Pharmaceutical Development Principal Scientist I

Catalent Pharma Solutions•Kansas City, MO

2d•Onsite

About The Position

The Pharmaceutical Development Principal Scientist I position is a 100% on-site role in Kansas City, Monday to Friday, 8 am-5 pm. This role supports Catalent’s Kansas City facility, a key site for integrated drug development, manufacturing, and clinical supply services. The Principal Scientist will provide sales support, including face-to-face client meetings, and support marketing activities such as constructing case studies and webinars. Responsibilities also include authoring validation protocols and reports, conducting QbD studies, supporting investigations and risk assessments, assisting with IP due diligence and the “Bright Ideas” program, troubleshooting technical transfer issues, and serving as a technical formulation development/manufacturing SME for oral solid development programs.

Requirements

Bachelor’s degree in life/physical science with 13+ years related experience or Master’s degree in Life Science and 11+ years experience, or Doctorate in life/physical sciences with 10+ years experience or an equivalent education, experience and training required.
Substantial experience in oral solid dosage form development and manufacturing preferred
Knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation
Knowledge of techniques in design of experiments and statistics
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity
Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones
Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings
Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies
Capable of rapid learning of multiple unfamiliar principles or techniques with minimum training
Ability to interpret and evaluate a variety of instructions furnished in written, oral, diagram, or schedule form
Well organized with ability to handle and direct multiple activities simultaneously
Excellent written and verbal communications skills with internal and external customers
Able to lead difficult discussions with customers and drive the conversation to an acceptable resolution
Proactively identifies and implements new technologies and understands their impact on Catalent offerings
Recognized by internal and external customers as a subject matter expert with high personal credibility

Responsibilities

Develop and execute laboratory work plans/schedules for self and team, using customer milestones and Division/site performance standards and metrics
Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures
Review technical documents for accuracy, thoroughness and regulatory compliance
Trains, coaches or mentors others on technical, personal development or business issues
Supervises technical staff, including work assignments and performance and development management
Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business
Identifies and independently drives department level improvements
Support development of business strategies for multiple customers across multiple company sites
Applies technical, functional, business and/or industry knowledge to design experiments/projects; provide scientific consultation to the department
Actively contributes to the strategic direction of the department by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information
All other duties as assigned