Jazz Pharmaceuticals

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

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

• The position reports to the Director MS&T
• The Associate Director Statistics and Data will provide statistical and data interpretation support to the wider MS&T function as well as overseeing and contributing to the overall data strategy and infrastructure support underpinning Jazz’s CPV program.
• The position will act as the subject matter expert regarding all statistical and data analytic needs within the MS&T function in support of the wider Jazz data analytical framework
• The position will be responsible for designing and implementing data harvesting, cleansing and analysis strategies and in conjunction with key partners such as I.S. ensure that Jazz employ the most effective and compliant infrastructure to facilitate this.
• The position will be responsible for ensuring that the level of training amongst the wider MS&T function is conversant with the required activities with regard to Statistical and data analytical techniques.
• The position will be responsible for the day-to-day management the Manager Statistics and Data science MS&T.

Essential Functions/Responsibilities

• Demonstrated technical leadership, proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support / lead process development/ support objectives.
• Lead/Support/Act as SME Contributor for development, maintenance, and continuous improvement of process validation program for all DS and DP manufacturing processes. statistical input to Process Development for defining appropriate statistically significant specifications of new processes.
• Provide support to CMC regulatory requirements for pharmaceutical products and the evolving opportunities offered by application of QbD principles.
• Works to the guidelines set out in the Product team charter.
• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, & influence.
• Take ownership/Support of planning, executing, and reporting for all life cycle management projects and technology transfers in support of process improvement and new product introductions.
• Demonstrated knowledge of a wide range of statistical techniques and tools, with demonstrated experience of applying them with in the pharmaceutical industry.
• Proven ability to identify and implement data analytical enterprise solutions in support of investigation, routine trending, and Continued Process Verification.

Required Knowledge, Skills, and Abilities

• Wide-ranging experience of statistical tools and data analytics that are employed in pharmaceutical industry with a proven record of delivery within the industry.
• Excellent organizational, verbal, communication, presentation, and data analysis skills
• Ability to effectively participate on multi-disciplinary teams.
• Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations
• Proven track record of implementing enterprise systems in support of process trending, investigations, and continued process verification.

Required/Preferred Education and Licenses

• BSc in life sciences or engineering
• Advanced degree (MSc, PhD) desirable
• Minimum 10 years working in the pharmaceutical industry in technical and / or process statistical role.
• Experience working in cross functional teams in a pharmaceutical industry environment.
• Record of achievement in pharmaceutical manufacturing environment
• Project management skills for technical programs is desirable.
• Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable.

Jazz Pharmaceuticals is an Equal Opportunity Employer.