Director, Product Development (PD)

Director, Product Development (PD)

Position Summary

The Director, Product Development (PD) is responsible for providing operational, scientific and technical leadership for all product development activities, which includes customer-focused programs and programs based with other Catalent operations. This also includes strategically planning future site capabilities and on-boarding of new manufacturing technologies. As a leader, the Director, Product Development will enhance and grow the technical and intellectual capabilities of the site to establish stability in the standard development work and promote long-term growth in the quality of science and engineering offered by the Boston site. The Director will lead the PD team and work in tandem with Project Management team to assure delivery according to agreements with the clients. You will also offer support to sales (BD) and marketing and emphasize the leadership of development programs with a clear awareness of the site’s Quality & Safety culture. 

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, with potent filling capacity for up to 100 million capsules annually. 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. With clinical- to commercial-scale spray drying and manufacturing, paired with inhalation development expertise out of our Morrisville/RTP, NC site, the Catalent network can help bring inhaled molecules from any point in development through product launch and beyond.

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

• Build and lead the Drug Product development organization to meet the expanding needs of the Catalent-Boston pipeline. Specific focus on dry powders for pulmonary and nasal delivery and the manufacture of spray dried dispersions for bioavailability enhancement.

• Monitors regulatory science trends and maintains the PD teams work practices with applicable global regulations and industry standards for formulation, analytical and drug product manufacturing process development

• Establish/enhance internal capabilities for formulation and drug product development, building a best-in-class team to design and execute phase-appropriate development activities for products ranging from pre-clinical development up to commercial registration.

• Responsible for all scientific, strategic, and project planning and execution aspects of the drug product formulation and process development, primary packaging development, technology transfer, scale-up, and validation activities, based on established goals and project timelines.

• Will participate in drug product regulatory strategy development through client steering team participation, construction and review components of regulatory filings, and engagement in the New Product Introduction process.

• Work cross functionally, leading or participating in matrix teams to develop and execute project plans to meet established goals and timelines.

• Develop the strategic plan for the site's product development 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, 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.

• All other duties as assigned.

The Candidate

• Onsite at the Chelsea, MA facility

• Bachelors required. Masters or PhD in pharmaceutics, chemistry, biological sciences, or other rlated scientific discipline or equivalent experience preferred

• 10 years experience in pharmaceutical research and development with 5 years in a leadership role in drug development or manufacturing

• Expertise within the inhalation/respiratory space

• Expert knowledge in