Pharmaceutical Development Senior Scientist I

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Pharmaceutical Development Senior Scientist I to join our team. In this role, you will lead formulation design and development of oral solid dosage forms. You will design and execute experiments, oversee clinical trial manufacturing, and ensure compliance with regulatory requirements and good manufacturing practices. You will also author and approve technical documents and play a key role in customer interactions and project outcomes.

Shift: Monday to Friday 8am-5pm
Location: Kansas City, MO
100% Onsite

The Role

• Develop and execute laboratory work plans and schedules for self and junior team members, using customer milestones and site performance standards

• Independently author and approve technical documents such as protocols, technical reports, batch records, test methods, and operating procedures

• Review technical documents for accuracy, thoroughness, and regulatory compliance

• Train, coach, and mentor others on technical, personal development, or business issues

• Supervise technical staff, including work assignments and performance management

• Serve as project technical lead on multiple projects, ensuring project outcomes and managing customer interactions

• Apply knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation, and formulation development

• Drive improvement projects at the department level and identify opportunities for improvement

• Support development of business strategies across business units

• Use comprehensive knowledge to lead complex projects within the pharmaceutics department

• Design experiments and projects that contribute to the overall direction of the department

• Perform all other duties as assigned

The Candidate

Minimum Requirements

• Bachelor's degree in a related life science or physical science field with 16+ years of related work experience preferred

• Knowledge of techniques in design of experiments

• Ability to maintain current Good Manufacturing Practices and Good Documentation Practices in accordance with regulatory guidance and site procedures

• Advanced project management skills for multiple concurrent projects of moderate complexity

• Experience in most aspects of drug development and lifecycle support, with ability to develop strategies to meet regulatory milestones

• Broad technical acumen in multiple techniques and understanding of their application in pharmaceutical services

• Ability to provide reliable interpretations of regulatory guidance for customers

• Capable of rapid learning of unfamiliar principles or techniques with minimal training

• Strong organizational skills with ability to manage multiple activities simultaneously

• Excellent written and verbal communication skills with internal and external customers

• Ability to communicate moderately complex technical information to non-technical audiences

• Leadership development and supervisory skills expected

• Ability to recommend and assist in implementation of new technologies and understand their impact on offerings

• High personal credibility with peers and subordinates

• Strong motivational skills and team development experience

• Lead by example according to company values and culture

• Ability to assess training needs and create development plans for direct reports

• Ability to anticipate and identify unmet customer needs based on technical skills and drug development experience

• Ability to interpret and manage a variety of instructions across multiple work groups

• Understanding of regulatory Chemistry, Manufacturing, and Controls (CMC) filing package and required drug product documentation

• Ability to work effectively under pressure to meet deadlines

• May publish or present externally

• Stand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 6 hours per day

• Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen

• Able to work with respirator (P100, PAPR, etc.)

• Occasional lifting and/or moving up to 50 pounds

Preferred Skills & Background

• Hands-on experience in oral solid dosage form development and manufacturing preferred

• Master’s degree in a related life science or physical science field with 14+ years of related work experience preferred

• Doctorate degree in a related life science or physical science field with 10+ years of related work experience preferred

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Competitive paid time off plus 8 paid holidays

• Community engagement and green initiatives

• Medical, dental, and vision benefits effective day one of employment

• Tuition reimbursement

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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