The Director of Biological Process Development (Drug Substance) will provide scientific and administrative direction for the development of biological process technology to support manufacture and development as well as preclinical and clinical studies of biological Drug Substances (DS). This position has high accountability for technical decision-making and will interface with senior levels in the organization in developing strategy based on technical opportunities. In addition, the Senior Director will be responsible for independent action on a variety of initiatives ranging from support of regulatory filings and interactions with Regulatory Agencies (in support of Regulatory Affairs) to negotiation of business arrangements with contract research organizations (CROs). This position has a high degree of project autonomy and also has budget and project management accountability for all DS process development programs in the Biologics Development group. It is also responsible for the overseeing of all clinical DS manufacturing.
The Director will work with the Quality, Regulatory and Supply Chain organizations to ensure that our products meet the highest standards for quality and supply and ensure processes being developed represent commercially practical quality and process controls. This position reports to the Head of Biologics Product Development.
- Define appropriate process technology for quality and regulatory controls for Drug Substance and critical intermediates.
- Oversee process scouting, qualification and validation in accordance with appropriate regulatory requirements (FDA at a minimum, EMA a plus)
- Oversees all biologics DS process development and clinical manufacturing.
- Manage contract process development. Oversee work flow, progress, and milestone achievements
- Conduct process/product risk assessments and use their output to design development and characterization studies. Organize/interpret data and consequent mediation of risk.
- Ensure practices and procedures in GXP assays data analysis are GXP compliant.
- Prepare, review, and revise SOPs for process characterization and development.
- Write/review process development reports as well as applicable sections of regulatory filings (IND, IMPD, BLA, etc.).
- Prepare required briefing papers for use in Agency meetings on critical product issues and, as needed, negotiate directly with the Agencies on issues related to product profile or manufacturing process.
- Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
- This position requires proven abilities and skills in leadership, project management and working in cross-functional work teams.
- Responsible for technology transfer for process scale up and manufacture.
- Responsible for preparing budgets and project plans for process development program and keeping them on track.
- Contributes to the technical and strategic leadership of the Technical Operations department.
- 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.
Required Knowledge, Skills, and Abilities
- At least 8 years of hands-on experience in GMP process development and validation (previous managerial experience a plus) for production and purification of Biological Drug Substances.
- Experience in characterization of a variety of biologics and in design and execution of effect of variable studies (factorial design) to identify process boundaries and critical process parameters.
- Experience in managing process development from Phase 1 to post-approval
- Experience managing contract process development for biologics
- Working knowledge of CMC regulatory and quality requirements for Phase 1 through post approval, including the associated change management and reporting.
- 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, the data, and applicable business and strategic issues
- Proficiency in addressing regulatory issues with respect to Drug Substance profile or manufacturing process. Can prepare briefing papers for use in Agency meetings and help negotiate on critical issues.
- Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
- Excellent written and verbal communication skills with ability to multi-task.
Required/Preferred Education and Licenses
- PhD degree in Biology, Chemistry/Chemical Engineering, or a related discipline with 8 plus years experience
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.
- Requirements associated with international and domestic business travel.
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.
- Periodic business meetings and trade shows 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.