Principal Process Scientist
Position Summary
Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Principal Process Scientist has responsibility for product transfer into commercial manufacturing and support after launch. This role is responsible for leading the development of improved product transfer processes and ensuring commercialization of products is effective. Post-launch, the Principal Process Scientist is responsible for leading process improvements, resolving technical issues and leading root cause investigations involving product nonconformance.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
This position is 100% on-site at the Greenville site.
The Role
Collaborate with development scientists and clients as applicable to provide suggestions and guidance to ensure commercial viability, efficiency and quality are considered in process design.
Work closely with all stakeholders in strategic planning to ensure that project activities are progressing according to established timeline.
Act as the primary interface between Manufacturing and the sending organization to drive effective communication and expedient execution at all stages of the project.
Develop commercial records in collaboration with process scientists.
Oversee execution of technical transfer and process improvement batches.
Analyze data from and make recommendations for the commercial process.
Collaborate with Validation group to transfer knowledge and ensure a successful validation campaign.
Provide leadership for technical transfer and post-launch support projects, ensure they adhere to site procedures and where needed make process improvements to the procedures.
All other duties as assigned.
The Candidate
Bachelor's degree in science or engineering with at least 7 years of experience or;
Master's degree in science or engineering with at least 4 years of experience or;
Doctorate degree in science or engineering with at least 2 years of experience.
Experience in pharmaceutical or related field with experience in process development and/or technical transfer in drug manufacturing.
Position requires the ability to occasionally lift 40 lbs unassisted, and occasionally push and pull a maximum of 100 lbs.
Majority of workday is performed while sitting, standing, and walking.
Requires the use of hands for simple grasping and fine manipulations.
Ability to climb, bend, stoop, twist, and have full range of motion in upper and lower extremities.
Occasional exposure to dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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.
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