Pharmaceutical Development Principal Scientist I

Catalent; Kansas City (MO); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Defined career path

Diverse culture

Medical benefits day one

Tuition reimbursement

Job summary

Catalent in Kansas City, MO, is seeking a Pharmaceutical Development Principal Scientist I to lead oral solid development programs. You will author key documents, support clients, and drive strategic department initiatives in a 100% onsite setting.

The role requires strong project management, regulatory knowledge, and leadership abilities, with collaboration across marketing and business development to win new work.

Qualifications

• Bachelor's degree in a life or physical science with substantial related experience.
• Knowledge of oral solid dosage development and manufacturing preferred.
• Experience with design of experiments and statistics and strong technical writing.

Responsibilities

• Develop and execute lab work plans for self and team based on milestones.
• Author and approve technical documents: protocols, test methods, reports, and SOPs.
• Review documents for regulatory compliance and accuracy.
• Train, coach, and mentor staff; supervise and perform performance management.
• Direct projects, manage customer interactions, and drive department improvements.

Skills

Oral solid dosage

Regulatory understanding

Project management

Technical documentation

Mentoring

Education

Bachelor's degree in life/physical science

Doctorate preferred

Job description

About Site

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

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 Principal Scientist I to join our team. In this role, you will provide technical expertise and support for oral solid development programs. You will work closely with clients, support marketing activities, and author key technical documents. This position also involves troubleshooting, risk assessments, and contributing to strategic initiatives within the department.

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 team, using customer milestones and site performance standards
• Independently author and approve technical documents such as protocols, test methods, reports, certificates of analysis, 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 director on multiple projects, ensuring project outcomes and managing customer interactions
• Identify and drive department-level improvements independently
• Support development of business strategies for multiple customers across company sites
• Apply technical, functional, and business knowledge to design experiments and provide scientific consultation
• Contribute to the strategic direction of the department by recommending actions based on experimental results or scientific information
• Perform all other duties as assigned

The Candidate

Minimum Requirements

• Bachelor's degree in a related life science or physical science field with 24+ years of related work experience preferred; equivalent extensive related work experience may be considered in lieu of a degree
• Knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, and encapsulation
• Knowledge of techniques in design of experiments and statistics
• Ability to maintain high-quality laboratory documentation in accordance with regulatory guidance and site standard operating procedures
• Advanced project management skills for multiple concurrent projects of moderate to high complexity
• Experience in most aspects of drug development and lifecycle support, with ability to develop strategies to meet regulatory milestones
• Broad technical acumen with significant expertise in one or more techniques and understanding of their application in pharmaceutical services
• Ability to provide reliable interpretations of regulatory guidance and defend positions to regulatory agencies
• Capable of rapid learning of unfamiliar principles or techniques with minimal training
• Strong organizational skills to manage and direct multiple activities simultaneously
• Excellent written and verbal communication skills with internal and external customers
• Ability to lead challenging discussions with customers and drive resolution
• May be accountable for meeting business unit revenue targets
• Leadership development skills expected
• Proactively identifies and implements new technologies and understands their impact on offerings
• Recognized as a subject matter expert with high personal credibility
• Excellent motivator, skilled in team development
• Lead by example according to company values and culture
• Works directly with Business Development to win new business, including conference calls and customer meetings
• Ability to work effectively under pressure to meet multiple deadlines
• May publish or present externally
• Physical requirements: Stand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 8 hours per day; frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen; frequent travel required

Preferred Skills & Background

• Substantial experience in oral solid dosage form development and manufacturing preferred
• Doctorate degree in a related life science or physical science field with 18+ years of related work experience preferred, or Master’s degree with 22+ 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.

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 [e-mail]. 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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