Pharmaceutical Development Lead Scientist I

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 Lead Scientist I to join our team. In this role, you will serve as the technical lead for formulation design and development of oral solid dosage forms. You will design and execute experiments and processes for pharmaceutical formulations and lead clinical trial manufacturing activities. This position ensures compliance with regulatory requirements, good manufacturing practices and standard operating procedures.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 standardsAuthor and approve technical documents such as protocols, test methods, reports, certificates of analysis and operating proceduresReview technical documents for accuracy, completeness and regulatory complianceTrain, coach and mentor others on technical, personal development or business issuesSupervise technical staff, including work assignments and performance managementAct as technical lead on one or more projects, responsible for project outcomes and customer interactionDevelop and execute efficiency improvement projectsIdentify and recommend business opportunities on a project-specific basisApply technical and functional knowledge to design experiments, processes and formulations that contribute to the groupParticipate in client interactions during team and ad hoc meetings with minimal supervisionMaintain high-quality laboratory documentation in accordance with regulatory guidance and site proceduresPerform all other duties as assignedThe CandidateMinimum RequirementsBachelor's degree in a related life science or physical science field with 11+ years of related work experience preferredExpert in data interpretation, applications, instrumentation and theory in at least one area of expertiseAbility to provide accurate data within regulatory guidanceExperience evaluating and assessing impact of changes to controlled documents or project scopeAbility to combine and interpret data from multiple disciplines for a projectStrong prioritization skills and ability to suggest alternatives or contingencies for technical solutionsAbility to propose deviations from established procedures based on sound judgmentExcellent written and verbal communication skills with internal and external customersAbility to communicate technical information to non-technical audiencesAbility to learn and retain technical informationLeadership development and supervisory skills expectedAbility to assess new technologies and their impact on offeringsLead by example according to company values and cultureAbility to assess training needs and create development plans for subordinatesAbility to anticipate and identify unmet customer needs based on technical skills and drug development experienceAbility to interpret and provide instructions in various formatsUnderstanding of regulatory CMC filing package elements and required documentationWell organized with ability to multitaskAbility to work effectively under pressure to meet deadlinesMay publish or present externallyPhysical requirements: Stand, walk, sit, use hands to manipulate and reach with hands and arms for up to 8 hours per day; frequent sitting, standing, walking, reading documents and using a computer screen; able to work with respirator (P100, PAPR, etc.); occasional lifting and moving up to 50 poundsPreferred Skills & BackgroundMaster’s degree in a related life science or physical science field with 9+ years of related work experience preferredDoctorate degree in a related life science or physical science field with 5+ 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