The Head of Process Development has overall responsibility for technical product lifecycle management in the Discovery Labs asset pipeline. This includes preparing the business case, as well as, the oversight and management of technology transfer (new product introductions) into Manufacturing. Developing Life Cycle strategies and plans, including clinical and commercial phases, process improvements and post approval commitments. The individual will be accountable for the successful execution of the corresponding plans in compliance with Agency and Industry Guidance. During the clinical/commercial manufacturing preparation phase, this role will lead the delivery of all pre-run deliverables such as Materials List, Process Transfer Documents, Manufacturing Batch Records, Process Monitoring plans, etc.
• Lead and oversee all process and analytical transfers to and from internal and external business partners.
• Own and execute Quality by Design (QbD) for programs.
• Leverage all of The Center for Breakthrough Medicine’s process development expertise to support late stage clinical programs.
• Responsible for the development schedule adhering to appropriate level of documentation, budget, schedule, and safety commitments.
• Support the commercial function in the assessment of new opportunities and provide appropriate Technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.
• Build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of therapeutic proteins.
• Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
• Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit.
• Evaluate the functional strengths and developmental areas in the Process Sciences team and drive a culture of continuous improvement.
• Manage team of senior managers and professionals within Process Sciences. Hires and develops employees within the department in support of site objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
• Work with internal stakeholders in manufacturing, process development & optimization, project management etc. to facilitate successful customer management.
• Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues.
• Key input into the development of manufacturing platforms and novel technologies.
Experience and Qualifications:
• Ph.D. in biochemical engineering or biological sciences with 15-20 years experience required.
• Solid foundation in the fundamentals of biochemical engineering and cell biology.
• Entrepreneurial experience dealing with customers in product development.
• Working knowledge of cGMPs related to the production of microbial therapeutics.
• Ten to fifteen years of development and scale-up experience.
• Experience with microbial fermentation technologies, protein purification, protein characterization, and downstream processing are essential.
• Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
• Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed.
• Rational persuasion particularly in the discussions with customers.
• Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
• Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions and make decisions.
• Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
• Extremely high levels of initiative and tenacity.
• Excellent oral and written communication skil