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Associate Director, Biological Analytical Development

Overview

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.

Position Profile

Jazz Pharmaceuticals is seeking an Associate Director of Biological Development to join our Biologics Product Development team. The Associate Director of Biological Development will provide scientific and administrative direction for the development and validation of analytical methodology to support manufacture and development as well as preclinical and clinical studies of biologic products. It will partner with the commercial organization and sites. This position has accountability for technical decision-making. The Associate Director will be a major contributor to the writing of technical development/validation reports as well as regulatory submissions. The Associate Director will work with the Quality, Regulatory and Supply Chain organizations to ensure that our products meet the highest standards for quality and supply. In addition, this position has responsibility to work as a development interface with Jazz sites/CMOs as appropriate. This position reports to the Sr. Director, Biological Analytical Development.

Job Requirements:

  • Manage contract and in-house method development. Oversee work flow, progress, and milestone achievements.
  • Contribute to project/department budgets and forecasting.
  • Define appropriate analytical methodology for quality and regulatory controls for Drug Substance, Drug Product, and critical intermediates.
  • Oversee method scouting, qualification and validation in accordance with appropriate regulatory requirements (FDA at a minimum, EMA/PMDA a plus).
  • Interface with Global Manufacturing Supply to ensure methods being developed represent commercially practical quality and process controls.
  • Design and manage appropriate stress and stability studies during development, and organize analysis and trending of data.
  • Design and manage structural characterization studies and support formulation development.
  • Ensure practices and procedures in GXP assays data analysis are GXP compliant.
  • Prepare, review, and revise SOPs and test methods.
  • Write/review method development reports and validation protocols/reports.
  • Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
  • Provide strategic input and interpretation support for clinical and non-clinical studies (e.g., toxicology and pharmacokinetics studies), as needed.
  • This position requires proven abilities and skills in leadership, project management and working in cross-functional teams.
  • This job requires occasional domestic and international travel to visit contractors for project reviews or to support ongoing development operations. During production campaigns, trip duration could be as much as 14 working days.



Essential Qualifications:

  • Masters/PhD degree in Analytical Chemistry/Chemistry/Chemical Engineering, Pharmacy, or a related discipline.
  • At least 7 years of hands-on experience in GMP biologic product analytical method development and validation.
  • Excellent written and verbal communication skills both face to face and via teleconferences.
  • Excellent critical thinking and problem solving abilities. Must be capable of grasping complex technical issues and making sound decisions based on the fundamental principles of the technology and the data.
  • Excellent interpersonal and collaboration behaviors with ability to influence without authority.
  • Experience managing contract analytical development for biologics through CMO (preferred).
  • Working knowledge of characterization of a variety of biologics by orthogonal methods.
  • Experience in managing method development during Phase 1 to post-approval.
  • Working knowledge of CMC regulatory and quality requirements for Phase 1 through post approval, including the associated change management and reporting.
  • Experience contributing to regulatory submissions.
  • Demonstrates technical proficiency, creativity and independent thought.



Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.



Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.
  • 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.



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.

Associate Director, Biological Analytical Development

Palo Alto, CA
Full Time

Published on 09/06/2019