The laboratory groups at Catalent RTP are responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other Catalent facilities. This includes formulation development, structural chemistry, analytical support, and clinical trials material manufacturing.
II. Department Summary:
As a member of the inhalation development team, you will utilize your expertise to support the advancement of a variety of pulmonary dosage forms that include pMDIs, DPIs, nasal sprays and solutions/suspensions for inhalation. Your efforts will focus on delivering high-quality scientific contributions by supporting development workflows relevant to the various phases of the product life-cycle. As a scientist and leader in our organization, you will be a key component of the engine that powers our operation, applying expertise in physical chemistry, analytical chemistry, formulation development, and/or process development.
Experience with inhaled product testing and development is desirable. This includes but is not limited to impaction analyses (ACI and NGI), morphological assessments, particle-size characterization, spray-pattern analyses, plume geometry measurements, separation sciences (HPLC, uPLC, and GC), and automated actuation and sample collection platforms.
III. Job Summary
Usually works with some supervision, conferring with superior on unusual matters. May be assisted by laboratory technicians/assistants or associate level scientists. Assignments are broad in nature, requiring originality and ingenuity. Has appreciable latitude for un-reviewed action or decision. He/she may direct projects and employees, taking on a technical lead role. Comply with divisional and site Environmental Health and Safety requirements.
IV. Specific Duties, Activities, and Responsibilities:
• Develop and execute laboratory work plans/schedules independently,using customer milestones and Division/site performance standards and metrics
• Authors 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
• Responsible as Project Director with responsibility for project outcome and customer interaction
• Executes efficiency improvement project with guidance
• Identify and recommend business opportunities on a project specific basis
V. Job Qualifications
Education and Experience:
• Doctoral degree, Master's degree, Bachelor's degree, or Associate's degree in chemistry or closely related physical science from a four-year college/university or equivalent education and training
• PhD and 0-2 years related experience, MS and 4-6 years related experience, BS and 7-9 years related experience, or equivalent education, experience and training
Knowledge, Skills and Abilities:
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Ability to learn and retain technical information
• Proactively address work issues at both an individual level and a team level
• Develop and execute complex procedures or methods with high quality
• Becoming familiar with drug development milestones and their context
• Recognizes and elevates changes in project scope or execution for review by project director
• Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
• Propose deviations from established procedures and methods based upon sound judgment.
• Excellent written and verbal communications skills with internal and external customers
• Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance.
• Lead by example according to Catalent's values and culture
• Can assess training needs and formulate development plans for subordinates
• Recognize unmet customer needs
• Can effectively back-up supervisor to address limited technical or business issues with prior instructions
• Strategy is focused on personal and team time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines...cont.
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