Process Scientist I
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. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Process Scientist I will assist and support transfer and process development activities. The Process Scientist I will partner with inventory control personnel to help ensure that an adequate inventory of raw materials is maintained at all times.
The Role
Provide support in the planning and scheduling of development batches while taking into consideration demand and capacity as well as time requirements and constraints.
Under close supervision, assist development staff in activities related to the manufacture and optimization of suitable processes and GMP batches.
Assist in developing and optimizing suitable processes for commercial scaleup and support transfers of commercial products to the site.
Assist with the writing of SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed.
Collaborate and provide feedback on batch records, protocols, and other technical services documentation.
Ensure that all work is accurate, precise, properly documented and in the case of commercial product, performed within GMP guidelines.
Maintain competence and training documentation for relevant equipment and processes.
Perform any additional assigned tasks including: calibration, analysis, cleaning, facility maintenance, raw material inventory, warehouse operations, etc.
All other duties as assigned.
The Candidate
Bachelor’s degree in chemistry, engineering, or related science OR
Associate degree in chemistry, engineering, or related science with at least 2 years of relevant pharmaceutical industry experience OR
High school diploma or equivalent with at least 5 years of equivalent pharmaceutical industry experience.
Experience with oral solid dosage form manufacturing preferred.
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.
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 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.
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