strategies to transition late-stage assets through commercialisation and to support lifecycle management of commercial products.
This senior individual contributor position requires deep expertise in biologics analytical sciences and strong technical writing skills to support regulatory submissions and global filings. You will operate as a subject matter expert, contributing scientific and regulatory leadership across assets while delivering high-quality outcomes independently at the highest technical standards.
RESPONSIBILITIES
* Develop and execute analytical CMC strategies for late-stage assets transitioning to commercialisation.
* Lead design, authorship, and critical review of regulatory and technical deliverables including:
* Justification of Specifications (JOS)
* Analytical Comparability Protocols and Reports
* Scientific Briefing Documents
* Responses to Analytical Health Authority Questions
* Provide scientific expertise for lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.
* Serve as subject matter expert in analytical sciences, advising cross-functional teams and aligning with regulatory expectations.
* Partner with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure robust execution of strategies.
* Provide leadership during analytical troubleshooting, method updates, validations, and tech transfers.
* Ensure compliance, clarity, and accuracy in all technical deliverables.
* Operate as a senior independent contributor, proactively driving execution of analytical control strategy.
REQUIREMENTS
* 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
* Reference standard strategy
* Proven track record in authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses).
* Experience in providing strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and managing health authority communications (IRs, FUMs, PMCs).
* Strong technical writing and communication skills with the ability to translate complex science into clear regulatory language.
* Ability to influence and drive alignment across matrix teams without direct authority.
* Solid understanding of analytical methods commonly applied to biologics (iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS, etc.).
* In-depth knowledge of FDA and international regulatory guidelines, with significant experience supporting Health Authority inspections.
* Education: PhD, MS, or BS in Biological Sciences, Chemistry, or related discipline with 15+ years' biologics experience in analytical CMC or related field.