Associate Director Biologics Development Formulations
Posted on May 14, 2019 by Jazz Pharma
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.Responsibilities:
Jazz Pharmaceuticals is seeking an Associate Director of Biologics Development Formulations to join our Biologics development team. The successful candidate will bring scientific and technical knowledge to the organization and support and manage elements of programs at various stages of development and in commercial manufacture. This is a broad role where the successful candidate will support development and subsequent manufacturing of biological formulations and drug product development. Since most of the development and manufacturing functions are performed outside the company, management of CMOs and CROs is a critical aspect of the job and will include frequent visits to contractors depending on the intensity of ongoing activities. The candidate will be able to recommend appropriate analytical methods and to interpret analytical data to understand process impact and measure process consistency. The candidate will design and manage in-process stability studies and interpret stability data to establish in-process and DP storage times and limits. The candidate will design, manage and support process characterization studies and develop control strategies for process validation. The candidate will support process investigations and help determine root cause of excursions during development and commercial manufacturing. Other responsibilities include cross-functional team membership, authoring technical protocols and reports, and writing/supporting CMC sections of regulatory dossiers. The role involves significant cross functional collaboration with other functions, including Research and Development, Manufacturing, Regulatory and Quality, to ensure processes have a strong regulatory and technical foundation as well as being robust and well-controlled. The role is both project and operations oriented that requires an ability to help drive and deliver elements of multiple projects running concurrently and apply current technologies. The position reports to the Senior Director, Process Development, Biologics.
- Manage and support development, scale-up, production and technical transfer of formulations/processes within or between CMO's.
- Debottleneck and rationalize processes to optimize processes consistency, yield, and robustness.
- Generate, treat and analyze experimental data to support process observations/hypotheses.
- Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
- Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND, BLA, and post marketing commitments).
- Work effectively with team members and contractors both in person and remotely.
- Provide direction, support, and corrective action as needed.
- Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
- Have a high level of scientific curiosity and keep informed of technical developments within the industry by attending conferences and reviewing papers thus advocating a culture of continuous improvement.
- International travel of up to about 2 weeks at a time will periodically be required
Required Knowledge, Skills, and Abilities
- In depth understanding of formulations, process development, validation and manufacturing.
- In-depth understanding of primary, secondary and tertiary protein structure and post translational modifications.
- Knowledge and experience of working with statistical programs (Minitab, JMP) for design and analysis of experiments.
- Leadership and demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
- Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD.
- Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity.
- Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement.
- Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost target.
- Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics.
- Experience in defending processes, procedures and investigations during FDA/EMA inspections - experience with preparation for PAI's and inspection support a strong plus.
- Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others.
Required/Preferred Education and Licenses
- Ph.D. with 6 plus years or Master's Degree with 8 plus years in Biology/Chemistry/ Pharmacy
- 7+ years of relevant biological formulations development, process development and manufacturing experience with a strong record of achievement.
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.