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Veterans Preferred - Senior Director, Product Development - Inhalation

Company: Catalent
Location: Chelsea
Posted on: November 12, 2021

Job Description:

Military Veterans are Encouraged to Apply. Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary

The Senior Director of Product Development - Inhalation is responsible for providing operational, scientific, and technical leadership for all Catalent's Inhalation development activities to deliver the Inhalation business goals. The role is a catalyst for growth and lays-out strategic plans in future development technologies to continuously make Catalent differentiated in the market and able to on-board customer products of added value.

As a leader, you will enhance/grow the technical and intellectual capabilities of the site to establish stability and promote growth. This role will lead the PD (product development) teams of the sites with inhalation capabilities (Morrisville and Boston) and will work in tandem with the PM (project management) team to assure delivery according to agreements with the clients and offer support to sales, business development, and marketing. Contributions to development programs will be made with a clear awareness and understanding of the sites' Quality & Safety culture.

The role will be based at the Boston, MA site and travel as needed.

The Role

  • Build and lead the Inhalation Drug Product development organization to meet the expanding needs of the Pulmonary and Nasal product pipeline, which includes development, technology transfers and non-GMP pilot scale manufacturing.
  • Establish a clear vision and mission for the PD teams in the inhalation sites to maximize the creation of value from development activities and provide superior customer support.
  • Develops the PD operational plan for the inhalation sites aiming at building and shaping the team as the business grow and expand.
  • Prepares and submits for approval the operational budget for the PD site teams
  • Identifies capital investment requirements, provides insights for decision-making and supports the business case.
  • Establish/enhance internal capabilities for formulation, analytical and process development, building a best-in-class team to design and execute phase-appropriate development activities for products ranging from early to late stage development and up to commercial registration.
  • Accountable for all scientific, strategic, and project planning and execution aspects of the drug product formulation, analytical development and process development, primary packaging development, technology transfer, scale-up, and support of validation activities, based on established goals and project timelines.
  • Responsible for establishing and maintaining high scientific and technical standards within the group and for all development activities.
  • Monitors regulatory science trends and maintain the PD teams current and involved with applicable global regulations and industry standards for formulation, analytical and drug product development for pulmonary and nasal drug delivery technologies.
  • Participates 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.
  • Collaborates with manufacturing to deliver drug product supplies for clinical development up to commercial registration.
  • Participates actively and constructively cross functionally, leading or participating in matrix teams to develop and execute science related project plans to meet established goals and timelines.
  • Interacts 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).
  • Creates a scientific culture translated in a team able to deliver quality scientific content verbally or written to marketing publications, conferences, or scientific publications.
  • Establishes a strong team of Subject Matter Experts capable of attracting and retaining new customers as well as providing superior value to the customer along the sales process gates.
  • Spearhead of scientific advisory external meetings to constantly monitor technological and scientific developments in the area of inhalation.

    The Candidate

    Education and Experience:
    • Leadership experience in drug development or manufacturing at the manufacturing at the managerial level, with emphasis in development, technical transfer and pilot scale manufacturing.
    • Masters or Ph.D. in pharmaceutics, chemistry, biological sciences or other related scientific discipline or equivalent in experience
    • Minimum of 10 years-experience in pharmaceutical research and development with a proven track record of strong leadership

      Knowledge, Skills and Abilities:
      • This role must site on-site at the Chelsea, MA (Boston) location (relocation support available) with availability to travel to Morrisville, North Carolina.
      • Expertise within the inhalation / respiratory space, in particular in dry-powder inhalation (spray-drying experience preferred).
        • Expert knowledge in scientific principles and concepts with a strong consultative, but 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 and tactics to meet regulatory milestones.
        • Ability to align priorities and communicate effectively with different stakeholders in a matrix organization.
        • Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings.
        • Works directly with Business Development to win new business (conference calls, new customer meetings, some travel).

          The position requires an individual who is at an advanced level with the Catalent leadership competencies:
          • Passion for Excellence
          • Engages & Inspires
          • Invests in Customers' Success
          • Delivers Innovative Solutions
          • Builds Collaboration & Teamwork
          • Drive Growth

            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.

            Catalent is committed to the health and safety of its employees, visitors and the customersand patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

            personal initiative. dynamic pace. meaningful work.
            Visit to explore career opportunities.

            C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 . 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 for us to investigate with local authorities.

Keywords: Catalent, Chelsea , Veterans Preferred - Senior Director, Product Development - Inhalation, Executive , Chelsea, Massachusetts

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