Principal Process Scientist

Catalent

7d • Onsite

About The Position

Principal Process Scientist
Position Summary
100% on-site in Greenville, NC
Work Schedule: Monday to Friday, normal business hours
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. As a technical manager, this role is responsible for leading the development of improved product transfer processes and ensuring commercialization of products is effective. Post-launch this position is responsible for leading process improvements, resolving technical issues and leading root cause investigations involving product nonconformance.

Requirements

• 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 required
• 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
• This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.

Responsibilities

• 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
• Write campaign summary reports
• Minimize potential for issues or impact of issues during the manufacturing process transfer and post-launch support
• Collaborate with Validation group to transfer knowledge and ensure a successful validation campaign
• Other duties assigned

Benefits

• Competitive medical benefits and 401K
• 152 hours 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees