Pharmaceutical Development Senior Scientist I
Catalent
About SiteCatalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.Position SummaryWe have an opportunity for a Pharmaceutical Development Senior Scientist I to join our team. In this role, you will lead formulation design and development of oral solid dosage forms. You will design and execute experiments, oversee clinical trial manufacturing, and ensure compliance with regulatory requirements and good manufacturing practices. You will also author and approve technical documents and play a key role in customer interactions and project outcomes.Shift: Monday to Friday 8am-5pmLocation: Kansas City, MO100% OnsiteThe RoleDevelop and execute laboratory work plans and schedules for self and junior team members, using customer milestones and site performance standardsIndependently author and approve technical documents such as protocols, technical reports, batch records, test methods, and operating proceduresReview technical documents for accuracy, thoroughness, and regulatory complianceTrain, coach, and mentor others on technical, personal development, or business issuesSupervise technical staff, including work assignments and performance managementServe as project technical lead on multiple projects, ensuring project outcomes and managing customer interactionsApply knowledge of high-shear granulation, fluid-bed technology, roller compaction, compression, encapsulation, and formulation developmentDrive improvement projects at the department level and identify opportunities for improvementSupport development of business strategies across business unitsUse comprehensive knowledge to lead complex projects within the pharmaceutics departmentDesign experiments and projects that contribute to the overall direction of the departmentPerform all other duties as assignedThe CandidateMinimum RequirementsBachelor's degree in a related life science or physical science field with 16+ years of related work experience preferredKnowledge of techniques in design of experimentsAbility to maintain current Good Manufacturing Practices and Good Documentation Practices in accordance with regulatory guidance and site proceduresAdvanced project management skills for multiple concurrent projects of moderate complexityExperience in most aspects of drug development and lifecycle support, with ability to develop strategies to meet regulatory milestonesBroad technical acumen in multiple techniques and understanding of their application in pharmaceutical servicesAbility to provide reliable interpretations of regulatory guidance for customersCapable of rapid learning of unfamiliar principles or techniques with minimal trainingStrong organizational skills with ability to manage multiple activities simultaneouslyExcellent written and verbal communication skills with internal and external customersAbility to communicate moderately complex technical information to non-technical audiencesLeadership development and supervisory skills expectedAbility to recommend and assist in implementation of new technologies and understand their impact on offeringsHigh personal credibility with peers and subordinatesStrong motivational skills and team development experienceLead by example according to company values and cultureAbility to assess training needs and create development plans for direct reportsAbility to anticipate and identify unmet customer needs based on technical skills and drug development experienceAbility to interpret and manage a variety of instructions across multiple work groupsUnderstanding of regulatory Chemistry, Manufacturing, and Controls (CMC) filing package and required drug product documentationAbility to work effectively under pressure to meet deadlinesMay publish or present externallyStand, walk, sit, use hands to manipulate, and reach with hands and arms for up to 6 hours per dayFrequent sitting, standing, walking, reading of written documents, and use of computer monitor screenAble to work with respirator (P100, PAPR, etc.)Occasional lifting and/or moving up to 50 poundsPreferred Skills & BackgroundHands-on experience in oral solid dosage form development and manufacturing preferredMaster’s degree in a related life science or physical science field with 14+ years of related work experience preferredDoctorate degree in a related life science or physical science field with 10+ years of related work experience preferredWhy You Should Join CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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.Visit Catalent Careers to explore career opportunities.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 U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.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 & 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.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Kansas City, MOType: Full time
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