Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
Reporting into the Sr. Director, Analytical Development the role will provide scientific and technical leadership at various stages of drug development including analytical method assessment, development, transfer, validation and troubleshooting of methods. The position will lead/support activities for research/early development programs, late stage development programs, and commercial products. Activities may be performed internally or with external vendors. Otherresponsibilities will include cross-functional team membership, authoring and/or reviewing method validation protocols and reports, technical reports, and supporting CMC aspects of regulatory dossiers. The position reports to the Senior Director of Analytical Development.
- Support early stage, late stage and commercial products in analytical sciences
- Lead analytical method development, validation, transfer and stability evaluations
- Vendor management and oversight of workflow, progress and milestones at vendors
- Trouble-shooting of analytical methods
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
- Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings
- Support and ensure a smooth transfer of analytical technologies to contract sites
- Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.
- Broad experience in analytical sciences supporting early stage, late stage and commercial products
- Direct experience with analytical method development, validation, transfer and stability evaluations
- Demonstrated technical proficiency of analytical methodologies for drug substance and drug product
- Experience in regulatory requirements for pharmaceutical products
- Experience in managing contract analytical organizations is highly desired
- Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.
- Excellent written and verbal communication skills with ability to multi-task.
- Demonstrated troubleshooting and problem solving skills
- Up to 25% travelrequired.
Quality System Requirements:
- Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing
Qualifications and Experience:
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experiencerequired
- 6-10 years direct experience analytical development, preferably in a pharmaceutical/biotech industry.