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.
The Associate Director (AD) of Formulation & Fill Finish Process Development will provide scientific evaluation and direction for the development and validation of patient convenient formulations and robust aseptic fill finish processes for liquid and lyophilized biologics. This position requires solid understanding of aseptic processing principles as applied to parenteral sterile liquid and lyophilized drug product manufacturing, hands-on experience with the use of multivariate process analytics and statistical or other experimental design techniques (MVA, DOE, QbD) to drive complex, technical workflows to ensure successful process unit operations integration with the product formulation and delivery device requirements. In depth knowledge of scale down models and design of edge of failure experiments simulating compounding, mixing, sterile filtration and filling operations for both liquid and lyophilized dosage forms is required. Experience manufacturing high concentration, viscous biologics is a plus. Additional requirements include solid experience characterizing process and container closure parameters ranges, critical for fill finish operations of combination products, demonstrated record successfully developing and outsourcing fill finish processes from early stage to commercialization including life cycle management, experience in supporting validation campaigns, etc. This position has accountability for technical decision-making and will be a major contributor to the writing of technical development reports as well as global regulatory submissions. The AD will be responsible for Drug Products manufacturing for clinical campaigns according CMC project development plan, timeline and resources. The Associate Director will work with the Clinical, Quality, Regulatory, and Supply Chain organizations to ensure that our products meet the highest quality and supply standards. This position reports to the Senior Director of Biologics Drug Product & Device Development.
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
Description of Physical Demands
Description of Work Environment
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.