Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
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.
The Jazz Pharmaceuticals Athlone manufacturing and Development facility is an integrated pharmaceutical operation encompassing drug product manufacturing and packaging. The site was built and licensed in 2016 and currently manufactures two commercial products. The site also provides technical support to many products in development, clinical investigational medicinal products and commercial products manufactured in CMOs.
The site is extending the scope to further support multiple commercial products, clinical supplies as well as other manufacturing operations completed externally. The Technical Services function is a collaboration between Technical Services, Process Engineering and Laboratory Services, and supports activities for research/early development programs, late stage development programs, and commercial products providing solutions to various stakeholders across the organization.
The Technical Service Manager will oversee a process and analytical developmental laboratory that will support activities for research/early development programs, late stage development programs, and commercial products, providing solutions to various stakeholders across the organization. The manager will be responsible for overseeing the activities in the Technical Services Laboratory and will work closely with site technical, analytical and operations teams to achieve the site and organisational goals. The role will also work closely with corporate Process Development (PD), Manufacturing Sciences (MS), New Product and Technology Introduction (NPTI) and also other Jazz manufacturing sites to deliver best in class technical (process and analytical) solutions supporting product supply to patients.Essential Functions
Required Knowledge, Skills, and Abilities
- Set-up and take a leadership role within the Technical Services Laboratory on-site providing solutions for technical issues and providing continuous improvement for processes.
- Source, procure and maintain equipment for process and analytical activities within allotted functional budget.
- Develop knowledge and set-up the Technical Services laboratory for new pharmaceutical manufacturing processes/ analytical activities as required in line with Jazz business objectives.
- Oversee matrix teams comprising of analytical and/or operations personnel to execute projects in line with global commitments and site objectives.
- Lead and participate in cross-functional teams on identifying root cause and corrective actions for process deviations utilizing best practice problem solving and continuous improvement methodologies.
- Execute process and analytical studies and engage with internal stakeholders and strategic external partners to deliver solutions to technical issues.
- Work closely with the on-site GMP laboratory and collaborate with on-site functions to deepen technical and scientific understanding of products and processes.
- Collaborate with Process Development (PD) and Manufacturing Science (MS) functions to design and execute process and analytical optimizations and/or formulation development for products.
- Design and implement technical studies and programs as appropriate to support investigations and product improvements.
- Perform analytical method optimizations and development as appropriate.
- Clearly and effectively communicate proposals, DOE's and study results, written and verbal, to technical and non-technical audiences.
- Author and/or review technical reports, test procedures, run sheets as appropriate.
- Establish/confirm specifications for raw materials, process parameters, process controls and equipment, finished products as appropriate.
- Working with the Technical Services function, develop and apply statistical process control systems in collaboration with Manufacturing and Quality functions.
- Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
- May be required to carry out duties in the Laboratory Services, Operations and wider Technical Services functions as required based on business needs
Required/Preferred Education and Licenses
- Advanced level of technology experience required, broad experience across drug manufacturing technologies and dosage forms preferred. Broad knowledge in pharmaceutical technologies and dosage forms (small molecule Drug Product development and manufacturing, Low Bioburden manufacturing and complex liposomal product are all beneficial).
- Direct experience with process and analytical development. Experience with respect to formulation development is an advantage.
- Proven track record and demonstration of technical proficiency for resolving complex issues including technical writing to support regulatory filings and submissions.
- Ability to plan and execute process studies and perform associated analytical testing (e.g. perform excipient compatibility studies, perform impurity isolation and characterization, formulation coating studies, small scale reactions and associated analysis, IVIVC studies, forced degradation studies etc.)
- Experience in managing contract laboratories (for complementary process and analytical activities)
- Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering.
- Demonstrated experience of technical writing of complex issues to support regulatory submissions and inspections.
- Broad experience in analytical sciences and in particular HPLC method troubleshooting.
- Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought.
- Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a 'go-to' expert across the business.
- Highly flexible, works well in a team and has necessary skills to organise, communicate, influence and lead.
- 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 capability in establishing collaborative working relationships at all levels, regardless of seniority.
- Advanced degree in Chemistry, Pharm. Sci., Biochemistry, Engineering or related field, or equivalent combination of education and work-related experience required
- A minimum of 7 years direct experience in pharmaceutical/biotech industry.
Jazz Pharmaceuticals is an Equal Opportunity Employer.