Senior Director, Biological Analytical Development

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to

transform the lives of patients and their families. We are dedicated to developing

life-changing medicines for people with serious diseases - often with limited or no

therapeutic options. We have a diverse portfolio of marketed medicines, including leading

therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development

advancements across our robust pipeline of innovative therapeutics in oncology and

neuroscience. Jazz is headquartered in Dublin, Ireland with research and development

laboratories, manufacturing facilities and employees in multiple countries committed to

serving patients worldwide. Please visit

www.jazzpharmaceuticals.com

for more information.

The Senior Director, Biological Analytical Development is responsible for providing both leadership and hands-on technical expertise for analytical aspects of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high-quality methods, specifications, and regulatory documentation to enable clinical development and regulatory submissions. The role can manage a team as well as external partners / CMOs, balancing mentorship and oversight with active participation in experimental design, data interpretation, and issue resolution.

Essential Functions

Provide scientific and operational leadership of biological analytical development activities from early stage through validation and transfer to QC.

Act as both leader and contributor : oversee external partners and direct reports, while also engaging in hands-on work such as reviewing data, drafting regulatory sections, and troubleshooting technical issues.

Define and implement phase-appropriate analytical strategies for biologics drug substance, drug product, intermediates, and critical components.

Oversee method scouting, qualification, validation and tech transfer in accordance with appropriate regulatory requirements

Ensure robust stability programs, reference standards, and specifications are developed and maintained.

Conduct and / or oversee characterization studies, comparability assessments, and product risk assessments.

Support and mentor a team of scientists; provide coaching while contributing directly to program deliverables.

Manage interactions with CDMOs and testing labs, ensuring timelines and quality standards are met.

Draft and review regulatory documents (IND, IMPD, BLA / MAA) and contribute to agency meeting preparations.

Partner with Regulatory CMC, Quality, and other functions to ensure compliance with global regulations.

Participate in the Analytical Development Leadership Team and contribute to strategy setting across modalities.

This job requires occasional domestic and international travel to visit contractors for project reviews or to support ongoing development

Required / Preferred Knowledge, Skills, and Abilities

At least 10 years of hands-on experience in biologics analytical development and method validation (previous managerial experience a plus) for Analytical Development from Phase 1 to approval.

Experience in characterization of biologics and in generating data analysis reports for Reg filings and Analytical Comparability Assessments

Experience managing contract development

Experience in addressing regulatory queries and authoring analytical sections of IND / IMPD or BLA / MAA.

Preferred-Experience leading a CMC Development Team

Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.

Excellent written and verbal communication skills.

Required / Preferred Education and Licenses

The position requires a B.Sc. or M.Sc. in Analytical Chemistry / Science / Biotechnology / Science / Engineering or related field

Jazz Pharmaceuticals is an equal opportunity / affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here : https : / / careers.jazzpharma.com / benefits.html .