• Manager, Process Development

    Catalent Pharma SolutionsMorrisville, NC 27560

    Job #1208151379

  • Job DescriptionPosition 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 hereThis employee will report directly to the Director, Pulmonary and Nasal Product DevelopmentThe Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.The Role+ Plans, directs and executes the development of processes for the manufacture of pharmaceutical products in a GMP environment+ Leads the technical transfer of manufacturing processes into GMP production+ Supplies technical inspiration, leadership and consultation to professional co-workers+ Plans, conducts and directs scientific work on extremely complex projects necessitating the origination and application of new and unique approaches+ Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis and operating procedures+ Reviews, technical documents for accuracy, thoroughness and regulatory compliance+ Identifies and independently drives department level improvementsThe Candidate+ Doctoral degree, Master's degree, or Bachelor's degree in chemistry or closely related physical or life science from a four-year college/university or equivalent education with at least 10 years' related experience+ Candidates must have a minimum of 3 years previous supervisory experience in a Pharmaceutical GMP environment+ Candidates must have a minimum of 5 years previous experience in the development of processes for the manufacture of pharmaceutical products in a GMP environment+ 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 while having the ability 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+ Recognized by internal clients, external customers and direct reports as a subject matter expert with high personal credibility+ Ability to work effectively under pressure to meet deadlinesPosition Benefits+ Medical, Dental, Vision and 401K are all offered from day one of employment+ 19 days of paid time off annually + 7 paid holidaysLeadership Competencies for Performance and Development+ Leads with Integrity and Respect+ Delivers Results+ Demonstrates Business Acumen+ Fosters Collaboration and Teamwork+ Champions Change+ Engages and Inspires+ Coaches and DevelopsCatalent 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 ~~~/careers to explore career opportunities.Catalent 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.Catalent = Catalyst + TalentYour 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 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. Catalent 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, or protected veteran status. 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 along with the job number and title to ~~~. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.