ASL Scientific Director
3 weeks ago
One of the top 10 best companies to work in Ireland is looking for an ASL Scientific Director for their large-scale new facility in Dublin. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
What you'll do- Lead analytical CMC strategy for late-stage assets moving toward commercialisation.
- Author and review key regulatory documents, including JOS, comparability protocols, briefing documents, and health authority responses.
- Provide scientific oversight for commercial product lifecycle management—specifications, method lifecycle, reference standards, and comparability.
- Act as a subject matter expert, guiding cross-functional teams and ensuring regulatory alignment.
- Drive execution and troubleshooting, offering leadership in method updates, validations, tech transfers, and ensuring high-quality deliverables.
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with extensive biologics experience within analytical CMC / relevant field, respectively.
- Extensive expertise in analytical CMC for biologics, including specification setting, comparability strategy, method lifecycle, and reference standards.
- Proven ability to author complex regulatory documents and contribute strategically to global submissions and health authority interactions.
- Strong communication and technical writing skills, capable of translating complex science into clear regulatory language.
- Effective cross-functional leadership, influencing matrix teams and driving alignment without direct authority.
- Deep understanding of analytical methods and global regulatory standards, with experience supporting inspections and compliance.
If this role is of interest, please apply now
#J-18808-Ljbffr
-
Dublin, Dublin City, Ireland Novartis Ireland Full timeGlobal Portfolio Scientific Communications DirectorSummary: Leads development of scientific communication platform (scientific statements, lexicon, and scientific narrative) aligned with therapeutic areas for launch assets and disease areas, including publication and medical education strategy and execution.About The RoleLeads the development,...
-
Dublin, Dublin City, Ireland Novartis Ireland Full time4 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.SummarySupport the development of scientific communication platform (scientific statements, lexicon, and scientific narrative) aligned with Therapeutic Area and scientific communications for assigned launch asset/disease area including publication...
-
Clinical Development Director
3 weeks ago
Dublin, Dublin City, Ireland Novartis Ireland Full timeJoin to apply for the Clinical Development Director - Renal role at Novartis IrelandOverviewThe Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit leads the strategic planning and end-to-end management of the assigned clinical program(s). As the CDD in the Renal therapeutic area, you will have oversight of the clinical...
-
Group Clinic Director: Ireland
4 weeks ago
Dublin, Dublin City, Ireland Sims Ivf Full timeOverviewCurated Partners are delighted to be working in partnership with Sims IVF to appoint a Group Clinic Director in Ireland.Purpose of the role:The Group Clinic Director will assume overall commercial performance, operational and leadership responsibility for all Virtus Health IVF clinics across Ireland.This will include responsibility for general...
-
Group Clinic Director: Ireland
4 weeks ago
Dublin, Dublin City, Ireland Sims IVF Full timeOverviewCurated Partners are delighted to be working in partnership with Sims IVF to appoint a Group Clinic Director in Ireland.Purpose of the role: The Group Clinic Director will assume overall commercial performance, operational and leadership responsibility for all Virtus Health IVF clinics across Ireland. This will include responsibility for general...
-
Site Quality Head Swindon
3 weeks ago
Dublin, Dublin City, Ireland ThermoFisher Scientific Full timeOverviewBusiness Job Title: Site Quality Director SwindonGroup/Division: Pharma Services Group / Drug Product Division - Swindon SiteThis role is based in Swindon, UK, we are open to candidates from the EMEA region who are willing to relocate.Position Summary:As the Site Quality Director, you lead the CDMO Quality and Regulatory team, ensuring outstanding...
-
Protocol & Clinical Program Excellence Director
4 weeks ago
Dublin, Dublin City, Ireland Novartis Ireland Full timeProtocol & Clinical Program Excellence DirectorJoin to apply for the Protocol & Clinical Program Excellence Director role at Novartis IrelandContinue with Google Continue with GoogleProtocol & Clinical Program Excellence DirectorJoin to apply for the Protocol & Clinical Program Excellence Director role at Novartis IrelandGet AI-powered advice on this job and...
-
Clinical Development Director
4 weeks ago
Dublin, Dublin City, Ireland Novartis Ireland Full timeOverviewThe Clinical Development Director (CDD) Neuroscience and Gene Therapy is the clinical/scientific and clinical development expert who provides leadership and support to clinical development deliverables and activities within a defined global clinical development program and/or global clinical trial (e.g., clinical development plan, clinical trial...
-
Director - Analytical CMC
3 weeks ago
Dublin, Dublin City, Ireland PE Global Full timeOverviewPE 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...
-
Medical Director, ILD-PH
3 weeks ago
Dublin, Dublin City, Ireland Gossamer Bio Full timeThe Medical Director, ILD-PH Europe serves as a strategic medical and scientific expert within the organization, responsible for shaping and executing medical affairs strategies that drive therapeutic value, scientific leadership and enrolment in clinical trials. This role provides medical expertise across key medical affairs activities, including healthcare...
