Johnson Matthey (‘JM’) is a global leader in science that enables a cleaner and healthier world. With over 200 years of sustained commitment to innovation and technological breakthroughs, we improve the function, performance and safety of our customers’ products. Our science has a global impact in areas such as low emission transport, pharmaceuticals, chemical processing and making the most efficient use of the planet’s natural resources. Today more than 14,000 Johnson Matthey professionals collaborate with our network of customers and partners to make a real difference to the world around us.
The Head of ANDA Program Management is responsible for high-level oversight of all aspects of Johnson Matthey’s Health Generics ANDA pipeline from dosage form development through ANDA submission and approval. Develops and ensures execution of detailed project plans through coordination of project managers and associated teams responsible for each individual contributing functions, internally and externally, in order to establish budget and timelines. Manages expectations and responsibilities across all functions, has a deep understanding of ANDA key interdependencies including identification of risk and mitigation steps.
- Responsible for the virtual development of a vertically integrated, generic portfolio of products. Should be well versed in working with controlled substances, high potent APIs, and finished dosage forms including solid and liquid orals, parenterals, and sterile ophthalmics. Responsible for risk management, scheduling and control, tracking, reporting, and budget management.
- In conjunction with the Director of Finished Dosage Forms, oversees Contractor Management program (CDMOs, Contract Analytical Labs, etc.) including preparation of project specific Request for Proposals, obtains bids, negotiates contracts, and makes CDMO placement decisions based on overall costs, timing, and commercial costs of goods.
- Prepares and manages project budgets; ensures efficient and cost-effective use of resources.
- Identifies and qualifies CDMO organizations suitable for conducting specific dosage form work on behalf of JM
- Through collaboration with subject matter experts from each contributing function (API development, final dose formulation, bioequivalence, regulatory affairs, manufacturing/supply chain, legal, commercial) is accountable for delivery of project plans, identifying project risks, including probability and impact, develops mitigation and contingency plans.
- Communicates the overall scope, timing, funding requirements, and resource requirements to develop finished dosage forms and provides clear and frequent communication of overall progress and achievement of milestones to all project team members and key stakeholders in a matrix management environment.
- Must have the ability to successfully communicate and interact at and with all levels within the organization and outside third parties.
- Maintains decision documentation, as it relates to project timelines and co-dependencies, and coordinates solutions development.
- Ensures proper identification of project phase dependencies when developing workflows, critical paths and milestones.
- Maintains “overall picture” of the finished dosage form program and negotiates resolution to potential issues to prevent delay to project timeline.
- Escalates risks and issues to relevant stakeholders; leads delivery of tactical and achievable mitigation & contingency planning.
- Responsible for implementation of Company/Division/business unit policies, practices, and procedures.
- Other duties as assigned.
Are you the ideal candidate?
- BS in Chemistry with 10-15 years pharmaceutical dosage form development experience
- MS or PhD Pharmaceutical Science preferred with 5-7 years experience in Pharmaceutical Science
- 3-5 years Project Management
- PMP or PgMP Certification preferred
- Demonstrated experience dealing with and managing CDMO organizations to achieve regulatory filing timelines.
- Able to demonstrate previous ANDA Program or Project Management experience required including sourcing of API, drug formulation, bioequivalence stud(ies), definition of regulatory strategy, quality assurance compliance, manufacturing of finished dose forms.
- Thorough understanding of all phases of pharmaceutical drug and process development, as a minimum for US market, other market regions an advantage.
- A “self-starter” with a proven ability to work independently in an environment with significant ambiguity.
- Must possess strong leadership, influencing, organizational, prioritization and project management skills.
- Demonstrable experience working in a cGMP environment with frequent interactions with technical staff.
- Demonstrated success managing multi-faceted projects in a matrix environment and leading without formal authority.
- Experience in report generation budget tracking and timeline (e.g. MS Project) management tools.
- Demonstrated excellent oral and written communication and presentation skills are required.
- Superb relationship management skills are required in order to influence cross functionally and external third parties.