Pharmaceutical Development Principal Scientist I

About the role

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 The Candidate 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 Why you should join Catalent 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 acc

Benefits

Additional Information

Pharmaceutical Development Principal Scientist I Position Summary Work Schedule: Monday to Friday 8am-5pm 100% based on-site in Kansas City Catalent's Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions-from science and engineering to operations and logistics. 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.

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