Pharmaceutical Development Principal Scientist I

Catalent•Kansas City, MO

16h•Onsite

About The Position

The Pharmaceutical Development Principal Scientist I position is a 100% on-site role in Kansas City, supporting integrated drug development, manufacturing, and clinical supply services. This role provides sales support, including client meetings, marketing support (case studies, webinars), authoring validation protocols and reports, 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.