Catalent Pharma Solutions Director, Product Development – Inhalation (Chelsea, MA) in Massachusetts
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Position SummaryThe Director, Product Development - Inhalation 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 development and on boarding of technologies.As a leader, you will enhance/grow the technical and intellectual capabilities of the site to establish stability and promote growth. The Director will lead the PD team and work in tandem with PM team to assure delivery according to agreements with the clients and offer support to sales (BD) and marketing. Contributions to development programs will be made with a clear awareness and understanding of the site’s Quality & Safety culture.
Build and lead the Drug Product development organization to meet the expanding needs of the Pulmonary and Nasal product pipeline.
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 early to late stage development and 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.
Responsible for establishing and maintaining high scientific and technical standards within the group and for all development activities.
Will maintain currency with applicable global regulations and industry standards for formulation and drug product development for pulmonary and nasal drug delivery technologies.
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.
Will collaborate with manufacturing to deliver drug product supplies for clinical development up to commercial registration.
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 and the inhalation pillar, will build and shape the team as the business grow and expand, prepare the budget for the team.
Work in a matrix organization with different stakeholders will require alignment of priorities and communication skills
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).
Education and Experience:
Leadership experience in drug development or manufacturing at the manufacturing at the managerial level
Masters or Ph.D. in pharmaceutics, chemistry, biological sciences or other related scientific discipline or equivalent in experience
10 years experience in pharmaceutical research and development with five years in a Leadership role
Knowledge, Skills and Abilities:
The PD Director must site on-site at the Chelsea, MA (Boston) location (relocation support available)
Expertise within the inhalation / respiratory space
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.
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
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 customers and 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 www.catalent.com/careers 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 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .
Catalent Pharma Solutions
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