Pharmaceutical Development Principal Scientist I

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 facilities; 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. The Role Develop and execute laboratory work plans/schedules for self and team, using customer milestones and Division/site performance standards and metrics Independently author and approve technical documents, such as protocols, test methods, technical 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 relationships 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/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 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 accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement GymPass program to promote overall physical wellness Catalent offers rewarding opportunities to further your career. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Personal initiative. Dynamic pace. Meaningful work. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Equal Opportunity Employer statement: Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. California Job Seekers can find our California Job Applicant Notice. #J-18808-Ljbffr Catalent Pharma Solutions