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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 (https://www.catalent.com/our-locations/north-america/morrisville-rtp-usa/) , 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 scientific principles and concepts with a strong consultative, results-oriented approach

• Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity

• Experienced in most aspects of drug development and lifecycle support and able to develop useful strategies to meet regulatory milestones

• Works directly with Business Development to win new business (conference calls, new customer meetings, some travel)

• 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.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401k match and paid time off accrual

• Medical, dental, and vision benefits effective day 1 of employment

• Tuition reimbursement

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .