Director of Quality - BioAnalytical
Catalent Pharma Solutions job in Kansas City, MO
**Director, Quality, BioAnalytical** 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 is hiring a Director of Quality who is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the site/division is compliant with regulatory, Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality at the site/division is the most responsible person for Quality. The Director of Quality is responsible for providing project guidance and support and work with customers to resolve quality concerns as appropriate. The Quality Director is the business partner to Operations and advisor to the General Manager of the site.
Location: Kansas, City, MO on-site position.
**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:**
+ Has functional responsibility for QA and QC and strategic responsibility as part of the Quality Leadership Team for BioAnalytical. Leadership of Our large molecule analytical team has over 25 years of experience;
+ Reporting to the VP, Quality, Biologics and sits on the extended Quality Leadership Team supporting the strategic direction on the BioAnalytical Business Unit;
+ Part of the global Catalent Leadership Tea; .
+ Initially responsible for oversight of the build out of the facilities, systems, and processes for BioAnalytical and the establishment of a high performing quality team and integration of the QMS into Catalent;
+ Continuously improve the agility, flexibility, speed, accuracy, and compliance of BioAnalytical performance by embedding the Catalent Way, as to how we do business and operate day to day;
+ Responsible for guiding the site/division for inspection readiness;
+ Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and implement Site Quality Plan, Quality Unit objectives and focused on ensuring specific focus upon best-in-class Quality Control related procedures;
+ Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations, with particular focus upon Analytical and Quality Control;
+ Ensure the QMS is agile and flexible to accommodate a diverse portfolio of service offerings consisting of a broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects. E.g. analytical support for drug substance, drug product, and intermediates for both innovator and biosimilar/bio better products;
+ Interface with all other departments to ensure compliance with cGMP and excellence in customer service.
+ Monitor site compliance to FDA, EU, and all other applicable requirements and ensure site procedures align with Corporate policies;
+ Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated;
+ Analyze, resolve, or assist in solving compliance and customer issues;
+ Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner;
**The Candidate:**
+ Bachelor's Degree in Chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred;
+ Eight (8) years' directly related experience in pharmaceutical fields including managerial roles;
+ Experience with sterile and blood drug product development, manufacturing and testing is strongly preferred;
+ Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred;
+ Must have a demonstrable record of implementing and maintaining and total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics;
+ Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards;
+ Experience in facilitating regulatory inspections;
+ Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control;
+ 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:**
+ Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
+ Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
+ Paid Time Off Programs including Vacation, banked time, and personal time.
+ Employee Reward and Recognition Programs.
+ Opportunities for professional and personal development.
**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 (*************************************************************************************************************************** .
Pharmaceutical Manufacturing Operator
Catalent Pharma Solutions job in Kansas City, MO
+ **Work Schedule:** Monday - Friday, 6:00AM - 2:30PM + **100% onsite** **Start your career where science meets purpose.** At **Catalent** , we don't just make medicine-we help people live better, longer lives. As a **Pharmaceutical** **Manufacturing Operator** , you'll be part of a team that transforms scientific breakthroughs into life-saving treatments. This is more than a job. It's a **career launchpad** in a growing industry with real impact.
**The Role:**
+ Operate and maintain pharmaceutical manufacturing equipment
+ Ensure product quality through visual inspection and documentation
+ Keep your workspace clean, safe, and compliant with cGMP standards
+ Collaborate with a team that values precision, safety, and innovation
+ Learn and grow with hands-on experience and mentorship
+ Other duties, as assigned
**The Candidate:**
+ High School Diploma or General Education Diploma is required
+ Prior experience in machine or equipment operations and troubleshooting is highly preferred
+ Mechanical knowledge is highly preferred
+ Well organized with ability to multitask and to work effectively under pressure to meet deadlines is highly desired
+ Individuals may be required to sit, stand, walk regularly and occasionally lift up to 40 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 (*************************************************************************************************************************** .
Buyer/Planner
Catalent Pharma Solutions job in Kansas City, MO
+ **Work Schedule:** M-F 1st shift + 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 Buyer/Planner.** The Kansas City Clinical Supply Services Buyer / Planner performs purchasing activities for the site including planning and procurement of all components necessary to complete packaging and distribution orders. This includes creating purchase orders, managing supplier relationships, and assisting in planning packaging jobs to ensure enough components are present.
**The Role:**
+ Performs analysis to determine optimal safety stock levels for stock components as well as re-order points for all materials based on lead times.
+ Maintain and manage suppliers meeting regularly to review lead times, pricing, and performance.
+ Ensures that sufficient material is available to support production and distribution, while not procuring excessive inventory that will be prone to obsolescence.
+ Purchase's components based on packaging timelines and material availability based on their assessment of inventory.
+ Creates and tracks Purchase Orders for Catalent supplied materials and ensures that purchase price is in accordance with the job estimate.
+ Request's specifications and quotes from suppliers based on departmental needs and Customer requirements for project related purchases.
+ Evaluate customer commodity specifications for accuracy and completeness and communicates specifications to vendors.
+ Initiates and maintains contact with suppliers for timely procurement of Catalent supplied components.
+ Requests required documentation from suppliers to properly receive purchased materials.
+ Manage the Material Tracker (or other designated site), as necessary - includes vendor follow-up for items that do not arrive as scheduled, updated need by dates due to timeline revision, etc.
+ Project timeline approval for procured materials.
+ Scheduling vendor deliveries with the Dock.
+ Help resolve/escalate Accounts Payable / invoicing issues.
+ Other duties as assigned.
**The Candidate:**
+ Bachelor's degree preferred with a minimum 2-4 years of related experience
+ OR Associates degree with equivalent professional experience,: 2-4 years of related experience
**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 (*************************************************************************************************************************** .
Returns Associate II
Catalent Pharma Solutions, Inc. job in Kansas City, MO
* Work Schedule: M-F 7am-3:30pm * 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 Returns Associate II. The Kansas City Clinical Supply Services Returns Associate II supports clinical trial projects through the processing of returned clinical trial medications that are returned by clinical research sites for destruction and ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Although the main focus is in Returned Goods and Destruction, 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 manual handling guidelines delineated in SOPs and MSDS
* Process returned clinical trial medications as delineated in the Returned Goods Summaries/Destruction Plans to ensure processing instructions are followed in accordance with SOPs and client authorized requests
* Follow safe handling procedures when utilizing manual lifting equipment to move material
* Prepare and complete documentation in compliance with SOPs and cGMP
* Reconcile returned clinical trial material and add to the appropriate inventory system
* Ensure daily targeted productivity goals are achieved
* Ensure a high quality standard work by reporting any deviations from the Returned Goods Summaries/Destruction instructions or SOP procedures to management
* Work with the Senior Returns Operator to complete verification of material for destruction
* Other duties as assigned
The Candidate:
* High School degree or equivalent
* 1-3 years of clinical trial Returned Goods Summaries/Destruction or related pharmaceutical operations experience preferred
* Ability to work in a team environment
* Self-motivated and proactive
* Proven written and verbal communication skills
* Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
* High attention to detail
* Ability to work effectively to meet competing workplace demands
* Basic computer skills - including, but not limited to e-mail, Microsoft Word & Excel, Internet Explorer
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.
Auto-ApplyPharmaceutical Development Technician III
Catalent Pharma Solutions, Inc. 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 Pharmaceutical Development Technician III 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 with a minimum of 5 years related experience.
* Associates degree or trade certification with a minimum of 2 years of related experience.
* Bachelor's degree with no prior experience required.
* Prior experience with compression or coating equipment preferred.
* Prior cGMP experience 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.
Auto-ApplyDistribution Project Coordinator
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 (*************************************************************************************************************************** .
Senior Validation Specialist I, BioAnalytics CSV & Compliance
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 (*************************************************************************************************************************** .
Packaging Coordinator
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 (*************************************************************************************************************************** .
Quality Control Senior Associate Scientist I
Catalent Pharma Solutions 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:**
+ 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 (*************************************************************************************************************************** .
Manager, Human Resources
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.
**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 (*************************************************************************************************************************** .
BioAnalytics Laboratory Technician
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 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 is hiring a BioAnalytics Laboratory Technician. The BioAnalytics Laboratory Technician supports the BioAnalytics team by performing basic analytical and Good Manufacturing Practices (GMP) testing, maintaining laboratory operations and equipment, and ensuring compliance with safety and quality standards. This role is ideal for individuals beginning their careers in life sciences or pharmaceutical industry. Training will be provided, and the technician will work under close supervision while developing technical skills and regulatory knowledge.
**This is a full-time on-site hourly position: Monday - Friday on 1st shift with core business hours between 8am-4pm.**
**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:**
+ Assist in performing analytical testing on pharmaceutical samples using validated methods under GMP conditions
+ Support GMP testing activities and maintain accurate documentation in laboratory notebooks and electronic systems
+ Maintain laboratory cleanliness and organization, including labware cleaning, inventory checks, and supply restocking
+ Follow written procedures and protocols to support method execution
+ Participate in training sessions and maintain current knowledge of Standard Operating Procedures (SOPs) and safety practices
+ Communicate effectively with team members and supervisors to ensure smooth workflow
+ Contribute to a safe and compliant laboratory environment
+ All other duties as assigned
**The Candidate:**
+ Minimum education required is a High School Diploma. Associate's or Bachelor's degree in scientific field is preferred
+ No prior laboratory experience required; internship or academic lab experience is a plus
+ Basic understanding of biological and chemical principles with willingness to learn analytical techniques such as ELISA, Capillary Electrophoresis, HPLC or UV-Vis
+ Familiarity with GMP concepts is a plus but not required
+ Strong attention to detail and ability to follow instructions
+ Must be proficient with computers, preferably using Microsoft Office Programs (Excel, Word, Outlook, etc.)
+ **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. May require use of Personal Protective Equipment (PPE)
**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 (*************************************************************************************************************************** .
Field Service Technician II - Kansas City, MO
Kansas City, MO job
This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job-you will find purpose and pride.
Your role at Baxter:
Our Field Service Technician II's primary responsibility is to perform complex repair work on all customer and company - owned medical equipment. In addition to the repair work, the FSII is also responsible for performing the same responsibilities as a FST I related to product readiness for patient utilization on a wide range of rental and customer owned medical products. This position requires operating a fleet vehicle in a safe manner as well as direct customer contact. Additionally, will provide 24/7 delivery, removal, and service support for products in service centers and customer accounts in a timely and professional manner. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most!
Your team:
* The field service team works within hospital and service setting environments to repair medical devices.
* Baxter offers dental, medical, and vision insurance, paid time off, parental leave, and more.
What You'll Do:
* Performs electronic, hydraulic and pneumatic systems troubleshooting and repair of assigned products.
* Ability to troubleshoot devices and repair any malfunctioning components.
* Ability to use the appropriate tools in making required adjustments and repairs.
* Ability to provide on-call coverage, up to 24/7 basis including weekends and holidays, which may require customer account visits.
* Ability to load, unload, and remove medical products, weighing up to 1680 pounds.
* Generate service revenue and complete activities required under service contract.
* Safely operate box truck vehicle or company car ranging in size from a cargo van up to a 26,000 pound truck.
What You'll Bring:
* Must be at least 21 years of age
* High school diploma or GED or equivalent experience
* Valid driver's license and driving record
* Basic mathematical skills - addition, subtraction, multiplication, and division
Preferred Qualifications
* Technical or Trade School training
* DOT physical card (assistance is provided)
* Experience with FDA regulated products
* Experience in customer service
Safety Requirements:
* Responsible for adhering to Hill-Rom Safety Procedures.
* Must wear personal protective equipment including but not limited to safety shoes, eye protection, gloves, and protective clothing. All equipment is provided.
* Frequently works in environments were biohazards could be present. i.e. Hospitals, Service Centers, and Depots
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The salary range for this position is $48,000-$66,000.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Quality Specialist II - Client Audits
Catalent Pharma Solutions, Inc. job in Kansas City, MO
* Shift: Monday - Friday 8am-5pm * 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 Quality Specialist II - Client Audits role. The Quality Specialist II - Client Audits is responsible for performing Client Audits for Catalent Kansas City.
The role:
* Back-up for Quality Specialist, Client Services for pre- and post- audit activities
* Responsible to lead any pre-audit meetings with internal stakeholders, such as Project Management, Operations, etc. to prepare for client audit
* Establish and maintain close working relationships with internal stake holders to aide in ensuring client needs are met during the audit
* Lead/participate in client audit (on-site or remote) with a consistent approach
* Demonstrate a working knowledge of KCM site SOPs and other GMP documentation
* Respond promptly, accurately and respectfully to all client audit requests. Upload documents to ShareVault, as needed
* Act as audit scribe by recording documents reviewed, summarize audit close-out meeting including any potential observations for internal distribution. Assist in maintaining audit records in TrackWise, as requested
* Meet deadlines according to agreed timeframes and communicate adjustments as needed
* All other duties as assigned
The candidate:
* Required a Bachelor's Degree preferably in Chemistry, Biology or other related field
* 2+ years of Scientific or Quality Assurance experience highly preferred
* Demonstrated knowledge of regulations and guidelines associated with cGMPs for pharmaceutical and biotech industries preferred
* Experienced with Microsoft Word, Excel, PowerPoint, TrackWise, SharePoint and Sharevault software system is a must
* Possess good communication and problem-solving skills highly desired
* Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 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 + 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.
Auto-ApplyDistribution Associate II
Catalent Pharma Solutions, Inc. job in Kansas City, MO
* Work Schedule: M-F 7:30am-3:30pm * 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.
Auto-ApplyTeam Lead, GMP Storage
Catalent Pharma Solutions, Inc. 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.
The Team Lead, GMP Storage role is responsible for overseeing daily operations of GMP storage facilities, ensuring full compliance with cGMP requirements while leading a team to safely manage, safeguard, and accurately track all GMP materials from receipt through finished goods completion. The Team Lead, GMP Storage role will be responsible for leading, training, and mentoring storage and warehouse staff to maintain high performance and adherence to SOPs.
This is a full-time, on-site salary position at our Kansas City, Missouri location.
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
* Lead, train, and mentor storage and warehouse staff to maintain high performance and adherence to SOPs. Coordinate receipt, inspection, labeling, and storage of GMP materials, including raw materials, intermediates, and finished goods.
* Manage inventory accuracy through regular cycle counts, reconciliations, and timely system updates in ERP system. Ensure proper segregation and handling of quarantined, released, rejected, and returned materials.
* Collaborate with Quality Assurance and Manufacturing teams to resolve deviations, CAPAs, and audit findings. Prepare for and actively participate in internal and external audits/inspections, providing accurate documentation and responses.
* Develop and update SOPs, work instructions, and training materials to reflect current best practices and regulatory requirements.
* Identify and implement process improvements to increase efficiency, reduce errors, and support continuous compliance.
* Coordinate with vendor to dispose of inventory materials appropriately.
* All other duties as assigned.
The Candidate:
* High School Diploma or General Education Diploma required
* 4+ years of warehouse and forklift work experience required
* Pharmaceutical or Medical Device industry experience strongly preferred
* Must be able to lift up to 35 pounds. Occasional requirement to stoop, kneel, crouch, or crawl. Must be able to stand on feet for hours at a time
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.
Auto-ApplySenior Associate Scientist I
Catalent Pharma Solutions job in Kansas City, MO
+ **Work Schedule:** Monday - Friday 1st shift + **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 **Senior Associate Scientist I** is responsible for performing analytical testing for the clinical dissolution team.
**The Role:**
+ Executes various laboratory test methods for dissolution
+ 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 related life science or physical science is required
+ Basic knowledge of current Good Manufacturing Practices (cGMP's) and Standard Operating Procedures (SOPs) 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 (*************************************************************************************************************************** .
Supervisor, Production
Catalent Pharma Solutions, Inc. job in Kansas City, MO
* Work Schedule: Sunday Evening - Friday Morning, 10:30 PM to 7:00 AM * 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.
Auto-ApplyManufacturing IT Systems Engineer
Catalent Pharma Solutions, Inc. job in Kansas City, MO
* Work Schedule: Monday - Friday 8:00AM - 5:00PM * 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 Manufacturing IT Systems Engineer is responsible for supporting the day-to-day business needs in the laboratory, manufacturing, and related support areas for continuous keep-up of various computerized and equipment systems.
The Role:
* Provides System Administration for various GMP applications including and not limited to network, software, and hardware support and troubleshooting of computerized systems and equipment for Laboratories (Analytics, QC, etc), Manufacturing, and other technology support systems
* Work closely with Catalent Quality, Operations, and Validation to deliver Computer System Validation (CSV) projects and support tasks involving integration and implementation of existing, upgraded and new systems, equipment, instruments and applications following GxP guidelines
* Troubleshoot technical IT incidents and determine solutions/workarounds by collaborating with system and/or equipment manufacturers/vendors and applicable 3rd party service providers
* Work closely with Validation and Technology Systems management to manage up to pre-defined scope, schedule, and budgets for technology projects; by means of working both independently and as a member of a project execution team
* Identifies and implements improvement opportunities for Laboratory, Manufacturing and Enterprise computer systems
* All other duties as assigned
The Candidate:
* Bachelor's Degree with a minimum of 1 year of IT experience
* Associate's degree with a minimum of 3 years' IT experience
* Prior experience with cGMP systems such as Laboratory Information Management System (LIMS), highly preferred
* Prior experience in computer networking, cybersecurity and data integrity 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.
Auto-ApplyFinance Director
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 (*************************************************************************************************************************** .
Project Manager
Catalent Pharma Solutions job in Kansas City, MO
+ **Work Schedule:** M-F 1st shift + 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._** _Overall responsibility for the leadership and management of projects as assigned. Depending upon experience and knowledge manage projects that maybe simple and residing in one business line or site, or complex and reside within multiple business lines or may cross multiple Catalent sites. May take on Global PM, Multi site or Lead PM for clients_
**The Role:**
+ Leads and builds multi-disciplinary project teams comprising of representatives from relevantfunctions and in some cases, cross-functional, multi-site activities for complex projects
+ Manages the execution of the customer's requirements in accordance with an agreed-upon program of activities to achieve established goals and deliverables
+ Compiles and maintains up-to-date project plans, identifies and captures new scope via proposals or change orders
+ Ensures that key milestones in agreement with internal/external customers are achieved and goodcommunication is maintained
+ Tracks progress of all activities against plan and notifies the relevant personnel of changes, potential delays and/or issues
+ Engrained in kick-off and methodical approach to managing the project throughout the duration ofthe project scope
+ Understands escalation pathway and when necessary, has the ability to mitigate
+ Demonstrates ability to facilitate risk assessment
**The Candidate:**
+ Bachelor's degree in a scientific discipline or equivalent combination ofeducation and experience (Associate's degree and 2+ years of experience OR high school diplomaand 4+ years of experience.
+ Approximately 2 years of experience in project management, the pharmaceuticalindustry or appropriate business-related area 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 (*************************************************************************************************************************** .