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Catalent Pharma Solutions jobs in Kansas City, MO - 37 jobs

  • Proposal Lead, Clinical Supply & Specialty Services

    Catalent Pharma Solutions, Inc. 4.4company rating

    Catalent Pharma Solutions, Inc. job in Kansas City, MO

    Catalent Pharma Solutions is hiring a Proposal Lead. The Proposal Lead is responsible for project management of the proposal process, including leadership of cross-functional teams to scope opportunities and gain key stakeholder review and approval, as appropriate. The role also includes the pricing, margin analysis and generation of proposals, to deliver quality and on-time Quotations to Clients. This is a permanent, full-time position. It is a salary role. The shift is Monday-Friday 8a-5p. This position is intended to be on site four days per week. This role will be based in either the Philadelphia, PA or Kansas City, MO site. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Role: * Follows the proposal process and liaises with Project Management, BD, Clients, and Management/Key Stakeholders on the generation of, and pricing for, Quotations/QARs. * Facilitates communication between functional areas of the organization (ie. BD, Project Management, Operations, Quality, Finance, etc) to ensure on-time delivery of Quotations / proposals that are accurate and executable in terms of technical scope and meet costing / business margin targets. * Works with all Operations functions to determine the most optimal and cost effective development/manufacturing/packaging methods and to request pricing on any additional items to support quotation generation, as needed. * Communicates directly with client contacts and leads and/or participates in client meetings, as needed to support the Proposal / BD process. * Works collaboratively and professionally in accordance with the global processes and to support global objectives. * Works with BD, Operations, and Finance to produce optimal value pricing solutions, as appropriate for proposals managed. * Other duties as assigned. The Candidate: * Life Sciences Bachelor's degree (or equivalent) or business degree, or equivalent work experience preferred. * Min. 3 years+ industry experience. * Clinical experience required. * Project management experience is preferable. * Understanding of the contract development / research, pharmaceutical and biotech industries. * Knowledge and experience in cGMP and FDA regulated working environments is desirable. Why you should join Catalent: * Defined career path and annual performance review and feedback process * Diverse, inclusive culture * 19 days of PTO + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $44k-77k yearly est. Auto-Apply 5d ago
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  • Pharmaceutical Packaging Technician II

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Work Schedule: Monday - Friday 2:30PM - 11:00PM 100% onsite 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 Pharmaceutical Packaging Technician II is responsible for running various types of production equipment in primary and/or secondary packaging. The Role: Inspect drug products, components, and labels for accuracy and quality Follow safety, quality, and compliance standards during packaging operations Execute batch records for clinical and commercial packaging Report any issues or deviations promptly Maintain accurate documentation in line with SOPs and cGMP All other duties as assigned The Candidate: High School or General Education Diploma required Clinical trial packaging or related Manufacturing/Operations experience preferred Ability to interpret a variety of instructions in written, oral, diagram, or schedule form Basic computer skills - including, but not limited to e-mail, Microsoft Word, Internet Explorer; Basic math skills Individual may be required to sit, stand, walk regularly and occasionally lift to 50 pounds Why you should join Catalent: Career growth with a clear path and regular performance reviews Day-one benefits: medical, dental, vision 401(k) match, tuition reimbursement, and wellness perks Paid time off: 152 hours + 8 holidays Inclusive culture with Employee Resource Groups and community initiatives Discounts from 900+ merchants via Perkspot A mission-driven workplace where your work helps save lives 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $33k-42k yearly est. Auto-Apply 6d ago
  • Manager, Human Resources

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This is a full-time salaried position located onsite at our Kansas City, MO facility. The Kansas City Manager, Human Resources position is responsible for assisting in the development, implementation and administration of local and global policies and programs for staffing, employee relations, compensation and benefits, employee development and training, organizational development, regulatory compliance to meet the business strategies and customer requirements of the Kansas City, MO facility within the framework of Catalent's overall corporate philosophy and policies, external laws and regulations. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Develops and directs the establishment and maintenance of policies, procedures, plans and programs dealing with the specific activities of staffing, employee relations, compensation and benefits, employee development and training, organizational development, HR information systems to meet the site's business plan and competitive strategy in a cost effective manner Ensures alignment of such policies, procedures, plans, programs and budgets with those of Catalent Pharma Solutions Partners with Business Unit Site-based leadership in the organization's strategic planning efforts, providing insight on vital HR concerns and ensuring alignment with overall business objectives Provides counsel to managers and employees on human resources issues, organization structure and development Establishes and maintains an effective and credible relationship with both management and employees; works closely with line management to provide support, planning and problem solving Partners with global recruiting team on the organization's recruitment, selection and placement of talent with the critical technical and management skills required to ensure the continuity of operations, and leadership bench strength development Develops, implements and administers an effective performance management system aimed at improving employee and organizational productivity Other duties as assigned The Candidate: Bachelor's Degree in relevant discipline (e.g., Human Resources, Business Management or equivalent), required; Master's Degree, preferred or PHR/SPHR certification, preferred Minimum seven years broad and progressive experience in human resources, required Experience in supervisory or management role, preferred Exposure to the pharmaceutical, healthcare or related technical industries, preferred Experience supporting a manufacturing environment (24x7 scheduling variations), preferred Advanced PC skills, including Excel with the ability to run analytics on HR data, and knowledge of company specific software packages Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds 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 Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement WellHub - program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $59k-79k yearly est. Auto-Apply 17d ago
  • Director of Pricing - Clinical & Specialty Services, US

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    **Director of Pricing, US** + 100% on-site Catalent is a global leader in clinical supply services, working with clinical trial sponsors of all sizes to reliably supply their clinical trials. With 9 GMP facilities in the US, EU, and Asia/Pacific region, and more than 50 depots covering 6 continents, our **Clinical & Specialty Services** (CSS) segment delivers flexible, integrated solutions to accelerate product development and ensure reliable global supply chain execution. The Director of Pricing will lead the development, execution, and continuous improvement of pricing strategies and commercial proposal processes across clinical services. This role is pivotal in driving sales and revenue growth, ensuring pricing consistency, and enabling scalable commercial execution in a fast-paced CDMO environment. It will also support strategic initiatives such as cost/margin model updates and analysis, competitive pricing database development, and quoting system upgrades. **The Role** + Develop and manage global pricing strategies across all areas of clinical supply services. + Build and maintain cost models, pricing tools, and margin targets aligned with business goals. + Lead pricing reviews and approvals for complex or high-value proposals. + Advise on winning pricing strategies based on customer type, region, and opportunity scope. + Support the implementation of scalable systems to improve proposal accuracy and efficiency. + Monitor pricing trends and win/loss rates. + Conduct regular reviews comparing quoted estimates to actual costs to validate that cost model assumptions remain aligned with operational performance. + Partner with Finance, Operations and site leadership teams to align pricing with cost structures and margin targets. + Support Business Development team with tools and guidance to improve win rate. + Other duties as assigned. **The Candidate** + Bachelor's degree preferred. + Experience in the pharmaceutical or CDMO industry, with a strong background in pricing, commercial operations, or financial analysis. + Experience in clinical development services pricing is highly preferred. + Proven ability to develop activity-based cost and pricing models and lead commercial process improvements. + Strong business acumen, strategic thinking, and analytical capabilities. + Proficiency in Salesforce, Excel, and other proposal systems. + Excellent communication skills. + Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. **Pay** The anticipated salary range for this position in NJ is 180,000-225,000 plus bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why You Should Join Catalent** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + Dynamic, fast-paced work environment. + 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 **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $125k-230k yearly est. 29d ago
  • Pharmaceutical Development Technician I

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Work Schedule: Monday - Friday, 2:00PM - 10:30PM 100% onsite 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 Pharmaceutical Development Technician I is responsible for performing setup/teardown, manufacturing and cleaning of all equipment and processes associated with manufacturing operations. The Role Ensures that all Catalent safety procedures are followed and identifies/communicates the necessary adjustments to address potential safety concerns. Will also ensure the proper use of PPE (Personal Protection Equipment) Focuses on learning all equipment and testing within core group while maintaining high quality standards Maintain up to date training on equipment and site procedures Perform daily tasks to ensure that working areas are stocked with proper materials and supplies Perform physical characterization testing on raw and in-process materials Support sampling and packaging of in-process and finish product material Maintain active inventory of excipients and API used for Experimental processing Other duties, as assigned The Candidate High School degree or equivalent Must be able to manage priorities and projects effectively Must communicate clearly with all levels of management Capability to work in a matrix organization Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk, hear, and smell, and lift to 40 pounds. Specific vision requirements include reading of written documents; visual inspection of materials and frequent use of computer monitor screens Why you should join Catalent Career growth with a clear path and regular performance reviews Day-one benefits: medical, dental, vision 401(k) match, tuition reimbursement, and wellness perks Paid time off: 152 hours + 8 holidays Inclusive culture with Employee Resource Groups and community initiatives Discounts from 900+ merchants via Perkspot A mission-driven workplace where your work helps save lives 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $72k-113k yearly est. Auto-Apply 19h ago
  • Senior Validation Specialist I, BioAnalytics CSV & Compliance

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance. The Senior Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI), projects and all associated expectations and activities at the BioAnalytics site. This person is also responsible for drafting, reviewing, and approving technical documents such as Standard Operating Procedures (SOPs), validation protocols, risk assessments, Change Controls and Deviations in a Good Manufacturing Practices (GMP) environment. **This is a full-time on-site salaried position: Monday - Friday on 1st shift.** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role:** + Will lead all aspects of CSV program including ownership of project Objectives, Timelines, Resources, Cost and Quality from small to large site-level technology program rollouts for the site + Work with external technology vendors, internal support groups (local IT, global-corporate IT, Validation, QA) and internal Business Units (Manufacturing, Pharmaceutics, Analytics, Quality Control) to successfully manage all assigned CSV program deliverables + Successful application of solid Project Management skills in procurement, integration, and implementation of new and upgrades of laboratory software, instruments, applications, and information systems + Author, review and approve CSV, DI and Validation related documents and provide input and guidance to Site Leadership as KCM's CSV & DI Subject Matter Expert (SME). Ensure all CSV deliverables driven by System, Software, User Functionality and Safety Requirements are developed, executed, and documented per KCM SOPs, Corporate Policies and Regulatory guidelines + Represent KCM BioAnalytics as the CSV and DI SME in Regulatory, Client and Internal Catalent audits. Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance. Mentor junior colleagues in good documentation practices (GDP) + Research and write general Periodic Reviews/Data Integrity Reviews for all qualified items including equipment, instruments, and software systems, as applicable. Perform support compliance activities such as risk assessments, data integrity effects, etc. + Author deviations as a lead investigator for the analytical department and drive them to completion. Support Validation Management in ensure all CSV activities meet Scope, Schedule, Budget, and Quality requirements; including participation in budget reviews and other financial programs, as directed + Participate, support, and drive Continuous Improvement initiatives. Assist in Change Management, CAPA, and Deviations. Perform and co-ordinate peer review of validation protocols, and risk assessments + All other duties as assigned **The Candidate:** + Requires a Bachelor's Degree minimum in a Scientific field with at least six years of relevant experience. We will also accept a Master's Degree with four years of experience OR a PhD with at least three years of relevant experience + Must demonstrate knowledge of CSV, Validation, Quality, IT and Regulatory Compliance. Familiarity with cGMPs, ISPE GAMP5, fundamental validation practices and the following FDA and European Commission Regulations (such as: 21CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, 21CFR820, Quality System Regulation, 21CFR11 - Electronic Records, Electronic Signatures, EudraLex, Volume 4, Good Manufacturing Practices, Annex 11 Computerized Systems) + Solid understanding and application towards regulatory compliance, vendor/client/regulatory audits, SxP development, Change Management, CAPA, Deviations, and Quality System Regulation disciplines + Based on broad technical skills and drug development experience, anticipates, and identifies unmet customer needs. Able to evaluate and assess impact of proposed changes to GMP documents and/or project scope + Ability to work effectively under pressure to meet deadlines and exhibit critical thinking and offer solutions. Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization + Well organized with ability to multitask and execute multiple tasks within a given timeframe efficiently. Coaching skills are expected to train junior scientists + **Physical requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $61k-79k yearly est. 60d+ ago
  • Packaging Coordinator

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    **Production Coordinator** + **Work Schedule:** Monday - Friday, 2:30PM - 11:00PM + **100% onsite** 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 **Production Coordinator** is responsible for reviewing batch records within production packaging. **The Role:** + Ensure packaging job readiness by coordinating with storage facility, label control, and quality assurance personnel for packaging material and component requests + Preparation of packaging batch record documentation in compliance with SOPs and cGMP + Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs + Performing adjustments in inventory system to accurately reflect packaging job activities + Ensure that any corrections to the packaging batch record are completed accurately + Ensuring a high-quality standard of work by reporting any deviations to packaging instructions or procedures to management + All other duties as assigned **The Candidate:** + High School diploma or equivalent required + Bachelor's degree is preferred + Prior experience in manufacturing batch record review highly preferred + Minimum of 3 years of clinical trial packaging, or related pharmaceutical operations experience, preferred + Intermediate computer skills include, but not limited to Microsoft Outlook, Microsoft Word, Microsoft Excel, Inventory Systems, SharePoint, Citrix, etc. **Why you should join Catalent:** + **Career growth** with a clear path and regular performance reviews + **Day-one benefits:** medical, dental, vision + **401(k) match** , tuition reimbursement, and wellness perks + **Paid time off:** 152 hours + 8 holidays + **Inclusive culture** with Employee Resource Groups and community initiatives + **Discounts** from 900+ merchants via Perkspot + **A mission-driven workplace** where your work helps save lives **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $28k-40k yearly est. 60d+ ago
  • Quality Control Senior Associate Scientist I

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Work Schedule: Monday - Friday 12:00PM - 8:00PM 100% onsite 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 Quality Control Senior Associate Scientist I is responsible for performing raw material testing, to support clinical manufacturing. The Role: Executes various laboratory test methods for raw material release testing Maintains accurate and high-quality laboratory documentation in accordance with regulatory guidance and site SOPs Performs parallel review of laboratory documentation Assists in execution of efficiency improvement projects Other duties as assigned The Candidate: Bachelor's degree in chemistry or closely related physical science required Minimum 2 years of relatable experience highly preferred Prior knowledge of current Good Manufacturing Practices (cGMP's) and Standard Operating Procedures (SOPs) preferred Why you should join Catalent: Career growth with a clear path and regular performance reviews Day-one benefits: medical, dental, vision 401(k) match, tuition reimbursement, and wellness perks Paid time off: 152 hours + 8 holidays Inclusive culture with Employee Resource Groups and community initiatives Discounts from 900+ merchants via Perkspot A mission-driven workplace where your work helps save lives 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $61k-77k yearly est. Auto-Apply 60d+ ago
  • Supervisor, Production

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Work Schedule: Monday - Friday, 6:30AM - 3:00PM 100% onsite 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 Supervisor, Production manages the day-to-day activities and employees within the Packaging Group. The Role: Responsible for process improvements Responsible for procedures and written content of those procedures in the SOPs Responsible for presenting and defending policies and procedures to both internal and external management and auditors Responsible for the management and development of direct reports In the event of a processing deviation or non-conformance, must be able to effectively sort through data and interview involved associates to determine both the nature of the event, plan the most appropriate corrective action, and to develop a plan to keep similar instances from occurring in the future All other duties as assigned The Candidate: A High School diploma or GED is required Bachelor's degree is preferred Minimum 5 years of relevant experience in production operation is required Prior cGMP experience highly preferred Why you should join Catalent: Career growth with a clear path and regular performance reviews Day-one benefits: medical, dental, vision 401(k) match, tuition reimbursement, and wellness perks Paid time off: 152 hours + 8 holidays Inclusive culture with Employee Resource Groups and community initiatives Discounts from 900+ merchants via Perkspot A mission-driven workplace where your work helps save lives 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $50k-70k yearly est. Auto-Apply 50d ago
  • Manager, Drug Enforcement Administration

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This is a full-time salaried position, based out of our Kansas City, MO site. The Manager, Drug Enforcement Administration will oversee the state of DEA regulatory compliance of controlled substances at the Kansas City, MO site through the following: oversee the inventory and other aspects regarding the use and storage of controlled substances in pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments. The Manager, Drug Enforcement Administration will support all necessary regulations with DEA 21 CFR 1300 to end, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting and maintaining NABP Drug Distributor Accreditation. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction. The Kansas City facility is also a Center-of-Excellence for our Biologics Analytical Services business. Our large molecule analytical team has over 25 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects. We provide support for drug substance, drug product, and intermediates for both innovator and biosimilar/biobetter products. Our facility also offers comprehensive clinical packaging services including clinical supply management, package engineering, clinical manufacturing, primary and secondary packaging, global distribution and logistics, and return/destruction services. The facility features an isolated potent suite and DEA Schedule I-V controlled drug storage to handle even your most challenging products. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible to ensure order, receipt and process distributions are observed and recorded per site procedures to assure the inventory records of Controlled Substances are accurate and completed to meet DEA regulations Provide training for Authorized Associates approved to work with Controlled Substances and oversight of daily activities Assure new hires are appropriately screened and existing DEA Authorized Associates are rescreened, as required by site procedures while maintaining an accurate list of Authorized Associates at all times Support Audit Ready 365 initiatives including management of DEA inspections through ownership of DEA binder, tracking of observation findings and action completions in Trackwise, and other duties as required Provide support as DEA Subject Matter Expert, as required Responsible for the controlled substance programs at KCM to include holding Power of Attorney for DEA Registrations. Complete accurately, file, and submit (as required) DEA 222 forms, DEA imports and exports, completion of DEA renewal applications, File DEA 106s (theft and loss form), ARCOS, YERS, and required end of year reports Participate in all inventory variances, deviations, and/or investigations involving controlled substances Provide support of state licensure, including Drug Distributor Accreditation, through the review of applications; Ensure license expiration dates are monitored and renewal applications completed on time to assure KCM operates a GMP facility in compliance with Applicable Laws, including the requirements for state reporting of controlled substances Other duties as assigned The Candidate: Bachelor's Degree, required Minimum of five years of DEA Compliance experience, required Demonstrated people management over at least 3 direct reports, required Scientific and Quality Assurance experience, preferred Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience 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 Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement WellHub - program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $49k-70k yearly est. Auto-Apply 17d ago
  • Distribution Associate II

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    **Distribution Associate II (2nd shift)** + **Work Schedule:** Sunday - Thursday12pm-8:30pm + 100% on-site _Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects._ The Kansas City **Supply Chain Distribution Associate II** supports clinical trial projects through accurately picking and packing clinical site and depot shipments; providing warehouse support to the Packaging, Manufacturing, Logistics and Quality Assurance groups, and ensuring that all work carried out is following regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Although the focus is Distribution, this position will also support other areas of operation as needed and as requested in order to support the needs of the business _._ **The Role:** + Follow safety and handling guidelines to protect drug, materials and others + Pick and verify orders for processing + Final verification of processed orders + Verify and Label orders at pack out + Complete order processing, including- Fed-Ex Management, Verification of materials, Kool Chain pack-out, Temperature monitor usage, and Label verification + Safe operation of forklifts, order pickers and related equipment, per OSHA guidelines + Restock distribution supplies (boxes and coolers, gel bricks, phase changes, & maintain and clean workstation) + Ability to work well with people of diverse cultures + Other duties as assigned **The Candidate:** + High School Diploma or equivalent + 1-2 years of experience in warehouse operations **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $27k-32k yearly est. 14d ago
  • Quality Control Technician I

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Work Schedule: Monday - Friday 6:30AM - 3:00PM 100% onsite 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 Quality Control Technician I is responsible for performing sampling for raw materials, to support clinical manufacturing. The Role: Perform sampling activities for raw materials Inspect consumables for conformance to specifications Perform AQL assessments of finished products Perform inventory verification as required Other duties as assigned The Candidate: High school diploma or equivalent required Prior experience with quality sampling, in a cGMP environment, highly preferred Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture 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 152 Hours + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Company match on donations to organizations Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $31k-40k yearly est. Auto-Apply 60d+ ago
  • Senior Associate Scientist I

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    **Senior Associate Scientist I (Dissolution)** + **Work Schedule:** Monday - Friday, 8AM - 4:30PM + 100% onsite (Kansas City) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Catalent's Kansas City (KCM) facility provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction. The Senior Associate Scientist I will support the Analytics and Dissolution team for in-process, release, and stability sampling and use a variety of analytical instruments. With cutting-edge technologies and a collaborative work environment, this role offers opportunities for long-term advancement. **The Role:** + Execute laboratory work plans/schedules developed with input from a supervisor or senior team member. Sample types include in-process, release or stability. Techniques include HPLC, UV/Vis, Disintegration and Dissolution. Apparatus 1, 2, 3, 5, and 6. Under direction, may perform method development, validation, and transfer activities + Maintain accurate and high-quality laboratory documentation in accordance with regulatory guidance and Site SOPs + May draft technical documents such as methods or certificate of analysis + Performs parallel review of laboratory documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance + Assists in execution of efficiency improvement projects with guidance + Trains others on laboratory techniques + All other duties as assigned **The Candidate:** + Bachelor's degree in life science or physical science is required with at least two (2) years of related work experience OR a Master's degree is required without any formal industry experience + Knowledge and skills requirements include the ability to process, maintain, and interpret data, understand basic instrument troubleshooting techniques, and communicate clearly and professionally with clients and internal stakeholders + **Physical requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $47k-72k yearly est. 30d ago
  • Finance Director

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    Director, Finance** Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products. Catalent is also the largest contract packager of pharmaceuticals. The Finance Director leads all finance and accounting activities for the Kansas City site for the PCH and the Clinical Supply business stream. The Finance Director also serves on the two site leadership team to provide financial analysis and forecasting. The position frequently communicates with Segment Leadership and Site Leadership regarding site operational and financial matters. Additional responsibilities include development of financial plans and policies, accounting practices and procedures, and the organization's relationship with stakeholders, both internal and external. The individual will provide leadership to the Finance function with overall responsibility for management and development of the department **The Role** + Directs and manages the accounting function, develops and maintains policies, procedures and budgetary controls + Provide financial decision support to the site + Manage the performance and professional development of the Finance team + Lead finance team members supporting: + Client billing and cash collections + Finance reporting for Kansas City CSS and PCH + Acquisition, protection, and disposal of company assets + Prepare Management Presentation material and present for monthly forecast/close meetings & OpMech meetings and QBRs + Monthly accounting, forecast & reporting processes to ensure that Corporate, Business Unit and Site timelines and objectives are met + Perform/Review monthly variance review of P&L results for P&Ls + Proactively identify, analyze and present financial reporting and analysis in and accurate and timely manner to Site and Functional leaders + Contribute to weekly Revenue Forecast process with Business Units + Recommends and implements techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices + Lead annual Site and Functional Budget process including development/analysis of budget tracks, developing, communicating and driving the budget timeline, creating budget templates, creating/maintaining budget roll-up files, preparing budget deliverables for Site Management and BU Leadership Team + Revenue Recognition expertise is required. Understanding multiple element arrangements revenue guidance is necessary. Documenting the policy and instructing the site and maintain appropriate controls on this process is essential + Manage internal/external audit support + Maintain the effectiveness of the financial controls for corporate governance and SOX compliance. This position is expected to learn about and gain a deep understanding of Catalent accounting policies as well as site policies and processes to ensure the financial statements are accurately reflected. Finding efficiencies in our processes and continuous improvement expected. Site readiness for successful internal and external audits is required. + Complete analysis of proposed investments and other projects + Development and implementation of policies and procedures + Represent finance function on various project teams + Represent finance function on site leadership teams **The Candidate** + Bachelor's degree in Accounting, Finance, Business Administration or a directly related field. + Minimum 10 years of progressive Finance experience, including five years of finance leadership experience with a medium to large organization. Experience working in a manufacturing environment is required, preferably for a pharmaceutical manufacturer. + Experience with Lean implementation also desired. Professional designations (CPA, CMA) or additional education (MBA) are strongly preferred. + Expert knowledge in GAAP concepts with a strong consultative but results oriented approach. + Ability to work effectively under extreme pressure to meet deadlines. + Excellent written and verbal communications skills. Ability to easily learn and retain technical information. + Experience with ERP systems required and knowledge of SAP and OneStream an advantage. Advanced PC skills and strong ability to analyze/develop capital purchases + Ability to effectively present information and respond to questions from internal and external customers and suppliers + Must have strong consultation and collaboration skills. Adept at preparing/presenting monthly & quarterly reporting packages + Ability to solve complex practical problems. Mentally strong to challenge assumptions and handle complex financial analysis + Ability to work effectively under pressure to meet deadlines + Understanding and application of payback and cash flow analysis. Understanding of the financial audit process **Why You Should Join Catalent** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + Dynamic, fast-paced work environment. + 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 **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $94k-126k yearly est. 60d+ ago
  • Supervisor, Supply Chain

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    + **Work Schedule:** Sunday- Thursday 12pm-8:30pm + 100% on-site _Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects._ **_Catalent Pharma Solutions in Kansas City, MO is hiring a_** _Supply Chain Supervisor_ **_._** _The Supply Chain Supervisor supervises the flow of goods, resources, and information required by the supply chain to ensure that critical processes run effectively and achieve organizational goals and performance KPIs._ **The Role:** + Oversees the daily workflow and schedules of the departments. + Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks in the JDE business control system. + Meet and improve performance metrics for measurement, comparison, or evaluation of factors affecting the supply chain + Develops process improvements to increase efficiency throughout the supply chain while ensuring quality and safety; implements subsequent changes to processes. + Coordinate and schedule daily cycle counts, inventory audits and investigations to ensure accurate inventory levels in onsite and offsite storage facilities. + Coordinate and perform periodic functional audits and report/maintain findings. + Collaborates with other departments and stakeholders to identify and maintain resources needed to establish and provide an effective supply chain. + Supervise daily activities to meet on time delivery to internal and external clients. + Lead and support daily stand-up meetings to review and improve People, Safety, Quality, Delivery and Cost of assigned department. + Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks. + Responsible for the overall training compliance for operation, including GMP, HR, and Safety training(Compliance Wire). + Assistance with investigations (Discrepancies, Deviations and Complaints) as well as CAPA identification and closure. + Responsible for participation in Continuous Improvement activities. + Performs other related duties as assigned. **The Candidate:** + High School diploma or GED is required. Degrees beyond high school are preferred. + A minimum of 1 year experience supervising in a manufacturing or operations environment is required. + Three years' experience supply chain operations in a pharmaceutical or regulated environment is preferred **Why you should join Catalent:** + ·Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $72k-95k yearly est. 15d ago
  • Supervisor, Supply Chain

    Catalent Pharma Solutions, Inc. 4.4company rating

    Catalent Pharma Solutions, Inc. job in Kansas City, MO

    * Work Schedule: Sunday- Thursday 12pm-8:30pm * 100% on-site Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring a Supply Chain Supervisor. The Supply Chain Supervisor supervises the flow of goods, resources, and information required by the supply chain to ensure that critical processes run effectively and achieve organizational goals and performance KPIs. The Role: * Oversees the daily workflow and schedules of the departments. * Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks in the JDE business control system. * Meet and improve performance metrics for measurement, comparison, or evaluation of factors affecting the supply chain * Develops process improvements to increase efficiency throughout the supply chain while ensuring quality and safety; implements subsequent changes to processes. * Coordinate and schedule daily cycle counts, inventory audits and investigations to ensure accurate inventory levels in onsite and offsite storage facilities. * Coordinate and perform periodic functional audits and report/maintain findings. * Collaborates with other departments and stakeholders to identify and maintain resources needed to establish and provide an effective supply chain. * Supervise daily activities to meet on time delivery to internal and external clients. * Lead and support daily stand-up meetings to review and improve People, Safety, Quality, Delivery and Cost of assigned department. * Clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks. * Responsible for the overall training compliance for operation, including GMP, HR, and Safety training (Compliance Wire). * Assistance with investigations (Discrepancies, Deviations and Complaints) as well as CAPA identification and closure. * Responsible for participation in Continuous Improvement activities. * Performs other related duties as assigned. The Candidate: * High School diploma or GED is required. Degrees beyond high school are preferred. * A minimum of 1 year experience supervising in a manufacturing or operations environment is required. * Three years' experience supply chain operations in a pharmaceutical or regulated environment is preferred Why you should join Catalent: * ·Defined career path and annual performance review and feedback process * Diverse, inclusive culture * 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 * 152 hours of PTO + 8 paid holidays * Several Employee Resource Groups focusing on D&I * Dynamic, fast-paced work environment * Community engagement and green initiatives * Generous 401K match * Medical, dental and vision benefits effective day one of employment * Tuition Reimbursement - Let us help you finish your degree or start a new degree! * WellHub- program to promote overall physical wellness * Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $53k-88k yearly est. Auto-Apply 15d ago
  • Manufacturing Product Lead

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    + **Work Schedule:** Monday - Friday 6:00AM - 2:30PM + **100% onsite** 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 **Manufacturing Product Lead** is responsible for providing technical support for oral solid dose (OSD) production processes. This includes process improvements, technology transfer, process investigations, and process troubleshooting. **The Role:** + Works cross-functionally with commercial manufacturing by providing oversight, process improvements, and operational direction. + Serves as a liaison between the site and the client, as well as the project management team, to provide production updates and answer questions. + Trains production technician team on batch records and serves as a Subject Matter Expert on day-to-day issues and troubleshooting. + Responsible for batch records, deviations, and change control. + All other duties as assigned. **The Candidate:** + Bachelor's degree required. + Bachelor's degree in chemical engineering, Engineering, or Life Science preferred. + Minimum of 15 years pharmaceutical manufacturing experience may be substituted for a degree. + Prior experience in process engineering and/or pharmaceutical production highly preferred. + Minimum of 1 year in OSD pharmaceutical operations is preferred. + Experience with equipment IQ/OQ/PQ preferred. + Experience in Lean Manufacturing/OpEx and Six Sigma preferred. **Why you should join Catalent:** + **Career growth** with a clear path and regular performance reviews + **Day-one benefits:** medical, dental, vision + **401(k) match** , tuition reimbursement, and wellness perks + **Paid time off:** 152 hours + 8 holidays + **Inclusive culture** with Employee Resource Groups and community initiatives + **Discounts** from 900+ merchants via Perkspot + **A mission-driven workplace** where your work helps save lives **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $99k-141k yearly est. 12d ago
  • Quality Associate II

    Catalent 4.4company rating

    Catalent job in Kansas City, MO

    Associate II, Quality Assurance Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring Associate II, Quality Assurance. The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. This is a full-time, onsite position. This is a 2nd shift position. (Monday-Friday 2:30pm-11pm) Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Create Certificate of Analysis Inspect bulk drug and packaged finished product Perform Component Inspection-primary/secondary Execute Cleaning Procedures Able to interpret and comply with specifications Component Release Packets Reclass Approvals Proficient in JD Edwards (IMS) Pre-Batch Record Review Post-Batch Record Review Post Packaging Study Release The Candidate: High School diploma or GED 1-3 years packaging experience or related industry experience, preferred Receives instruction, guidance and direction from others Uses existing procedures to solve routine problems Proactive to address work issues at the individual level Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form Mathematical and scientific reasoning ability Sufficient skills and knowledge in the use of computers and associated computer technology Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture 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 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree! WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories 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. 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 DisabilityAccommodations@catalent.com. 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $26k-36k yearly est. Auto-Apply 60d+ ago
  • Project Manager

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    · **Work Schedule: Monday-Friday 1st shift hours** · 100% on-site _Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects._ Catalent Pharma Solutions in Kansas City, MO is hiring a **Project Manager** . The Project Manger will lead Project teams in the management and successful delivery of assigned Projects/client relationships and will provide out of office cover as required. They will be the Catalent Advocate and the Client Advocate and will be responsible for developing solution-based approaches to project issues and customer relationship management. They will be responsible for communicating via teleconference as well as e-mail and other forms of client communication and will promote continuous improvement in all aspects of the job. This position will focus on professionalism and Customer Service Excellence when working with all internal and external clients and display a high degree of independent judgment and analyses to complete the responsibilities of this position. **The Role** + Attend and produce minutes and actions for client meetings/teleconferences/client visits and audits to support own assigned projects or PM team and understand full scope requirements to generate all required project documentation. + Manage inventory reporting and monitor and track client inventory in line with project requirements. + Set up clients on Fusion suite as required. Provide ongoing support for client use and password management. + Utilize and drive project timelines for day-to-day project activities. + Assist with departmental training and completion of training documentation. + Will mentor junior project managers and project coordinators. + Will review contracts, investigate, and propose solutions for disputed invoices, and effectively manage invoice queries to ensure timely resolution and payment. + Will become proficient with JDE and will perform all project setup entries and tracking as needed for all projects assigned as support or lead. Will also be responsible for marking financial milestones. + Assist in the preparation and regular review of Standing Operating Procedures relating to own areas of responsibility. + Any other duties as assigned. **The Candidate** + Bachelor's degree (or equivalent) in a related field or good educational standard with relevant practical experience. + 1 to 4 years' experience in a customer service or appropriate business-related area preferred. + Professional project management qualification is preferred. **Why you should join Catalent:** + ·Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $74k-107k yearly est. 60d+ ago
  • Distribution Project Coordinator

    Catalent Pharma Solutions 4.4company rating

    Catalent Pharma Solutions job in Kansas City, MO

    Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. **Catalent Pharma Solutions in Kansas City, MO is hiring for Distribution Project Coordinator.** The Kansas City CDS **Distribution Project Coordinator** is responsible for senior customer account management and distribution of clinical supplies across all studies. The primary responsibility of this position includes managing distribution for clinical trial protocols, maintaining strong client relationships, and working closely with project management for study specific setup. **This is a full-time, hourly, onsite position M-F 8am-4:30pm** **Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.** **The Role** + Coordinate and dispatch shipments of clinical trial material to sites, ensuring compliance with SOPs and the approved study-specific protocol. + Collaborate with Project Management to define distribution needs, align with project timelines, and ensure execution meets customer expectations/scope of services. + Act as the primary customer point of contact for distribution, leading internal and client meetings to facilitate project completion and issue resolution. + Manage the customer order pipeline and backlog, guiding S&OP teams and Distribution on scheduling and upcoming orders. + Generate, maintain, and review the Distribution Summary Protocol/Checklist for all shipments, ensuring conformance to Catalent Standards. + Anticipate, rectify, and report distribution problems to Project Management and the client; lead investigations and service complaint resolution. + Coordinate with the Distribution Department to schedule and manage international and large-volume shipments. + Support material management systems by reviewing distribution-specific material setup in ERP/IVRS and other client portals, including inventory monitoring. + Ensure financial and quality system accuracy by verifying billing codes, reviewing MRAPs, and documenting upstream quality issues. + Support quality assurance and team development by assisting with quality issue resolution, leading new hire training, and participating in customer audits and meetings. + Manages project initiation including kick-off meetings and protocol development. + Processes specialized purchase orders and coordinates new item number requests for distribution-only products. + Ensures timely and compliant shipment readiness, specifically handling dangerous goods documentation and daily operational escalations. + Acts as a subject matter expert for pharmaceutical import/export regulations and supports continuous process improvement projects. + All other duties as assigned **The Candidate** + Associate degree is required; Bachelor's degree is preferred. + ERP system experience; JD Edwards preferred + At least 2 years of Customer Service experience in a cGMP regulated environment is preferred. + Demonstrate strong analytical skills and problem-solving skills + Physical Requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 hours of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement - Let us help you finish your degree or start a new degree! + WellHub- program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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. 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 DisabilityAccommodations@catalent.com . 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 ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $41k-57k yearly est. 60d+ ago

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