Director, Spray Drying Technology Transfer and Scale-up

Catalent • Chelsea, MA

5h • $183,000 - $250,000 • Onsite

About The Position

Director, Spray Drying Technology Transfer & Scale-up Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions in Chelsea, MA is hiring a Director who is an integral part of the senior leadership team with the skills, knowledge and experience to advance spray drying programs. The Director is the spray drying subject matter expert responsible for providing scientific, technical and operational leadership for all spray drying activities. This position is responsible for a wide range of spray drying activities ranging from technical evaluation of new spray drying programs, onboarding new clients, scaling-up from laboratory to industrial scale, analyzing complex data, strategically planning future site capabilities and on-boarding of new manufacturing technologies. As a leader, the Director will enhance and grow the technical and intellectual capabilities of the site to establish spray drying stability while promoting long-term growth. The Director will be a change agent driving a predictable processes and favorable batch outcomes. The Director will lead the team and work in tandem with Project Management team to ensure delivery according to agreements with the clients. The Director will also offer support to Business Development. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for all scientific, strategic, project planning and execution aspects of spray drying drug product formulation, process development, technology transfer, scale-up, and validation activities, based on established goals and project timelines. Build and lead the organization to meet the expanding needs of the Catalent-Boston spray drying pipeline, which includes dry powders for pulmonary and oral solid dose markets. Partner internally and build a best-in-class spray drying team to design and execute phase-appropriate development activities for products ranging from pre-clinical development to routine commercial manufacturing. Champion spray drying life cycle management from product development to commercial operations, including spray drying process development, clinical supply, scale-up, NOR/PAR, and PPQ activities. Advance internal spray drying capabilities for formulation, drug product development and commercialization of spray drying operations. Lead drug product regulatory strategy development through client steering team participation, establishment of documentation for regulatory filings, and implementing changes to spray drying process to enhance performance. Will work cross functionally, leading or participating in matrix teams to develop and execute project plans to meet established goals and timelines. Will develop the strategic plan for the site spray drying offerings. The Director will build and shape the team as the business expands. The Director will prepare and manage the yearly budget for the team. Will interact effectively and transparently with operations and support functions across the site (Quality Assurance, Supply Chain, Manufacturing, Project Management, Finance, Operational Excellence/Continuous Improvement, Commercial Operations, EHS, Human Resources, and Facilities/Engineering). Identifies capital investment requirements, provides insights for decision-making and supports the business case. Other duties as assigned.

Requirements

• Leadership experience in Drug Development, Process Validation and Commercial Manufacturing.
• Bachelors required.
• Masters or Ph.D. in Pharmaceutics, Chemistry, Biological Sciences or other related scientific discipline or equivalent in experience preferred.
• 10 years’ experience in Pharmaceutical Research and Development with five years in a Leadership role.
• The Director must be on-site at the Chelsea, MA (Boston) location with expertise in the inhalation / respiratory / solid dose space.
• Expert knowledge in scientific principles and concepts with a strong consultative, but results-oriented approach.
• Advanced analytical skills for data analysis and decision making
• Experienced in all aspects of drug development and lifecycle support, including the development of regulatory strategies.
• Works directly with Business Development to win new business (conference calls, new customer meetings, some travel).

Nice To Haves

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Responsibilities

• Responsible for all scientific, strategic, project planning and execution aspects of spray drying drug product formulation, process development, technology transfer, scale-up, and validation activities, based on established goals and project timelines.
• Build and lead the organization to meet the expanding needs of the Catalent-Boston spray drying pipeline, which includes dry powders for pulmonary and oral solid dose markets.
• Partner internally and build a best-in-class spray drying team to design and execute phase-appropriate development activities for products ranging from pre-clinical development to routine commercial manufacturing.
• Champion spray drying life cycle management from product development to commercial operations, including spray drying process development, clinical supply, scale-up, NOR/PAR, and PPQ activities.
• Advance internal spray drying capabilities for formulation, drug product development and commercialization of spray drying operations.
• Lead drug product regulatory strategy development through client steering team participation, establishment of documentation for regulatory filings, and implementing changes to spray drying process to enhance performance.
• Will work cross functionally, leading or participating in matrix teams to develop and execute project plans to meet established goals and timelines.
• Will develop the strategic plan for the site spray drying offerings.
• The Director will build and shape the team as the business expands.
• The Director will prepare and manage the yearly budget for the team.
• Will interact effectively and transparently with operations and support functions across the site (Quality Assurance, Supply Chain, Manufacturing, Project Management, Finance, Operational Excellence/Continuous Improvement, Commercial Operations, EHS, Human Resources, and Facilities/Engineering).
• Identifies capital investment requirements, provides insights for decision-making and supports the business case.
• Other duties as assigned.

Benefits

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
• Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Programs including Vacation, banked time, and personal time.
• Employee Reward and Recognition Programs.
• Opportunities for professional and personal development.
• Catalent offers rewarding opportunities to further your career!

What This Job Offers

• Job Type: Full-time
• Career Level: Director