Novartis jobs in Saint Louis, MO

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Manage key product and stability testing groups and compliance activities to achieve site and corporate objectives. Specifically, this position will oversee 24/7 in-process laboratory testing, data release of raw materials, intermediates, stability, and finished product for the St. Louis and Greenville Plants, as well as the microbiological Center of Excellence supporting SpecGx. Additionally, this position will provide overall Quality Control (QC) leadership regarding (current Good Manufacturing Practices) cGMP compliance concerns and improvement for the Generics Business. Job Description ESSENTIAL FUNCTIONS: Ensure key turnaround timelines for customer service and compliance requirements are achieved Manage stability testing to achieve 100% on-time analysis for all stability protocol testing intervals Serve as the primary liaison for method transfers into the QC organization Accomplishes results through subordinate managers, supervisors, exempt specialist employees and non-exempt employees. Provide overall leadership to QC groups regarding cGMP compliance improvement and enhancement Serve as the Subject Matter Expert during compliance audits Study and improve various Quality processes through increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation Drive Quality consistency through revising or combining various analytical methods to ensure adequacy and quality with special emphasis on actual utility of methods under normal QC conditions Work with all Quality managers, supervisors and analysts to address any laboratory concerns regarding safety, methods, procedures, or operation Act as a liaison between the labs and manufacturing/ R&D in implementing special projects, production campaigns, or assist with validations or method transfers Works with various reports and QC groups to ensure compliance to Environmental Health and Safety and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in our laboratories Ensure compliance with and oversee compendia affairs for SpecGx MINIMUM REQUIREMENTS: Education: BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. Experience: Minimum of 15 years related experience in Quality with 10 years management experience required. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. Preferred Skills/Qualifications: Excellent communication and leadership skills. Ability to work in and promote a team environment. Working knowledge of Six Sigma and/or Lean manufacturing tools. Complete understanding and application of principles, concepts, practices, and standards within discipline. Ability to lead and influence people. Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. Knowledge of US and International pharmaceutical manufacturing regulations. Other Skills: Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results COMPETENCIES: Decision Quality, Developing Direct Reports, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving, Building Effective Teams RELATIONSHIP WITH OTHERS: Reports to the Sr Director, Quality and Regulatory Affairs. Manages group of exempt direct reports. Develops strategic objectives for groups managed. Contact with FDA as subject matter expert during site inspections. Regular contacts including Logistics, Marketing, R&D, Site Production Leaders, HSE, and DEA. WORKING CONDITIONS: 25% Laboratory exposure to plant products, solvents, reagents, some of which are hazardous or potent compounds 75% Office environment which requires sitting for long periods of time and computer use. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Plant Security Supervisor at Par Health is responsible for overseeing the security operations at several facilities, ensuring the safety and security of personnel and property. This role involves supervising a team of security monitors and officers and enforcing security policies and procedures. The supervisor will also engage in continuous improvement initiatives and collaborate with site leadership to align security strategies with organizational goals. Job Description ESSENTIAL FUNCTIONS: Supervise daily security operations to ensure safety across the St. Louis and Webster Groves plants. Enforce Security Procedures for Controlled Substance areas in both locations. Prevent diversion as stated in Title 21 of the Code of Federal Regulations, and to maintain our DEA Registrations at both locations. Maintain plant safety goals and objectives. Maintain and repair all Vaults at both locations. Work with the DEA when additions/upgrades and new security systems are added at both locations Recruit, train, and coach security monitors to deliver exceptional support, conduct performance evaluations and foster a culture of teamwork, accountability, and continuous improvement. Provides supervision for a team of staff security monitors and security officers. Partner with Employee Health & Safety to maintain OSHA compliance, update safety manuals, and support emergency action plans. Administrative duties include approving timesheets, manage scheduling, and assist with security systems such as ID badges, camera monitoring, and Best Lock Systems and Alarm Systems for both locations and coordinate necessary repairs. Essential Role: Serve as an essential staff member-available to work all scheduled shifts in varying conditions as demands dictate. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Ensure that monthly alarm tests are conducted in Controlled Substance Manufacturing areas. Perform quarterly meetings with Security Monitors. Provide weekly report to Security Manager. Work with Building personnel on requested special projects throughout the year. Maintain the Security Vehicle used at the Plant. MINIMUM REQUIREMENTS: High School Graduate required. Associate's degree or graduate of accredited law enforcement academy, preferred Demonstrated ability to communicate effectively/clearly at all levels in a friendly manner Must be able to maintain a valid Driver's License 2 years of demonstrated supervisor experience required Ability to be physically mobile, and able to sit, stand, and walk for 8 to 13-hour shifts. Excellent communication skills. Must be able to work in areas containing dust, varying noise and temperature levels, lighting, vibrations, and air quality. Must present a professional appearance and demeanor at all times. Regular and punctual attendance is required. ORGANIZATIONAL RELATIONSHIPS/SCOPE: This position reports to the Security Director of Par Health. This position requires interaction with many layers of management and non-management personnel at the Plant and Webster Groves. Working relationships outside of the Plant include DEA, local law enforcement personnel, ADT, Best Access, Will Electronics, and various construction companies. WORKING CONDITIONS: Duties are performed throughout the plant and at Webster Groves in both hazardous and non-hazardous areas. Work is regularly performed in both controlled and non-controlled substance buildings. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods. Job Description ESSENTIAL FUNCTIONS: Follow good documentation practices for the accurate and timely documentation of all activities. Perform wet chemistry and instrumentation testing. Follow site HSE Policies. Assist with establishing and maintaining safe work standards in the lab. Peer review all levels of work. Conducts lab investigations. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: LIMS entry of data Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter Maintain instrument readiness MINIMUM REQUIREMENTS: Education: High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred. Experience: Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred. Preferred Skills/Qualifications: Working knowledge of wet chemistry required Working knowledge of instrumentation (GC/LC, UV, AA). Experience in a cGMP environment is preferred. Basic computer skills and familiarity with Microsoft Office Suite. Substantial acquaintance with and understanding of application of basic principles, theories and concept. Use and/or Basic knowledge of industry practices and standards. Chromatography (GC/LC) and Spectroscopy experience a plus. COMPETENCIES: Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management ORGANIZATIONAL RELATIONSHIP/SCOPE: Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters. WORKING CONDITIONS: 80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 20% Office environment. Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: At MilliporeSigma, as the GMP Packaging Technician 4 - 1st Shift at our Cherokee site, will play a key role within our GMP Operations Systems & Support team. This team supports Manufacturing through various functions including buffer manufacturing, training, compliance, equipment and facility cleaning, and raw material sampling. Expectations of the GMP Operations System & Support team are to ensure compliance and readiness within our GMP Manufacturing teams, ultimately enabling high manufacturing success. Job duties include: Shift hours: Monday - Friday - 1st shift, with on call hours off shift as business needs require Adhere to procedures consistent with, and established according to, current Good Manufacturing Practices Documentation following GDP (Good Documentation Practices) guidelines Prepare Raw Material paperwork (ae. Bulk Sampling form, Sampling Line Clearance, SDS) Prepare for GMP packaging and labeling events (including MPF and label request, label review, and label kitting) and execute packaging, labeling, and raw material sampling events. Track direct event hours and component usage (via cost tracking sheets) and perform various printing tasks, including Zebra labels, LIMS documents, and SAP Storage Unit Labels for finished goods as required. Manage inventory sufficiency (including stocking supplies and assuring adequate levels), order components via SAP, reconcile inventory through cycle count, and generate TOs for materials/components as applicable. Enter information into the Product History spreadsheet to accurately track the status of each product moving through the GMP Packaging group Provide input in deviation investigations through interviews and support implementations of CAPA actions Achieve departmental goals and objectives safely and in compliance with all applicable regulations (e.g., FDA, OSHA), maintaining up-to-date training and audit readiness, and collaborating cross-functionally with departments such as QC, QA, Materials Management, Engineering, and Maintenance Provide support for event coordination and maintain packaging areas in an audit-ready state. Physical Attributes: Stand for extended periods of time. Lift, push, and or pull up to 50lbs. Wear mask, safety shoes, gloves, Tyvek suits, respirator, and related personal protective equipment Who You Are: Minimum Qualification: High School Diploma or GED 1+ years' experience in a packaging / pharmaceutical operations environment Preferred Qualifications: GMP and GDP experience Experience working with and in proximity of hazardous chemicals and human source materials SAP knowledge Demonstrate basic math skills (including the metric system), legible handwriting, and strong oral and written communication abilities Pay Range for this position: $25.00 - $4200. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Provides revenue contract, pricing and commercial reporting support for the SpecGx business. Many of the responsibilities below require peer review and approval amongst the Contracts team members. Job Description SUMMARY OF POSITION: Provides revenue contract, pricing and commercial reporting support for the SpecGx business. Many of the responsibilities below require peer review and approval amongst the Contracts team members. Agreement Preparation and Review Utilize the pricing analysis models to prepare standard and non-standard contract documents in coordination with Pricing, Product Management, and/or Sales organizations Work closely with Legal and Finance to ensure all deals are compliant with business policies and function as a liaison with other departments (Customer Service, Data Integrity, Credit, Rebates) to ensure proposed terms are supported by these functional areas Contract Administration Set up and maintain contract files utilizing document management systems Load contract pricing, initial membership, and rebates programs in the Revenue Management System (Model N) Respond to various pricing and contract inquiries and resolve price discrepancies on chargeback submissions Track project workflow and maintain proper audit support for special projects and price changes. Support Audit Control by attending bi-weekly Open Items Calls for Generics and Addiction Treatment Manage expiring contracts in Model N and drive annual contract performance reviews Maintain Product and Pricing in McKesson's portal, “ARK” Run daily “Bid Awards” and send notifications to appropriate wholesalers Addiction Treatment Team Support Set up new Addiction Treatment Customer Contracts Work with Product Monitoring to prepare Credit Request and send to customer service to process Assure that internal membership groups are set up correctly in Model N and resolve any pricing/rebate issues related to membership Prepare annual across the board price increases for each calendar year Suspicious Order Monitoring (“SOM”) related tasks Support the SOM program by updating the Trade Partner list; preparing applicable customer notifications; and performing document discovery Partner System Responsible for contract set up in Partner for International and API contracts; enter pricing; resolving pricing or membership issues; and preparing pricing offers Other Duties as assigned SCOPE OF POSITION / RELATIONSHIP WITH OTHERS: This role reports to Manager, Contracting & Reporting, and works closely with Pricing, Finance, Legal, Sales, Product Management, Customer Service, Wholesalers, Data Integrity, SOM Team, and Customers as well as all levels of Mallinckrodt management and project teams Education: Associates degree preferred in Business, Accounting or Finance field or equivalent experience; Bachelor's degree a plus Experience: 1 to 3 years of experience with customer contracting, reporting, contract operations, or customer service; and experience with Accounts Receivable/Payable, Cognos, Excel, Word, AS400 Queries, rf Xcel, invoicing systems Preferred Skills/Qualifications: Working knowledge of Mallinckrodt's order management, customers and product lines Report writing skills (i.e., Cognos, Power BI) Ability to identify issues and find appropriate resolution Demonstrated understanding of contract language as it relates to contract setup and maintenance to ensure accurate pricing and calculation of customer rebates and accurate representation of intended financial implications Other Skills/Competencies: Strong communication skills Strong attention to detail and system oriented Demonstrated analytical and problem solving skills Ability to work independently and with a team Strong sense of urgency with the ability to prioritize Ability to operate in a fast-paced environment, and adapt positively to change EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison Job Category: Scientific/Technology All Job Posting Locations: Kansas City, Kansas, United States, Kansas City, Missouri, United States, Little Rock, Arkansas, United States, Oklahoma City, Oklahoma, United States, Omaha, Nebraska, United States, St. Louis, Missouri, United States Job Description: Johnson & Johnson Innovative Medicine is recruiting for a Medical Science Liaison, GU Medical Oncology in the territory comprise Medical Science Liaison, GU - Missouri, Kansas, Nebraska, Oklahoma, Arkansas. About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine The Medical Science Liaison (MSL) is responsible for providing fair balanced, objective, scientific information and education to health care professionals and to internal partners as required by scientific and business needs. The MSL is considered the scientific and clinical source for current and future Janssen Oncology products. The MSL is also responsible for staying abreast of current scientific and treatment landscape trends in therapeutic areas of interest. The MSL provides research support for company and investigator initiated research. The MSL is responsible for building external relationships with the health care provider team (MD, PA, NP, RN, Pharm.D.) and developing and managing a geographical territory. These relationships and engagements will include both virtual & in person. The MSL is responsible for developing and maintaining a territory strategic plan, which includes clinical activities with identified OLs, institutions, community practices, pathways influencers and advocacy organizations. The MSL role is the entry level position within the MSL organization. The MSL will develop a competency in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination As the MSL grows in the role, they will be expected to identify and compliantly collaborate with field based partners to ensure support of the health care providers which will positively impact the patients that they care for. The MSL will develop in the area of Agility, applying the competencies of Change Management, Time Management and Innovation to the role. The MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical position which requires travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 60% Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory with effective data delivery. Demonstrates the ability to build community and academic opinion leader partnerships through establishing relationships and conducts scientific exchange with community and institutional HCPs Respond to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence in to real life practice to meet customer needs Presents data and information in a manner appropriate to the audience and request. Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people. Anticipates the responses of various individuals and teams based on their vantage point and perspective Listen for and collect medical insights and submit for analysis Executes Research Initiatives: Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings Maintains a strong scientific acumen Actively participate in journal club through scientific dialogue,demonstrate understanding of current standard of care, and regularly share scientific news with team members Sets aside time for self-driven learnings on current scientific landscape Attends scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community Medical insights: Actively listens for, documents, and shares medical insight Support of Department Operations and Internal Partners: Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities) Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development Communicates and collaborates with all field based partners, RWV&E, and other Oncology MSL teams on a routine basis. Develops thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; MAF SOPs and guidelines) Qualifications: • PharmD, PhD, MD, or other advanced medical degree NP (Nurse Practitioner), PA (Physician Assistant) • Minimum of 2+ years of relevant work experience, which can include clinical, research, or related pharma work experience. • Significant experience giving presentations. • Ability to support travel up to 70% which includes overnight travel, including some weekend commitments such as meetings, congresses, etc. • A valid U.S. driver's license and clean driving record. • Reside within the defined territory or eligible for relocation Preferred: • Knowledge or experience in Oncology and/or Urology. • Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. • Prior experience as an MSL The anticipated base salary for this position is $115,000 and $197,800 . This position is eligible for a company car through the Company's FLEET program. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Manager, Controlled Substances Compliance position is part of the Controlled Substances Compliance Team within the Mallinckrodt Specialty Generics business. The Manager is responsible for implementing, executing, and enhancing our internal controlled substances analytics and compliance program. This position is at the center of the Company's industry-leading Anti-Diversion Program, which focuses on addressing the issues of diversion and abuse of our controlled substances. As a subject matter expert on DEA regulations and a member of the Company's Suspicious Order Monitoring Team (SOMT), this position is instrumental in fulfilling the Company's obligation to maintain the required closed system of narcotics distribution by implementing and improving our systems to detect and report suspicious orders of finished dosage products and Active Pharmaceutical Ingredients (API) produced by the Company. Job Description Essential Functions Suspicious Order Monitoring Regularly review direct and downstream customer algorithms and thresholds to ensure systems are flagging orders appropriately Customer Segmentation - Conduct regular analysis and direct updates to segmentation into the inventory management system SOM Enhancements - Work with corporate Information Technology personnel when enhancements to the SOM system are required Primary Responsibility for conducting ongoing reviews of internal chargeback data for all controlled substance products; independently investigate “red flags” and prepare pharmacy review cover sheets Solicit due diligence feedback from distributors regarding pharmacies facing restriction Collect and analyze data from disparate sources (DEA ARCOS data, census, state pharmacy board disciplinary information, social media information related to the pharmacy, information regarding proximity to pharmacies and other healthcare institutions, etc.) in order to make recommendations for restrictions and reinstatements according to standard operating procedures Manage a program of media/internet source reviews to identify downstream customers to be further investigated Independently investigate downstream customers identified Document investigation Make recommendations for restrictions based upon the outcome of the investigation Facilitate SOMT Meetings - Serves as member of the SOMT and facilitates media/internet and chargeback review meetings to include preparing agendas and documenting meeting minutes Prepare and send restriction letters to customers and DEA Direct Customer Orders Reviewed & Dispositioned Provide Second Level SOM review of direct customer orders of controlled substances Review customer forecasts for focus products Contacts direct customers for due diligence information when needed. Know Your Customer (KYC) Program Responsible for reviewing and updating customer due diligence questionnaires Review and assess responses to questionnaires completed by customers Schedules and participates in customer reviews with CS Compliance staff. Maintains KYC documents for all direct customers in accordance with SOPs. Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. Internal Audit Program Development & Execution Evaluate effectiveness of standard operating procedures, identify changes that would enhance the process, and ensure that all change control documentation is implemented Directly participate in DEA inspections/audits. This participation will require skilled personal interface with external regulatory personnel Conducts mock DEA audits Maintain communications log of all information requests from law enforcement and regulatory agencies in accordance with company policy Minimum Requirements Bachelor's Degree 8 years of experience in Controlled Substance Compliance as an investigator/regulator Previous experience with DEA recordkeeping and ARCOS reporting Experience in data analytics including MS Excel pivot table work, charts, and graphs Self-motivated with ability to work with various internal departments and external contacts Understanding of and ability to interpret regulations Ability to take initiative and act without direction when appropriate and ability to “think and act on his/her feet” Knowledge of regulatory reporting systems Excellent oral and written communication skills Detail-oriented Working knowledge of Microsoft Office: Excel, PowerPoint, Word Organizational Relationship/Scope Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies. Escalation Process Adherence: Understands the scope of his/her decision-making authority; sorts through the facts and personal knowledge level to determine if an issue can be managed effectively or if it needs to be elevated to someone with additional knowledge that would impact the outcome; does not let much time lapse prior to making the decision to let others know; clearly and concisely explains the issue to senior leadership; ensures handoff to the next level has occurred. Priority Setting: Spends his/her time and the time of others on what is important; quickly zeros in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus. Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others cannot; can simplify complex processes; gets more out of fewer resources. Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities. Working Conditions This position is preferred office based in St. Louis, Missouri. This position is eligible to be field based with a travel requirement of at least 50%. Travel is inclusive of frequent visits to other Mallinckrodt and/or Customer sites that may include traditional office setting, production areas, loading docks, and laboratories. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Pharmaceutical Technician executes all production and packaging processes while adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply at the Fenton Manufacturing Plant. Under the supervision of the Manufacturing Supervisor, technicians will weigh raw materials, blend raw materials, process active compounds into final dosage form and package final product for shipment. The technician is expected to fully participate in both departmental projects and any quality working teams. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. Job Description ESSENTIAL FUNCTIONS: Operates equipment required in the manufacture of pharmaceutical products including, sifters, blenders, tablet press, fluid bed, granulation, encapsulation, pan coaters and packaging Monitor the production process, make periodic checks and adjust equipment or work practices to maximize production efficiency, yields, quality and safety. Accurately reports production and ensures reports are completed as required Prepares and submits samples to Quality Control Laboratory. Reviews, writes and update SOP's Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure Perform basic maintenance, trouble shooting, minor repairs, machine setup and breakdown Perform inventory functions including but not limited to WIP, Cycle Counts, receiving/shipping functions, etc. Follows all EHS rules and regulations. Take proactive steps to ensure a safe work environment and ensure safety issues are corrected. Complies with all site security requirements. Performs lock-out/tag-out procedures according to SOPs. Follows safe working practices in the execution of their assigned duties. Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies. Ensures that processes comply with all cGMP regulations in regards to process and cleaning validations. Participates in investigations and corrective actions Participate and provide direction in process improvements, reviews corrective actions to provide input. Troubleshoot equipment, processes and production problems with appropriate personnel. Perform other duties as assigned. MINIMUM REQUIREMENTS: Education: High School diploma or GED. Experience: Minimum of 1-5 years' experience working in pharmaceutical industry. Solid oral dose production experience is preferred. Preferred Skills/Qualifications: Excellent communication skills, both written and oral Strong attention to details Mechanical knowledge of production equipment Ability to work in and promote a team environment. Knowledge of cGMP regulations Other Skills: Strong working knowledge of Microsoft Office products RELATIONSHIPS WITH OTHERS: The Pharmaceutical Technician supports the pharmaceutical manufacturing process and may be assigned a general plant support role. This position interacts with production supervisor, production technicians, production managers, maintenance, engineering, purchasing, safety and training. WORKING CONDITIONS: Works majority of time on the production floor in manufacturing with some office type environment work. Working hours are regular daytime hours but are subject to change. The time spent on the production floor may be for extended periods of time within a manufacturing facility. Must be willing and able to wear PPE including steel-toed shoes, safety glasses, earplugs, and other devices or equipment that may be required. Heavy physical demand requires frequent moving, pushing, pulling, rolling and dumping of up to 100 kg and manual lifting of up to 25 kg. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. Now offering daily pay to our hourly team members! Don't Wait For Payday. Get Your Pay Today. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations. How you will contribute: · You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team. · You will screen new and repeat donors and take and record donor vital signs and finger stick results. · You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation. · You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures. · You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays. What you bring to Takeda: · High school diploma or equivalent · Ability to walk and/or stand for the entire work shift · Will work evenings, weekends, and holidays · Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees · Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. · Fine motor coordination, depth perception, and ability to hear equipment from a distance · Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear · 1 or more years minimum experience working in a customer or patient facing role is helpful More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - MO - Saint Ann U.S. Starting Hourly Wage: $16.00 The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - MO - Saint AnnWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: MedTech Sales Job Sub Function: Clinical Sales - Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Danvers, Massachusetts, United States of America, Springfield, Illinois, United States, St. Louis, Missouri, United States Job Description: About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech This is a field-based role. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Purpose: The Physician Program Director (PPD) focuses on establishing formal Impella programs through sustainable relationships with account stakeholders and key opinion leaders (KOLs) within the field of hemodynamic support. KOL Engagement The PPD is responsible for developing and managing strategic relationships with key opinion leaders, thought leaders, and subject matter experts to support the organization's scientific, medical and commercial goals. This role ensures effective engagement, collaboration, and communication between the company and its network of experts to enhance brand credibility, education, and innovation. The PPD represents all aspects of Abiomed and acts as a field liaison to connect hospitals to internal resources such as the medical office, research, marketing, and executive teams. Program Resourcing The PPD will be responsible for collaborating with hospitals and hospital administrators to identify areas for program efficiencies through best practice implementation, protocol development, and workflow improvement, ensuring long-term program sustainability. The PPD will work to identify program gaps and align internal resources as appropriate to support the hospitals' goals. The PPD will collaborate with systems of care and Integrated Delivery Networks (IDNs) to support the implementation of best practices across the hospitals within the system. Principle Duties and Responsibilities: * Develop and implement a comprehensive KOL engagement strategy aligned with brand and therapeutic area objectives. * Develop sustainable relationships with designated accounts, health systems, key opinion leaders and stakeholders, to impact formalization of Impella programs and optimize outcomes. * Understand hospital market dynamics, uncover gaps in operational efficiency and patient care, and deploy appropriate tools that will ultimately allow us to reach more patients * Present complex health economic information to influential and diverse groups in a way that is engaging, credible, and easily understood. * Advocate on behalf of heart recovery programs to health system administration & engage with hospital administrators to gain alignment on projects. * Identify and develop new and emerging key opinion leaders through key customer visits, HQ executive programs, regional education courses and local programs * Serve as a corporate liaison between Key Opinion Leaders, IDNs, Healthcare System leaders, and Abiomed's Executive team, Management, Marketing, Clinical Research and Sales. Collaborate cross functionally with internal partners to align KOL initiatives. Execute and facilitate important and integral customer meetings at major medical tradeshows * Communicate routinely with all members of the sales and Abiomed leadership team as outlined Job Qualifications: * BA/BS required. MBS or MBA preferred. * 4 or more successful years of sales experience within Abiomed OR >7 years of related industry sales experience and proven success * Prior KOL management experience or existing relationships in geographic area * Prior experience working collaboratively with C-Suite hospital administrators * Prior experience partnering with leaders of IDNs or systems of care * Must be able to travel overnight extensively (70% depending on geography) * Strong understanding of US health care policy and payment systems, including hospital and physician reimbursement. * Outstanding interpersonal skills, experienced developing relationships at all organizational levels to influence business objectives. * Ability to balance strategic thinking with intricate planning and strong tactical execution. * Demonstrates responsiveness and a sense of urgency * Ability to prioritize work and manage multiple priorities * Demonstrated ability to project manage effectively and drive initiatives to completion * Excellent written and oral communication skills, including strong presentation skills. * Mastery of cardiac anatomy and clinical data. * Proficient in computer skills, with strong expertise in Microsoft Excel, Word, and PowerPoint for data analysis, documentation, and presentations. The expected base pay range for this position is $132,000 - $211,600. The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. This position is eligible for a company car allowance through the Company's FLEET program. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: * Vacation -120 hours per calendar year * Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year * Holiday pay, including Floating Holidays -13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child * Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member * Caregiver Leave - 10 days * Volunteer Leave - 4 days * Military Spouse Time-Off - 80 hours For additional general information on Company benefits, please go to: * ********************************************* This job posting is anticipated to close on 11/12/2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills:

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Specialist, Controlled Substances Compliance - Analyst position reviews direct customer orders flagged for review and participates in a multi-level process to evaluate and recommend disposition of the order in accordance with company policy; review customer questionnaires for completeness and accuracy and conducts appropriate follow-up with customers as necessary; audits internal processes to ensure compliance with company policies and procedures; facilitates activities of the Suspicious Order Monitoring Team (SOMT). Job Description Essential Functions Direct Customer Orders Reviewed & Dispositioned Conducts first-level review of direct customer orders flagged by company algorithms and recommends whether they may be released per SOPs. Coordinates with the Commercial business unit representatives (National Account Directors and Product Managers) to gather the information (forecasts, etc) necessary to aid decision making on flagged orders. Review customer forecasts for focus products Contacts direct customers for due diligence information when needed. Creates and maintains the documentation necessary to satisfy the DEA's requirement for the reporting of suspicious orders per record retention policy. Reviews Direct Order Dashboard and other company data to detect patterns that may be related to a specific customer account. Track metrics for reporting to the Suspicious Order Monitoring Team. Know Your Customer (KYC) Program Reviews direct customer KYC questionnaires for completeness and thoroughness. Schedules and participates in customer reviews with CS Compliance staff. Maintains KYC documents for all direct customers in accordance with SOPs. Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. Support Suspicious Order Monitoring Team Assist with managing a program of media/internet source reviews to identify downstream customers to be further investigated. Facilitate SOMT Meetings - Preparing meeting minutes. Prepare and send notices to DEA of pharmacy restrictions Minimum Requirements Education Bachelor's degree or equivalent relevant experience, including statistical analysis preferred. Experience Prior experience in Controlled Substance Compliance in the private sector or as a government investigator/regulator preferred. Preferred Skills/Competencies Experience in data analytics including Excel pivot tables and charts, graphs. Working knowledge of Word and PowerPoint. Experience auditing internal processes to ensure compliance with regulations and company policies and procedures. Self-motivated; able to work with various departments internally and contacts outside of the organization. Must take initiative and act without direction when appropriate. Knowledge of regulatory reporting systems. Previous experience with DEA recordkeeping. Excellent oral and written communication skills. Detail oriented. Strong organizational skills. Organizational Relationship/Scope Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies. Escalation Process Adherence: Understands the scope of his/her decision-making authority; sorts through the facts and personal knowledge level to determine if an issue can be managed effectively or if it needs to be elevated to someone with additional knowledge that would impact the outcome; does not much let time lapse prior to making the decision to let others know; clearly and concisely explains the issue to senior leadership; ensures handoff to the next level has occurred. Priority Setting: Spends his/her time and the time of others on what's important; quickly zeros in on the critical few and sets the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus. Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources. Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more dome in less time than others; can attend to a broader range of activities. Working Conditions Physical/visual activities or demands that are commonly associated with the performance of the functions of this job Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories. Handling of pharmaceutical product (packaged/bulk). Finger dexterity required to operate computer keyboard. Hearing at a level to enable one to hear normal conversation. Visual requirements of having the ability to read the computer screen, documents. Must wear safety glasses and other protective items as required. Sitting 75% of the day; standing or walking 25%. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. * $3000 sign-on bonus if hired for this position* Your Role: At MilliporeSigma, as the Manufacturing Supervisor-Cell Culture Media-2nd Shift, at our 3506 S. Broadway location, your primary responsibility is to manage and supervise personnel and resources for manufacturing site. The Supervisor will develop subordinates' knowledge and skills to improve performance and expand abilities. You will also coordinate the group's efforts to accomplish departmental and company objectives in a safe manner and in compliance with all applicable federal, state and company regulations (OSHA, USDA, ExciPact, ISO, etc.). Select, train, develop, motivate and evaluate employees. Ensure tasks are completed in accordance with approved SOP's, OJTs and other protocols. Provide strong avenue of communication for employees and ensure information is passed on to subordinates timely through weekly meetings and shift pass downs. Communicate the group's status, data and feedback to management. Direct groups efforts toward ISCO Excellence and company goals. Represent the team in Material Review Board (MRB) and Production scheduling meetings. Plan for short-term and long-term responses to customer needs and company goals. Contribute to the support of customer relations and interact with the customers and represent the company during audits. May occasionally perform duties of direct reports. Physical Attributes: Lift, push, pull or move up to 35 lbs independantly, 50lb assisted Wear appropriate PPE such as necessary (e.g., safety shoes and safety goggles) Shift: Monday-Friday 1:30pm to 10:30pm (with potential for off-shift/weekend work) Who you Are: Minimum Qualifications: Bachelor's Degree in a scientific discipline (Chemistry, Biochemistry, etc.) or engineering discipline (Chemical, Mechanical, etc.) with 3+ years of manufacturing experience OR High School Diploma or GED and 7+ years of manufacturing experience 2+ years leadership experience Preferred Qualifications: 3+ years life science manufacturing experience Familiarity with basic chemistry and science principles Six Sigma Green Belt Experience with Digital/Smart Manufacturing concepts Ability to manage, motivate and develop employees Knowledge of various processing techniques and equipment Knowledge of asceptic manufacturing processes Good interpersonal, conflict resolution, motivation, and leadership skills Strong verbal and written communication skills, to include the ability to communicate with various disciplines and levels both one-on-one and in group communication Pay Range for this position - $81,200 to $138,400/year The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. RSREMD What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Lead Validation Engineer will create, review and/or execute primary qualification and validation activities for equipment, instrumentation, utilities, and manufacturing processes. The overall objective of the position is to ensure product quality and site compliance to regulatory requirements. The Lead Validation Engineer interfaces with Manufacturing, Quality Assurance, Quality Control, Engineering and R&D to obtain the process, equipment, controls, and installation support documents necessary for protocol development and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other validation activities as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate will also be responsible for the data integrity program, including management of assessments and implementations of associated mitigations for both laboratories and manufacturing. Job Description ESSENTIAL FUNCTIONS/SKILLS: Development and execution of documents including but not limited to: FAT, SAT, IQ, OQ, PQ, and PV Review and approval of validation documents including but not limited to: GxP Assessment, Risk Assessment, Part 11/Annex 11 Assessment, Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS, DS and Traceability Matrix. Familiar with Development, QA and Production environment terminology and testing strategies. Complete equipment periodic review Responsible for change management validation functional review Temperature mapping of controlled environments Development and review of laboratory equipment qualification protocols Development and review of cleaning validation protocols. Basic understanding of LD50/HBEL derived maximum carryover limits Collection of cleaning samples - swab / rinse, etc. as required Performs validation document review and approval Responsible for validation procedures, template creation and software validation process improvements Reviews/approves validation deviation investigation Develops validation plans for multiple site implementation Responsible for document management including scanning and archival of validation documents Familiar with data integrity guidance from MHRA and FDA Management of data integrity gap assessments and remediation Performs equipment/system/process level risk assessments per ICH Q9 guidelines DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Provides audit support - customer/regulatory /corporate, etc. as needed Perform various risk assessments with a cross functional group Participate in site Environmental Health and Safety, Performance Excellence, Lean, Quality Improvement Plans, and related initiatives designed to meet key business objectives MINIMUM REQUIREMENTS: Education: Bachelor's degree in a science/engineering related field is preferable with related technical background Experience: Minimum of 10 years' experience in review/approving validation in a pharmaceutical manufacturing environment. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 , Q9, and Q11 preferred. Preferred Skills/Qualifications: Excellent written and oral communication and leadership skills. Ability to lead and influence people. Ability to work in and promote a team environment. Basic understanding of Six Sigma and/or Lean manufacturing tools. Complete understanding and application of principles, concepts, practices, and standards within discipline. Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. Knowledge of US and International pharmaceutical manufacturing regulations. Experience using thermometric studies instrumentation (Kaye Validator/ValProbes/ Ellab) COMPETENCIES: Focus, Drive for Results, Managing Through Systems, Written Communication, Customer Focus, Listening, Organizing, Comfort around Higher Management, Multi-tasking, Prioritization, Risk Based Decision Making, Managing Diversity, Motivating Others RELATIONSHIPS WITH OTHERS: Directly and indirectly works with colleagues in other groups; including Manufacturing, Operations, Quality Control, Engineering, and R&D to achieve key operational objectives. Interacts with IT, site Business Owners, Technical leads. Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. Need to interact effectively with others throughout the organization to complete Data Integrity assessments and implementation of applicable mitigations. PHYSICAL/VISUAL ACTIVITIES OR DEMANDS: Exert a negligible amount of force continuously and up to 20 pounds of force occasionally to lift, carry, push, pull or move objects. Involves sitting, walking, and standing, reaching, talking and hearing. Flow of work and character of duties involve normal mental and visual attention much or all of the time. ORGANIZATIONAL RELATIONSHIP/SCOPE: Reports to the Manager Quality Validation. Must be self-directed to manage validation activities (local and remote sites). Operates independently under limited supervision. WORKING CONDITIONS: 80% office environment which includes sitting for long periods of time and computer use. Less than 10% manufacturing environment exposure including temperature, noise, chemical or potent compound exposure. Less than 10% of laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Pharmaceutical Sales Job Sub Function: Sales - Oncology/Hematology (Commission) Job Category: Professional All Job Posting Locations: St. Louis, Missouri, United States Job Description: We are searching for the best talent for an Executive Oncology Sales Specialist, CAR-T to be in the St. Louis, MO & Southern Illinois territory. About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine The Oncology Sales Specialist (OSS) is a Field Based role reporting to a District Manager. As the OSS you will: * Fulfill sales strategies by selling current and potential new oncology therapeutics. * Demonstrate a working knowledge of the products' clinical efficacy, provide clinical support/information as needed, and achieve their sales quota. * Conduct business analysis, actively prospect for new business within assigned territory, develop account strategies with District Manager to increase sales in the assigned territory (i.e., identifies key accounts, HCPs, develops specific plans for penetration). * Develop customer specific pre- and post-call plans that include objectives, probes and supporting materials. * Build customer dedication and identify and cultivate new relationships. Influence decision-makers by delivering a targeted sales message based on accurate clinical information, uses approved sales and marketing materials, and executes marketing strategies at the local level * Use resources appropriately while working successfully with JNJ Innovative Medicine team members and counterparts to share ideas and information to enhance business results. * Strong knowledge on assigned specialty products and their related markets in all areas relevant to internal and external customers: such as, clinical, technical and health economics. * Develop a complete understanding of the health care delivery system within each assigned account, including the physician hierarchy, key pharmacy personnel, clinical nursing staff, etc. * Maintain knowledge of reimbursement, short-and long-term sales potential relevant to percentage of patients treated, patient mix, Managed Care organizations and Specialty Pharmacies, and new protocols or new treatment modalities that impact business potential. * Attend and participate in all required sales meetings; complete all required training curriculum in a timely manner; achieve training standards; and organize and complete administrative responsibilities efficiently, including healthcare compliance, expense reporting, call reporting, and other assignments. Required Qualifications: * A minimum of a Bachelor's Degree * Oncology specialty sales experience AND/OR Major Hospital Account Sales Experience * Valid driver's license and the ability to travel as necessary, including overnights and/or weekends. * A minimum of two (2) years of direct selling experience in pharmaceutical or biologic/biotech with documented success in delivering sales results and achieving targets OR relevant clinical experience * Experience in hospital and large account sales, understand complex reimbursement and managed care dynamics with a documented history of successful sales performance in a competitive environment * Strong relationship building skills and the ability to identify key decision makers * Possess strong achievement motivation to meet and exceed goals * Residing in the geography or be willing to relocate to it. * Ability to effectively utilize virtual technology and a history of engaging customers in virtual face-to-face interactions Preferred Qualifications: * Hematology and/or rare disease specialty sales experience and an understanding of the Oncology market. * Previous product launch experience in a highly competitive environment * CAR-T experience Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Here's What You Can Expect * Application review: We'll carefully review your CV to see how your skills and experience align with the role. * Getting to know you: If there's a good match, you'll be invited to complete a short-recorded video interview, giving you the chance to share more about yourself. If successful, a recruiter will also reach out by phone to walk you through the process and answer any questions. * Interviews with the team: If you move forward, you'll meet with the hiring manager (and possibly others on the team) in one or two interview rounds, depending on the role. * Staying informed: We know waiting can be hard, so our recruitment team will keep you updated and make sure you know what to expect at each step. * Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. At the end of the process, we'll also invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPONA Required Skills: Preferred Skills: The anticipated base pay range for this position is : $111,000 to $178,250 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Director, HRIS and HR Operations role supports critical activities and initiatives within the Human Resources function to ensure alignment with business needs, efficient workflows and accurate data. This position is a strategic leadership role and a crucial link between HR and IT and other business units, using data and technology to drive operational effectiveness to support organizational goals. This role will report to the Chief Administration Officer (CAO) and is expected to both initiate and support operational and strategic initiatives in close partnership with the HR Leadership Team, key stakeholders across the HR department and internal business partners, as well as engagement with external consultants as required. Job Description Essential Functions Develop and execute the overall HR Operations and HRIS strategy, ensuring alignment with the organization's goals and objectives. Ensures data management for accuracy and integrity of employee data within HRIS. Ensure the security, integrity, privacy, and accuracy of all employee data through regular audits and robust governance protocols. Leads the HRIS team and HR Operations team in day-to-day administrative tasks. Drive continuous improvement initiatives to streamline administrative processes, eliminate redundancies, and enhance the overall employee experience. Generate and analyze HR metrics and reports to support strategic decision-making. Use data analytics to identify trends and opportunities for improvement. Enforce and maintain HR policies and procedures to ensure compliance with labor laws and data protection regulations. Develop and document efficient HR workflows and business processes to improve HR operations. Partner closely with HRBPs, Talent, Payroll, and IT to ensure seamless operational execution and an integrated HR technology environment Manage relationships with HR Technology vendors; oversee contract, renewals, SLA's and performance. Identify cross-functional stakeholders of projects and processes and proactively identify implications on their processes, policies, and work as a result of these projects Partner closely with HR leadership to ensure HR systems and operations evolve in support of business and people strategies. The above is intended to describe the general nature and level of work being performed by employees assigned to this role. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Minimum Requirements Education / Experience / Skills: Education: Bachelor's degree in HR or Information Systems Technology or related discipline required. Master's Preferred 10 years experience working with HRIS systems and 3 managing an HRIS team 3 years leadership experience in Human Resources Operations preferred 5 years experience in Human Resources Business Partnering role in the pharmaceutical industry preferred Experience with Workday HCM, Advanced Compensation, Benefits Security and Reporting modules Able to effectively partner with IT and non-technical customers to understand user needs and translate needs into technical process and configuration requirements. Strong leadership, management and team building skills to effectively lead cross functional project teams. Thorough understanding of and experience with the system development life cycle. Knowledge of both theoretical and practical aspects of project management. Strong problem solving/analytical skills with attention to detail and a high level of accuracy. Able to work in a dynamic organization by balancing multiple priorities. Able to work both independently and with cross-functional teams using good judgment. Proficient in Excel and managing data. Good verbal and written communication skills. Effective presentation skills for communicating the strategic story behind HR data. Expert at influencing without authority and navigating complex stakeholder environment and driving for results Organizational Relationship/Scope: This position works with and has visibility to business functional leaders and as well as collaborating with other HR members within the organization. Working Conditions: Normal office environment working conditions and the ability to travel about 10%. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: Join our St. Louis Cherokee facility at MilliporeSigma, a leading contract development and manufacturing organization (CDMO) and a recognized Center of Excellence for antibody-drug conjugate (ADC) manufacturing. We are seeking passionate and enthusiastic professionals to contribute to our innovative bioconjugate production, leveraging over 35 years of expertise in the field. As a vital part of our dedicated team, you will play a key role in delivering high-quality ADCs that improve the quality of life for patients suffering from cancer and other debilitating diseases. With our state-of-the-art technologies and commitment to excellence, you will ensure the highest standards of quality and compliance in our ADC manufacturing processes. As an Associate Production Scientist - Rotating Shift you will manufacture products according to established protocols under ICH Q7 pharmaceutical regulations, provide technical support to others and perform operations in support of the group and department. Job duties include: 12 hour rotating Day (6:00am - 6:30pm)/ Night (6:00pm - 6:30am) shifts with a 20% shift differential Evaluate products per established protocols, providing technical support and performing operations to meet departmental goals. Safely conduct routine processes and unit operations, including cleaning equipment and work areas, while ensuring quality expectations. Maintain required training and qualifications, train team members, and act as a technical consultant. Support facility functions by maintaining equipment, preparing reagents, restocking supplies, and managing waste disposal. Maintain accurate records and logbooks according to quality guidelines, communicating operational status and concerns to supervision. Collaborate with other departments, participate in quality audits and customer interactions, and perform procedures independently or in a team. Improve processes using scientific knowledge and principles, ensuring compliance with change control. Address unsafe conditions promptly and troubleshoot challenges related to biological processes and GMP compliance. Physical Attributes: Ability to lift to 50lbs. Ability to wear personal protective equipment, such as respirator or chemical protective clothing, for extended periods. Expected on-floor time: (70%) Who you are: Minimum Qualifications: Bachelor's Degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, etc.) OR Associate Degree in Chemistry, Biochemistry Biology or any other Life Science discipline 2+ years industry Production/Laboratory experience Preferred Qualifications: Experience with Antibody Drug Conjugates (ADCs), including knowledge of their formulation and manufacturing processes. Experience with Automated Tangential Flow and Automated Chromatography systems. Familiar with laboratory instruments and production equipment Familiarity with process techniques, unit operations, and safe chemical handling methods. Experience with Microsoft Office (Word, Outlook, Excel, etc.). Mechanical and troubleshooting skills. Knowledge of cGMP and ICH Regulatory and Quality standards. Knowledge of Operational Excellence. Clean room experience Ability to interact professionally in customer-facing meetings, including challenging discussions on process planning and process execution RSREMD Pay Range for this position: $25.00 - $45.00 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Manager, Information Systems is accountable for ensuring excellence in providing End User IT services to internal customers through service development, transition, and operations. The individual will ensure that service objectives and operational outcomes are achieved and will drive ongoing improvements in service operations performance. This role leads a team that is the face to our internal users and handles all direct IT Support for the user community. The support team will be comprised primarily of Internal resources with supplemental External Resources, which will require oversight to ensure all company policies and processes are followed. Additionally, guidance and direction will be set and communicated to site IT management regarding End User Support processes. Job Description Essential Functions Division Call Center and Service Depot Oversee the operations of the Division User Support Call center and Service Depot. Manage deskside support activities to ensure services are effective and efficient. Collaborate with the Director of Infrastructure and Operations in setting strategy for staffing utilizing employees and/or managed services. Identify and implement self-service solutions for the users. Conduct user focus groups to obtain productive feedback regarding IT services and performance for areas across the IT department. Create and conduct IT surveys to end users, interpret the results and work with Director of Infrastructure and Operations on department-wide improvements. IT Site Management Oversee Site IT and Managed Services for all corporate offices, distribution centers, and non-staffed plant locations to ensure IT services are delivered effectively, efficiently and to the business customer's expectations. Assure functions are current and operate within Service Level Agreements. Anticipate and identify issues that can inhibit service performance and develop and implement preventive and corrective actions. Manage external service provider(s) to assure SLA's are attained to ensure effective and efficient IT services are delivered. This includes fulfilling user requests, resolving service failures, fixing problems, as well as carrying out routine operational tasks. Ensure enhancements and projects follow IT change management guidelines to ensure all required information is available to support changes. Provide leadership, prioritization, and communications for critical incidents which impact services. Coordinate communication for end user impacting system changes and outages. Governance Assist Director of Infrastructure and Operations with M&A activities related to this functional area. Gather information, set Day 1 and Day 30 strategy. Develop project plan for people integration and site closures. Develop ongoing staffing plan and budgets for sites remaining open. Set Division Client Computing Standards Coordinate monthly standards discussion board. Communicate standards to division team. Enforce standards and monitor for compliance. Meet with vendors and keep abreast of roadmap changes to stay ahead of technology changes. Monitor end of life dates for software and hardware support, set new standards and drive compliance. Develop and maintain PC images and manage equipment/part inventory. Oversee client software licensing Annual validation of licenses. Negotiate upgrades with vendors as newer versions of software are introduced. Lead System Outage Action Team When a system outage occurs: Invoke outage procedure. Coordinate Communications to Users and IT Management. Hold Status Calls. Open outage resolution working call. Communication Manage IT Intranet/SharePoint sites to enhance the experience for our users and IT staff. Manage the ticketing tool to allow for ease of operation for users and staff, providing self-service opportunities and intuitive solutions. Escalate issues to the proper level of management within IT and the Business functions. Strategy Re-align IT services to the changing business needs by identifying and implementing improvements to IT services that deliver business outcomes. Drive service improvement plans that optimize the cost of IT Services while taking into account quality and risk factors. Monitor and continue to improve upon SLA's, KPI's, partner satisfaction, and service delivery outcomes. Financial Management: Optimize the cost of IT Services while taking into account quality and risk factors. With an understanding of TCO, operate department to determine the proper balance of internal resources, temporaries, and managed services. Directly manage User Support purchases including the annual laptop purchases. Indirect oversight for costs paid by the business for optional services, such as iPads, mobile phones, pc accessories. Technical: Provide desktop technology architecture, design, and support. Provide technical leadership for workstation imaging, management, and software deployment systems. Provide technical ownership of the ITSM software system. Minimum Requirements Education / Experience / Skills / Competencies: Bachelor's Degree in Management, Engineering, or Computer Science. 10+ years experience required in the following: Information Technology focused on End User Services. Developing, governing and managing both internal teams and third party service providers, which include staffing, budgeting and support process development. Managing an IT User Support Call Center working with both internal and managed service providers. Managing projects for global deployment of hardware and software. People management experience for individual contributors. Proven experience in delivering continuous process improvements through process change and new technology Experience working in ITILv3 service methodology. High-level knowledge of business functions, IT computing needs and the ability to convert that knowledge into top service levels to the user community. Proven competence to deliver IT End User services within the ITIL framework. Competent in ITIL strategy formulation and process design. Ability to measure and communicate key performance metrics for IT services and analyze data to discover opportunities for service improvement and market growth. Strong influencing and relationship building within all levels of IT and Business Stakeholders. Strong oral and written communications. English required. Organizational Relationship/Scope: This role reports to the Director, Infrastructure and Operations and leads a team. This individual interacts at all levels in the organization. Working Conditions: This role is located in an office environment. Periodic travel is required. This is a St. Louis based position. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary SUMMARY OF POSITION: The Sr. Director, Quality is responsible for a broad range of duties/functions that includes all Quality functions at the St. Louis Plant, and the Centers of Excellence for Microbiology, Elemental Impurities, and Validation, to support the Generics Business The Sr. Director, Quality is responsible for ensuring cGMP compliance and product quality at the Saint Louis, MO facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization. Job Description St Louis Plant Quality Responsible for and will develop, establish and maintain quality systems programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. May serve as liaison between the company and the various governmental agencies. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Establish and ensure compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; work with Research and Development during new product start-ups, and establish key checkpoints for new products and processes Centers of Excellence for Microbiology, Elemental Impurities, and Validation The Sr. Director is responsible for Centers of Excellence for Microbiology, Elemental Impurities, and Validation to support the Generics Business. Will develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establishes and maintains positive and mutually rewarding relationships with internal and external customers of the department. The Sr. Director will be also responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with company policies and procedures. ESSENTIAL FUNCTIONS: St Louis Plant Quality Departments Manages all aspects of plant Quality Systems including, CAPA, Supplier Quality, Change Control, in-process Quality Assurance, Quality Control, complaint management and validation functions. Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies. Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant. Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured at the St. Louis Plant facility. These decisions must be made within the requirements of cGMPs and applicable regulatory/industry guidance documents. Manage approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents. Ensure the evaluation of batch records and that all necessary testing is carried out. Approve specifications, sampling instructions, test methods and other QC procedures. Ensure the authorization of all controlled documents, including records retention. Ensure the monitoring and control of the manufacturing and Quality Control environments. Ensure compliance with cGMP standards. Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance both for Corporate and for applicable regulatory agencies. Coach and develop the team to High Performance while fostering a culture of team ownership. Ensure team compliance with all policies, procedures and site/company regulations. Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member's performance management. Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion. Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward. Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems. Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input. Ensure proper maintenance and cleanliness of the department, premises and equipment. Measure and communicate team's progress against individual, team and site goals and Key Performance Indicators (KPI's). Lead and/or support investigations. Author, approve and/review area quality and safety exceptions and investigation reports. Ensure on-time completion of all corrective action items assigned to area. Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility. Identify opportunities to reduce costs, reduce risk and improve service. Centers of Excellence for Microbiology, Elemental Impurities, and Validation Develop policy, create systems, develop strategies and minimize costs while striving for excellence in customer service. Establish and maintain positive and mutually rewarding relationships with internal and external customers of the department. T Responsible for oversight and management of the training department to include all NEO, CBT and OJT systems in alignment with Mallickrodt policies and procedures. General Budget creation and management for Quality, and Traing Departments (>$15MM). Defines requirements of department personnel and works with Human Resources to hire such personnel. Acts as subject matter expert and lead with internal and external regulatory inspections and audits of manufacturing sites in the area of Quality Systems, and Training. Interfaces with FDA and regulatory agencies outsite the US for events that include but are not limited to: manufacturing site inspections, Field Actions, and Recalls. Perform other duties as assigned. MINIMUM REQUIREMENTS: Education: Bachelor's degree in chemistry, microbiology or similar life sciences or technical field such as engineering, mathematics, etc. Experience: Minimum of 15 years of pharmacuetical industry experience in a Quality Assurance and/or Regulatory Affairs function including experience in manufacturing and control of bulk drug substances, and solid dosage form drug products. Minimum 5 years managerial experience in a pharmaceutial quality/regulatory affairs environment. Preferred Skills/Qualifications: Previous experience serving as a pharmaceutical manufacturing site leader of a significant quality function (Total Plant population >500 persons, Quality Function >100 persons). Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports. Knowledge of FDA and International regulations and guidances in the area of Quality Systems for pharmaceutical products and medical devices. Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host. Strong patient and customer focus. Skills/Competencies: Strong writing skills to effectively communicate technical/clinical information to others. Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies. Superior verbal communication skills including impeccable telephone etiquette. Scientific literature searching and evaluation skills. ORGANIZATIONAL RELATIONSHIPS/SCOPE: This position reports to the Head of Quality. This position will have frequent communication and working relationships with USA manufacturing plant management and QA/RA personnel. Contact with regulatory authorities, state, federal and international is common. WORKING CONDITIONS: This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn Approximately 10 to 15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off-site business meetings and professiona training seminars and conference. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The Pharmaceutical Technician executes all production and packaging processes while adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply at the Fenton Manufacturing Plant. Under the supervision of the Manufacturing Supervisor, technicians will weigh raw materials, blend raw materials, process active compounds into final dosage form and package final product for shipment. The technician is expected to fully participate in both departmental projects and any quality working teams. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Operates equipment required in the manufacture of pharmaceutical products including, sifters, blenders, tablet press, fluid bed, granulation, encapsulation, pan coaters and packaging + Monitor the production process, make periodic checks and adjust equipment or work practices to maximize production efficiency, yields, quality and safety. + Accurately reports production and ensures reports are completed as required + Prepares and submits samples to Quality Control Laboratory. + Reviews, writes and update SOP's + Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure + Perform basic maintenance, trouble shooting, minor repairs, machine setup and breakdown + Perform inventory functions including but not limited to WIP, Cycle Counts, receiving/shipping functions, etc. + Follows all EHS rules and regulations. + Take proactive steps to ensure a safe work environment and ensure safety issues are corrected. + Complies with all site security requirements. + Performs lock-out/tag-out procedures according to SOPs. + Follows safe working practices in the execution of their assigned duties. + Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies. + Ensures that processes comply with all cGMP regulations in regards to process and cleaning validations. + Participates in investigations and corrective actions + Participate and provide direction in process improvements, reviews corrective actions to provide input. + Troubleshoot equipment, processes and production problems with appropriate personnel. + Perform other duties as assigned. **MINIMUM REQUIREMENTS** **:** _Education:_ + High School diploma or GED. _Experience:_ + Minimum of 1-5 years' experience working in pharmaceutical industry. Solid oral dose production experience is preferred. _Preferred Skills/Qualifications:_ + Excellent communication skills, both written and oral + Strong attention to details + Mechanical knowledge of production equipment + Ability to work in and promote a team environment. + Knowledge of cGMP regulations _Other Skills:_ + Strong working knowledge of Microsoft Office products **RELATIONSHIPS WITH OTHERS:** The Pharmaceutical Technician supports the pharmaceutical manufacturing process and may be assigned a general plant support role. This position interacts with production supervisor, production technicians, production managers, maintenance, engineering, purchasing, safety and training. **WORKING CONDITIONS:** Works majority of time on the production floor in manufacturing with some office type environment work. Working hours are regular daytime hours but are subject to change. The time spent on the production floor may be for extended periods of time within a manufacturing facility. Must be willing and able to wear PPE including steel-toed shoes, safety glasses, earplugs, and other devices or equipment that may be required. Heavy physical demand requires frequent moving, pushing, pulling, rolling and dumping of up to 100 kg and manual lifting of up to 25 kg. **DISCLAIMER:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.