Pharmaceutical Development Principal Scientist I

Catalent • Kansas City, MO

2d • Onsite

About The Position

The Kansas City Pharmaceutical Development Principal Scientist provides Sales support on the road, face to face meeting with clients at their facililties; Support for marketing activities, constructing case studies, webinars, etc; Authoring of validation protocols, reports, QbD studies; Support for investigations and risk assessments; Support for IP due diligence and the “Bright Ideas” program; Trouble shooting issues encountered with Tech Transfer Activities; and 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/phsyical 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

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with quarterly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• GymPass program to promote overall physical wellness

What This Job Offers

• Job Type: Full-time
• Career Level: Senior