Reporting to the Head, New Product & Technology Integration, this role is responsible for managing Technical Operations’ due diligence assessments of new product candidates. This position will work closely with the Corporate Development department to ensure progress on the assessment is in sync with deal requirements. A related responsibility is coordinating Technical Operations planning for the integration process post-deal and for the implementation of that plan after closure. This is a critical liaison function between Corporate Development, Technical Operations, and the potential partner/licensor.
This role is also responsible to evaluate new technologies which may have a potential to facilitate Technical Operations’ development/manufacturing programs or life cycle management (LCM) of Jazz Products and to assess new product concepts which may be applicable to Jazz business interests. For technologies or products deemed worthy of proof of concept (POC) assessment, this role is responsible to design and implement studies which will elucidate value and give insight into the development approach.
This role will depend heavily on resources external to NPTI, primarily contractors and consultants, and will involve significant coordination/collaboration with Technical Operations, Regulatory CMC, Commercial, Legal (both IP and Contracts), and Finance and leadership of this team in a matrix fashion for CMC. The position has high accountability and visibility in terms of technical assessment, coordination inside and outside of Jazz, innovation and decision making
- Conduct due diligence in partnership with Corporate Development, maintaining pace, depth of diligence and engagement of internal resources. Provide feedback and strategic direction to improve efficiency of diligence process.
- Direct and oversee (as a matrix manager) diligence programs, coordinating inputs from expert consultants, Technical Operations and other departments as appropriate to the product / stage of diligence.
- Create and maintain assessment documents for each deal candidate, comprising inputs from consultants and Jazz functions with respect to competence/compliance and risk for production technology, CMC approvability and robustness of supply chain.
- Develop and maintain summary assessment covering major milestones for development, major product/process risks and potential mitigations for deal candidates and option programs.
- Develop and maintain knowledge of new pharmaceutical manufacturing technologies & processes as required in line with Jazz business objectives
- As a Matrix manager, plan, oversee and monitor programs to integrate deal products/companies into existing functions and workflows within Technical Operations
- Engage, negotiate with, and maintain effective working relationships with potential/actual partners regardless of size or cultural background.
- Develop and maintain a portfolio of consultants covering a range of technical competencies apropos to due diligence and technology assessment.
- Create checklists, playbooks, templates and other tools to standardize and improve the diligence and integration processes.
Required Knowledge, Skills, and Abilities
- Experience in managing drug substance/drug product process and device development from Phase 1 to post-approval.
- Experience in a variety of both large and small molecules and the associated regulatory approval processes and challenges. Knowledge of global requirements highly desirable.
- Proven ability to manage technical assessment outside of specific background, engaging technical expertise and coordinating functional inputs to achieve desired result.
- Experience with diligence processes at various stages and with various technologies. Experience in integration programs highly desirable.
- Deep technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task
- Clear technical writing, including sections of Module 3 and briefing documents for regulatory bodies and excellent oral communication skills are required.
- This position requires proven skills in leadership, project management and working in cross-functional work teams, including sensitivity and adaptability to cultural norms and preferences. Significant experience as a matrix manager is required.
Required/Preferred Education and Licenses
- Bachelors of Science, Master’s or Ph.D. degree in the fields of Pharmaceutical Sciences, Chemical/Biomedical Engineering, or a related field is required.
- At least 15 years of hands-on experience in drug development and validation, preferably in pharmaceutical or biotech company. This must include experience in program outsourcing and management of CMOs/CROs.
- The ideal candidate will have experience from early feasibility to post-commercialization and one or more areas of deep technical knowledge.
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.