Pharmaceutical Development Scientist I

Pharmaceutical Development Scientist I

Position Summary:

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Pharmaceutical Development Scientist I. The Pharmaceutical Development Scientist I will serve as technical representative for formulation design and development of oral solid dosage forms. This individual will design and execute experiments and processes necessary for developing formulations of pharmaceuticals oral solid. The Scientist I will also lead clinical trial manufacturing endeavors and ensures that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).

This is a full-time salaried position on-site: Monday – Friday, 7:30am-4:30pm.

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 Role:

• Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics
• Authors technical documents, such as protocols, batch records, test methods, technical reports, and operating procedures. Review technical documents for accuracy, thoroughness and regulatory compliance
• Trains, coaches or mentors team members on technical development or business issues. May have limited responsibility to direct work of technical staff, including work assignments. Supervised customer interaction on team meetings
• Utilize knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation
• Executes efficiency improvement project with moderate guidance. Identify and recommend business opportunities on a project specific basis
• Has advanced knowledge of the principles, theories and concepts applicable to a limited range of work in pharmaceutics and knowledge of principles and concepts in other disciplines
• Applies technical and functional knowledge to assist in experiment/project design that will enable department to meet goals
• All other duties as assigned

The Candidate:

• Candidate must have either a Bachelor's degree in related scientific field with six years of related work experience, OR a Master’s of Science with four years related work experience, OR a Doctorate (PhD) in scientific field would be acceptable without any experience
• Hands on experience in oral solid dosage form development and manufacturing preferred. Must show knowledge of techniques in design of experiments and statistics, and cGMP and Good Documentation Practices in accordance with applicable regulatory guidance and Site SOPs
• Must have the ability to: learn and retain technical information, proactively address work issues at both an individual level and a team level, communicate proficiently with internal and external stakeholders
• Must have experience developing and executing minimally complex procedures or methods with high quality and becoming familiar with drug development milestones and their context. Recognizes and elevates changes in project scope or execution for review by project manager an