Pharmaceutical Development Principal Scientist I

Catalent Pharma Solutions•Kansas City, MO

1d•Onsite

About The Position

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.

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
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

Nice To Haves

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

Responsibilities

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