Daiichi Sankyo jobs

Nature and Scope This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Manufacturing Process. The Manufacturing Process includes loading of glass vials, stoppers, caps and seals into manufacturing machinery, unloading of finished product from the manufacturing machinery and the set-up/tear-down and line clearances of the manufacturing equipment. The manufacturing technology utilized at PharmaForce Inc. - New Albany includes HMI-PLC/SCADA controlled Isolation Barrier Aseptic Filling, Autoclave Sterilization, VHP Sterilization, CIP Sanitization, SIP Sterilization and Lyophilization. The Team Member will be proficient in all activities associated with the manufacturing process and be able to work with minimal supervision. The Team Member will receive direction, training and mentorship from the Senior Filling Operators. The Team Member will, with assistance from a Senior Team Member/s, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Team Member will be able to select parameters requiring Senior Team Member Approval for some manufacturing technologies using the HMI-PLC/SCADA control/data systems. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Gathers, stages and returns production materials in support of manufacturing activities. * Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing. * Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities. * Staffs various stations in support of container washing, filling, stoppering, and capping. Will offload finished product. * Ensure that only approved documentation and procedures are utilized. * Oversee production supply, materials and equipment gathering, staging and sampling activities required to support manufacturing. * Oversees and performs QC sampling activities required to support manufacturing. * Ability to perform minor machine diagnostics and repairs as required. * Attends all training programs as required by Company SOPs, procedures and policies. * Perform any other tasks/duties as assigned by management. * We all must embrace the QUALITY culture. Qualifications and Requirements * High School Diploma or GED equivalent preferred. Technical degree and/or some college in a relevant field is a plus. * Minimum one year as a Filling Operator I, having performed at a satisfactory level or similar work experience in a related field preferred. * Ability to perform basic mathematical calculations. * Possesses mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment. * Ability to take feedback constructively and function in a team oriented work environment. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Ability to work overtime as needed. Physical Environment and Physical Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. * Employee must be able to occasionally lift and/or move up to 50 pounds. * Ability to meet and maintain cleanroom gowning requirements. * Ability to meet and maintain respirator fit-testing requirements. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The Facilities Supervisor position involves supervising repairs and maintenance activities to keep the facility equipment (i.e. office, security, comfort cooling, and general equipment) operational and in compliance with Good Manufacturing Practices. This position will assist the Facilities Manager in managing and directing daily tasks within the department for all Ohio sites. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. A. Perform and Supervise Preventive Maintenance (PM) Tasks * Identify and track facility PM tasks to completion within the CMMS system. * Tracking to include identifying new needs, opening work orders, and executing them. * Follow written PM procedures, accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, Current Good Manufacturing Practices (cGMP), and health and safety requirements. * Coordinate access to equipment, working around customers' needs. * Lead, schedule, and oversee facilities technicians during the absence of the Facility Manager. * Assign, review, and approve department work orders in BMRAM CMMS to ensure timely completion of work. * Coordinate daily priorities with the Facility Manager, Manufacturing, Quality, EHS teams, and other departments. * Strong communication and leadership skills to manage technicians, vendors, and cross-functional teams. B. Execute Repairs * Respond to customer requests and/or alarm conditions. * Assess equipment failures/breakdowns, systematically identify problems, and restore to operation. * Accurately document repair activities. C. Support Facility Operations * Assist with onboarding new hires. * Complete facility maintenance projects (painting, light carpentry, drywall, lighting, etc) * Coordinate with Site Service Providers (security, fire protection, landscaping, snow removal, pest control, etc.). * Troubleshoot issues that arise. * Assist and supervise facilities technicians. D. Contractor Support * Schedule and coordinate contractors with customers and building management. * Support contractors performing tasks within buildings. * Ensure that contractors follow company safety and cGMP standards. * Oversee technical quality of work performed. E. Lead Small Projects * Identify potential facilities projects and recommend to Facility Manager. * Coordinate necessary parts and equipment needed for the project, including creating ePRFs and CARs. * Manage small projects to completion. * Perform any other tasks/duties as assigned by management. F. Documentation and Reporting * Maintain accurate and completed repair logs and change control documentation. * Review and approve technician work orders for accuracy and GMP compliance. * Generate reports on recurring issues and trends. * Create new requisition on the PO system to generate POs and approve for payment. * Participate in deviation investigation and provide reports as required. * Support facility manager in generating reports for audits. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Required * High School Diploma or GED required or a minimum of 5 years of experience in maintenance in a manufacturing or lab environment. Bachelor's degree in a technical field preferred. * 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group. * Basic knowledge of electrical systems and electronics. * Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters. * Working knowledge of Microsoft Office Applications, including Microsoft Word, and Excel. * Ability to clearly understand, describe and neatly document technical issues and work performed. * Hands-on ability to isolate problems and identify root cause of issues. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Preferred * Experience working in a Pharmaceutical or similar regulated industry. * Working understanding of cGMP, GDP, and FDA requirements as they apply to maintaining a plus. * Basic understanding of engineering principles as they apply to facility equipment. * Basic knowledge of Building Automation Systems. * Experience in troubleshooting mechanical and electrical control problems. * Working knowledge of OSHA safe work practices. * Ability to read P&IDs, electrical drawings, and blueprints. * Comfortable working in a production environment with multiple priorities. * Basic knowledge of CMMS (computerized maintenance management systems). * Flexibility to work multiple shifts and off hours during shutdown, plus some overtime. * Basic knowledge of Siemens BAS system. Physical Environment and Requirements * Employee must be able to occasionally lift and/or move up to 50 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope This position is the day-to-day lead of the Document Control (DC) Group. The DC Group is responsible for controlled documents associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The DC Group provides support to other departments as needed and is critical in maintaining production schedules and meeting Company Goals. The DC Group participates in the administrative functions of the Change Control Process. This includes all aspects of the document lifecycle such as: editing, reviewing for conformance to formatting standards, tracking, and issuing as per applicable SOPs. The DC Supervisor supervises the day-to-day activities of the DC Group and ensures appropriate management of the DC System (Veeva EDMS). The DC Supervisor works under the direct supervision of in the Document Control and Change Control Manager in Quality Assurance. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Supervision of the revision and maintenance of controlled documents including Standard Operating Procedures, specifications, protocols, and other miscellaneous controlled documents in Veeva. * Supervision of the issuance of batch records for manufacturing/production. * Supervision of the Central Archive and responsible for providing guidance for document filing and destruction within the Central Archive. * Facilitation of personnel accountability for both the document and the document control process including: reviewing for conformance to formatting standards, editing, proofreading, and tracking of proposed changes. Auditing of documents, DCRs, DCCs in Veeva EDMS. * Responsible for document metrics which are reported to Senior Management. * Provide support for the Regulatory Affairs Group, regulatory inspections, and internal/external audits. * Ensure all work output of the Document Control Group is performed and documented in accordance with cGMP requirements and existing company policies and procedures. * Responsible for updating SOPs related to the document control process. * Provide effective leadership for 4 employees including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Associate's or Bachelor's degree in Life Sciences or related field is preferred or equivalent work experience in the management of controlled documentation. * 3-5 years experience in the Document Control or Document Management function required. * 2 years experience in a supervisory role preferred. * Experience in an FDA-regulated environment is required. * Experience with electronic document management systems is preferred. * Intermediate skills in Microsoft Office, Word, and Excel are required; Visio and Access are preferred. * Excellent organizational, interpersonal, and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team oriented work environment Physical Environment and Requirements * Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The Environmental Monitoring Team is responsible for the activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The Environmental Monitoring Team works in concert with and assists the manufacturing department, and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. The EMT I position is primarily responsible for performing environmental monitoring activities including water collection, air, surface and personnel monitoring within the sterile manufacturing facility. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Plan daily workload to meet requirements. * Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas. * Conduct water sampling throughout facility. * Record results and report deviation from specifications. * Communicate any discrepancies or deviations to supervision/management upon discovery. * Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements. * Inputs data into database and conduct trend analysis. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associate Degree in microbiology, biology or related scientific field preferred. * Academic or industry work experience in laboratory setting or manufacturing with focus on microbiology preferred. * Knowledge of aseptic technique preferred. * Must be able to maintain Class 100 Certification for EM support. * Ability to work independently with minimal supervision. * Organization and attention to detail. * Excellent communication skills (Oral and Written). * Working knowledge of MS-Office software and PC Skills Required. * Good work ethic and highly motivated. * Ability to work in a fast paced environment. * Ability to work in a team oriented environment. * Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. * Employee must be able to occasionally lift and/or move up to 25 pounds. * Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope This position is a member of the Quality Assurance team. This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes. * Performs sampling of components. * Conduct verifications and checks through accurate material inspections. * Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system * Management of BPCS for verification and disposition of materials * Maintain retain samples for all primary and secondary components and labeling * Performance of DAF (Destruction Approval) process for rejected materials * Use of Trackwise and Veeva for change controls, as needed * Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements * Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. * Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation. * Support generation of logbooks and sheets/labels as required. * Basic knowledge of cGMPs and supporting regulatory documents * Perform room, area and equipment clearances that may be necessary for this job function. * Able to perform tasks with minimal error rate. * Assist other Quality Assurance Operations Associates, as needed. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. * At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred. * Must be able to do work independently. * Experience in QA working in a cGMP manufacturing environment (preferred) * Working knowledge and understanding of quality assurance principles and familiarity with QA programs * Strong analytical skills, attention to detail and adherence to procedures. * Intermediate skills in Microsoft Word and Excel are required. * Excellent organizational, interpersonal and communication skills (written and oral) required. * Ability to take feedback constructively and function in a team-oriented work environment. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. * Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Description Performs responsibilities in generating sales, market share and profitability results for assigned territory with appropriate direction. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.Duties & Responsibilities Meets sales objectives and supports attainment of district and regional/ business unit performance objectives Development of market, customer, and industry knowledge along with further development of technical product knowledge is imperative. Effective utilization and management of internal and external resources is expected. Perform customer/consumer training meetings and support convention and professional association business building opportunities. Maintains and utilizes expert product knowledge and highly effective selling skills in order to influence customers to support the use of BIAH promoted products. Executes brand strategies to ensure a consistent company sales and marketing message. Uses appropriate BIAH Sales Training techniques to facilitate the sale. Utilizes CRM tools to create pre-call plans. Keeps current territory records concerning activities; communicates timely, accurately and meaningfully with Management. Utilizes CRM tool and supporting analysis to plan activity, report, monitor samples and maintain customer records. Analyzes territory information to optimize customer calls and create annual business plan for execution. Monitors market conditions for changes that impact our business. Completes objectives including achieving sales plan while operating within specified expense budget. Successfully completes all sales training requirements. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. Requirements Sales Representative: Bachelor's degree from an accredited institution required. Minimum of two to five (2-5) years of relevant field sales experience in a competitive selling environment required, or a minimum of two (2) years as a degreed, licensed and practicing Doctor of Veterinary Medicine in a clinic or animal health organization. Animal health or related industry experience preferred Ability to work with general supervision General knowledge of industry practices, techniques, and standards Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Senior Sales Representative: Bachelor's degree from an accredited institution required. Minimum of five-plus (5+) years of relevant field sales experience in a competitive selling environment required Animal health or related industry experience preferred Ability to work with general direction Complete understanding and application of principles, concepts, practices and standards Full knowledge of industry practices Experience presenting to various size audiences Must demonstrate an aptitude and desire to sell and gain market share Ability to learn technical product knowledge quickly Key competencies include: interpersonal skills, drive, resilience, persuasive skills, teamwork, organization skills and strong verbal and written communication skills PC skills and the ability to use mobile applications Ability to travel (may include overnight travel) Should reside in territory geography or be willing to relocate Valid driver's license and an acceptable driving record to drive a company leased vehicle or authorized rental vehicle Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older

Nature and Scope Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Conduct laboratory experiments with minimal supervision to support formulation and process development of injectables Execute laboratory studies for characterization, stability studies per ICH guidelines, component selection and scale-up activities Execute and support the formulation team on experiments to support the selection of process parameters and development of manufacturing process. Prepare formulations to support analytical method development. Draft protocols/reports on the formulation development experiments and deliver data presentations. Assist in the general operation of the R & D formulation laboratory including maintenance of Standard Operating Procedures (SOP's) and equipment validation or maintenance. Maintain clean and safe work environment in the laboratory. Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. B.S. in Pharmaceutical Science, Chemistry, Chemical Engineering or equivalent required. 2-3 years, or for M.S. 0-2 year, of experience in drug product development required. Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl Fisher titrator is a plus. Excellent organizational, interpersonal and communication skills required. Proficiency in Microsoft Office Word and Excel is required. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Position requires working in the laboratory as well as sitting. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, appropriate manufacturing area and equipment records are neat and accurate and safe, effective, and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Production Supervisor will be able to oversee all aspects of the Manufacturing Process. The Manufacturing Process includes component prep, aseptic cleaning, compounding, filtration, and filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Production Supervisor will be able to perform, oversee and provide signatory approval for all activities associated with the manufacturing process. The Production Supervisor will be able to provide direction, training and mentorship to all junior team members as needed. The Production Supervisor will be the responsible person for the proper use of batch documentation. The Production Supervisor will be able to troubleshoot most of the manufacturing process and equipment and where necessary make adjustments and minor repairs during setup and during operations. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Supervises manufacturing activities as defined by established operating procedures for multiple products on a daily and weekly basis by delegating resources as well as participating in the process. Responsible for the training and mentoring in all facets of the manufacturing process. Responsible for reviewing executed batch records and logbooks prior to submitting for final production review. Responsible for reallocation of personnel based on production needs. Responsible for creating weekly activity schedules to ensure production needs are met. Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules. Ensures only approved materials and equipment are utilized at all times. Ensures that personnel do not perform tasks for which they do not have accurate and approved training records. Ensures that only approved documentation and procedures are utilized at all times. Attends all training programs as required by Company SOPs, procedures and policies. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Bachelor's in Pharmaceutical Science, Chemistry, [Micro] Biology, Engineering, or a related field is preferred. 1 to 3-years of leadership experience required and/or has demonstrated the ability to lead, coach or mentor a team or group. Experience in manufacturing, the pharmaceutical industry, or with GMP/FDA regulations is a plus. Chemical handling, mathematical aptitude, and the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment is preferred. Experience writing, reviewing, and executing standard operating procedures. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 50 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area, equipment and batch records are neat and accurate and that safe, effective, and professional behavior is always displayed. The Component prep, Sanitization and Sterilization Technician I will be able to participate in all aspects of the component and equipment Prep Process including the sanitization of controlled manufacturing areas and post terminal sterilization. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile pharmaceuticals. The Sanitization of controlled areas plays critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Team Member will assist with all activities associated with the component prep, sanitization and sterilization process under the direct supervision of Senior Manufacturing Team Members. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company Goals. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor. Performs a variety of production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization. Complete production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements. Ensure strict adherence to and compliance with SOP's and protocols. Ensure all work is performed and documented in accordance with existing company policies, procedures (SOP's), Current Good Manufacturing Practices (cGMPs), and health and safety requirements. Provides feedback to supervisor and peers about cycle status, equipment condition, and other issues that would affect the production schedule or relate to continuous improvement. Cleaning of all manufacturing areas Gain the Knowledge of batch records and processes cGMP Compliance Execution of tasks and working in a clean room environment Preparation of solutions and dilutions Material handling using pallet jacks and power industrial trucks Tray Transfer De-boxing Autoclave daily and weekly test including system checks Preparation of materials, equipment, and components for autoclaving Generation of component autoclave labels using work templates Understanding load patterns and cycle parameters for steam and dry heat sterilizers Loading and unloading sterilizers Requisitioning and receiving equipment and area logbooks Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED required. One year working experience in a manufacturing production environment preferred. Ability to perform repetitive lifting, cleaning, and stacking activities. Mechanical aptitude preferred. Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages. Strong attention to detail or organization skills. Excellent interpersonal and communication skills (oral and written). Demonstrated success working in a team environment. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Employee must be able to occasionally lift and/or American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope A technical position involving instrument calibrations and operation intended to keep the facility instrumentation and equipment (i.e., process, utility, and general equipment) within compliance of cGMPs. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform Preventative Maintenance Tasks * Follow written PM procedures. * Accurately complete PM paperwork, including work orders and logbooks in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements. * Perform PM of all types of plant equipment including coordinating access to equipment working around customer's needs. B. Execute Repairs * Respond to customer requests and/or alarm conditions. * Assess instrument failures/breakdowns, systematically identify problems, and restore to operation. * Accurately document repair activities. * Support Quality Assurance investigations of failures/breakdowns. C. Operate Plant Utilities * Monitor site (steam, electric, chilled water, compressed air, etc.) and clean (WFI, clean steam, etc.) utility operating parameters. * Respond to out-of-range conditions or trends. * Troubleshoot issues that arise. D. Contractor Support * Support contractors performing tasks within building. * Ensure that contractor employees follow company safety and cGMP standards. * Oversee technical quality of work performed. E. Lead Small Projects * Manage small ( * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * H.S. diploma or GED required. Trade School/certification in a technical discipline preferred. * Minimum 1 year of experience in maintenance in a manufacturing or lab environment preferred. * Experience working in a Pharmaceutical or similar regulated industry preferred. * Must be comfortable in the use of Microsoft Office Applications, including Microsoft Word, and Excel. * Basic knowledge of CMMS (computerized maintenance management) systems. * Basic knowledge of electrical systems and electronics. * Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters. * Basic understanding of engineering principles as they apply to facility and production equipment. * Basic knowledge of instrumentation field wiring and to PLCs (Loop Powered and self-powered instruments, RTDs, thermocouples, etc.). * Some background in troubleshooting mechanical and electrical control problems with Allen Bradley or Siemens PLC experience. * Detail oriented. * Hands-on ability to isolate problems and identify root cause of issues. * Ability to focus on problem at hand in systematic manner. * Able to troubleshoot systems and instruments. * Ability to clearly describe technical issues. * Ability to clearly and neatly document work performed. * Ability to follow PM procedures that clearly define required tasks. * Working knowledge of OSHA safe work practices. * Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus. * Ability to read P&ID's, electrical drawings, and blueprints. * Ability to work independently with some supervision. * Good organizational, interpersonal and communication skills (oral and written). * Comfortable working in production environment with multiple priorities. * Able to work and interconnect effectively as a team member. * Able to juggle multiple tasks with supervisory guidance. * Comfortable working in culture of performance that emphasizes responsiveness. * Works to ensure that customer timelines are understood and met. * Flexibility to work multiple shifts and off hours during shutdown plus some overtime. * This position is part of a multi-shift operation and may require assignment to a regular off shift and/or weekends schedule. * 9TMust be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. * Employee must be able to occasionally lift and/or move up to 50 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope As part of a team of Analytical Chemists, this position is responsible for performing the analytical activities necessary to support finished product and raw material groups. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs. Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products. Assist in the identification of synthetic impurities and potential degradation products utilizing various chromatographic and spectroscopic techniques. Perform analytical analysis using HPLC, GC, UV/VIS and FTIR. Create and maintain accurate lab record documentation. Perform routine maintenance and calibration of laboratory instrumentation. Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, health and safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. B.S. in Chemistry, Pharmaceutical Science or related field required. Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers. Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The Senior Manager of Training is responsible for leading and overseeing all training and development initiatives for the company. The Senior Training Manager will be responsible for leading and developing the training department, designing, implementing, and evaluating comprehensive training programs to enhance employee skills, knowledge, and performance, ensuring compliance with all industry regulations and company standards. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Develop and implement training strategies and programs aligned with the company's goals and objectives. * Conduct needs assessments to identify training gaps and develop appropriate training solutions. * Design and deliver engaging and effective training programs using a variety of methods, including classroom instruction, e-learning, on-the-job training, and workshops. * Oversee the Learning Management System (LMS) and integrated functionalities in related platforms ensuring seamless operation and alignment with training objectives. * Evaluate the effectiveness of training programs through assessments, surveys, and performance data. * Develop and maintain training programs to ensure full compliance with regulatory requirements, quality standards, and industry guidelines for pharmaceutical manufacturing. * Manage the training budget and ensure cost-effective delivery of training programs. * Lead, develop and mentor the Training Department team. * Proactively seek and secure learning grant opportunities to sustain a pipeline of new, innovative programs. Collaborate with department heads and subject matter experts to develop training content and identify development needs. * Stay current with industry trends and best practices in training and development. * Manage training department functions ensuring compliance throughout all processes and aligning strategic planning with organizational goals. * Participate in and lead global culture initiatives overseeing the successful launch of global expectations, employee resource groups and other strategic organizational objectives. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelor's degree in Human Resources or a related field required. * Minimum of 10 years' experience in training and development, with at least 5 years in a manufacturing environment required. * Minimum 5 years' experience of leading a training department along with developing and managing a diverse team required. * Certification in training and development (e.g., CPTD) is a plus. * Knowledge of regulatory guidelines governing pharmaceutical manufacturing preferred. * Proven experience in designing and delivering training programs using various methods. * Excellent communication, presentation, and interpersonal skills. * Strong project management and organizational skills. * Proficiency in using a learning management systems (LMS) and other training technologies. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The Validation Technician is responsible for validation equipment preparation, protocol execution and final report generation as directed. This position will be primarily responsible for the execution of protocols associated with the installation, operation qualification and requalification of equipment, and utilities used in the analysis and manufacture of sterile pharmaceutical drug products. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Assist in the development of validation protocols (IQ, OQ, PQ) and coordinate protocol approval. Plan and coordinate validation project activities including protocol execution and work schedules. Perform the execution of protocols and produce report summaries. Analyze validation test data to ensure the data meets validation criteria. Validation technicians apply validation methodologies to complete tasks, perform installation and operational activities, produce representative summary reports, and may work under the direction of supervisor/lead or independently depending upon experience with activities. Assist Validation and QA to track and coordinate requalification events. Provide assistance and input to address validation deviations. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED Equivalent Required. Associate's or Bachelor's Degree in Life Science, Engineering or a related field preferred. Minimum 1 year of experience in a related field/experience preferred. Strong knowledge of MS-Office software and PC Skills required. Good technical writing skills. Excellent written and verbal communication, problem-solving, planning and organization skills. Ability to work independently with minimum supervision, including managing priorities that are in alignment with departmental and site directives. Experience in executing thermal mapping protocols is preferred. Validation specific equipment expertise preferred: Kaye Validator 2000, Ellab (Val Suite Software), ValGenesis. Ability to work overtime as needed; specifically off hours and weekends. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The QC Environmental Monitoring Supervisor works with Environmental Monitoring (EM) Technicians in the activities associated with the manufacture of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The Supervisor will liaise with Production/Compounding Supervisor and Production/Filling Supervisor to ensure the necessary support required by those areas is provided. The Supervisor will oversee the environmental monitoring program and will provide training, guidance, and support to EM Technicians. The Supervisor will coordinate day-to-day activities and the scheduling of EM Technicians and provide input and assistance to other departments as needed. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under the direction of the Microbiology Manager, supervise the environmental monitoring program and technicians. Responsible for completing and maintaining gown qualification and gown training other staff members (Hilliard). Provide technical and administrative support for all activities related to environmental monitoring, and documentation. Coordinates work projects with the Microbiology Manager to appropriately schedule EM workload to meet department/site requirements. Schedule employees with respect to workload to improve efficiency. As required assist EM technicians in sampling and other environmental monitoring responsibilities. Reviews SOP's as necessary, recommend changes, update and initiate change controls as needed. Review EM paperwork accuracy and completeness and submit to laboratory with plates for incubation in timely fashion. Issue and perform internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results, in a timely manner Perform and maintain environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager. Ensure and check the media and material inventory required for the environmental monitoring program and order supplies as necessary. Closely interact with and support manufacturing and quality personnel in all aspects of environmental monitoring. Assist Manager with timely completion of quarterly and other periodic projects and reports. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School Diploma or GED equivalent required. Bachelor's Degree in microbiology, biology or Environmental Sciences or related scientific field preferred. 2 -3 years experience in a pharmaceutical aseptic processing environment, production QA, aseptic testing, medical device or food industry in area of microbiology or a combination required. Previous experience working in environmental monitoring/sampling, writing EM protocols and EM investigations, water sampling, performing PQ of new EM and water systems, and gown qualification program required. Experience with instruments like Met One, APC, air ideal, MAS 100, MAS 100 CG, Lighthouse System, or PMS system is required. Minimum 1-2 years of lead or supervisory experience preferred. Must flexible with working hours dependable and able to work overtime as needed, according to the production schedule. Demonstrate responsibility and accountability working within in a multi-disciplinary team environment. Ability to mentor subordinates. Excellent computer skills and proficient in Microsoft Word, Excel, and Outlook. Excellent communications skills both verbal and written. Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment. Sense of ownership and ability to take responsibility Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives! Accountabilities • Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Execute call plans and Brand Strategy by translating data to actionable insights. • Adapt to and demonstrate a thorough understanding of AZ Selling Model. • Analyze data and trends to build insightful and actionable business plans for your assigned sales territory. • Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands. • Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions. • Open to receiving guidance and seek insights for growth and development. Essential Skills/Experience • Bachelor's Degree • 0 - 2+ years of demonstrated Sales or B2B, or Commercial experience • A valid driver's license and safe driving record Essential Skills and Capabilities • Customer Focus: Strong customer relationship management skills with the ability to understand and address customer needs. • Business Acumen: Ability to analyze and interpret complex data to develop strategic sales plans. • Technical Aptitude: Proficiency in using digital tools and platforms to engage with healthcare professionals. • Adaptability: Flexibility and adaptability to changing market conditions and customer needs. • Collaborative: Ability to work effectively in a team environment and collaborate with cross-functional teams. Desirable Skills/Experience • Experience selling to general practitioners (GPs) and primary care centers • In-depth understanding of the healthcare industry and primary care operations At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our team thrives on energy and pace, constantly thinking big to answer new challenges. We lead Commercial to provide solutions that make a difference, improving our patients' experience and health outcomes. Join us in making a difference in patients' lives - apply today! Date Posted 18-Nov-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Cardiovascular Renal (CVR) Medical Science Liaison, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The BioPharmaceuticals Business Unit (BBU) creates and executes meaningful therapeutic area and product strategies that are focused on addressing the unmet needs of patients around the world. We are committed to changing the course of medicine and bringing innovative therapies to enhance the quality of life for our patients. The BBU integrates commercial, market access, medical, digital, and corporate functions to drive scientific development and commercial excellence in the core areas of respiratory, cardiovascular, renal and diabetes disease. As a CVRM Medical Science Liaison you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. You will be a critical part of the evolution of how AstraZeneca is impacting practice change through innovative technological advances to include targeting high disease burden and low guideline based medical care. Our mission is to partner with health care practitioners to reduce acute episodes, disease complications, hospital admissions and premature death. Through science and innovation, growth and leadership with an emphasis on people and sustainability, we truly put patients first! Typical Accountabilities: The CardioRenal Medical Science Liaison is a field-based professional with scientific, clinical and therapeutic area expertise responsible for providing medical and scientific support for Cardiorenal marketed products, new indications for current products, and compounds in development. In this role, you will engage in scientific exchange with targeted Key Opinion Leaders (KOLs), Key Decision Makers (KDMs), and Healthcare Professionals (HCPs) consistent with the Medical Affairs organization's and Therapeutic Brand Teams' objectives. Additionally, you will identify and engage key customers with scientific expertise and business knowledge of AstraZeneca marketed products and compounds in development. This includes developing peer-level relationships with Key Decision Makers (KDMs), HCPs and researchers consistent with Scientific and Medical Affairs strategy and objectives along with identifying pre-clinical, clinical and post-marketing study investigators in alignment with the goals of Clinical Development activities and Therapeutic Brand Teams initiatives. As a Cardiorenal Medical Science Liaison, you will uncover barriers to optimal disease management, identify areas of greatest opportunity and readiness for improving patient outcomes, provide actionable information that enhances the value and appropriate use of company's products to internal stakeholders; respond to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of the company's products and services and deliver appropriate clinical and scientific information that clinically differentiates the company's products. Additional accountabilities include adhering to internal standard processes and complying with regulatory and compliance requirements along with sustaining expertise in disease state management, emerging therapies and the competitive landscape; providing clinical support and delivering data presentations regionally and nationally; demonstrating project leadership and management in and across the field medical team and therapeutic area; training and mentoring within therapeutic area, providing performance guidelines and coaching. Essential Requirements: • Advanced Clinical/Science Degree required (e.g. MD, PharmD, PhD, NP, PA-C, etc. - BSN with extensive clinical experience may be considered) • Thorough understanding of healthcare system landscape • Established networks and clinical experience within Therapeutic Area (TA) focus • Experience in pharmaceutical industry • Demonstrated expertise in discussing scientific content and context to multiple audiences • Excellent oral and written communication and interpersonal skills • Strong leadership capabilities • Excellent project management ability • Thorough knowledge of regulatory environment • Ability to travel 50-70% (percentage varies with geography) Desirable Requirements: • Established experience delivering quality improvement initiatives • 2+ years' experience as a Medical Science Liaison in the pharmaceutical industry • Established track record of basic or clinical research The annual base pay for this position ranges from US $147,363.20 & $233,698 Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 02-Dec-2025 Closing Date 09-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

The Cardiovascular-Renal Sales Consultant is responsible for partnering in developing and implementing a plan for brand sales growth of BIPI and co-promoted cardio-renal-metabolic (CRM) products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Cardiovascular-Renal Sales Consultant will conduct their business with key targeted healthcare providers (Cardiology specialists/Nephrology specialists/Advanced Practice Clinicians and Allied Healthcare Professionals). The consultant will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals, heart failure clinics, managed health care facilities, and integrated delivery networks, etc. utilizing in-person and/or digital/virtual platforms. The CR consultant is also responsible for generating advocacy for BI products with Key Decision Makers in the hospital accounts they are responsible for. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Leverages knowledge of cardiology, nephrology, diabetes, and the marketplace to anticipate and effectively manage business opportunities and challenges. Demonstrates knowledge of the disease state, key drivers, influencers, and prescribing patterns in territory. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Works effectively with all customer-facing roles (i.e.. account teams, medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates knowledge of BIPI cardio-renal-metabolic (CRM) products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Delivers high level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. As a trusted CR Consultant, encourages and receives requests from customers for technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with customers. Drives appropriate utilization of approved Cardiovascular-Renal products. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. CR Consultant works closely with other commercial associates to generate pull-through within local payers, hospitals, community Health Care Providers. Fosters cardio-renal customer network development and communication. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. The CR consultant must demonstrate the ability to engage with customers through a variety of digital media and platforms (live, remote video conference, marketing email etc.) and integrate digital assets and strategies into broader territory-level business plans. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Supports the efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist with the delivery of optimal care. Requirements This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need. Cardiovascular-Renal Sales Consultant Requirements: Bachelor's degree preferred. At least three (3) years of experience in pharmaceutical sales of which one-plus (1+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. Hospital and/or Account Management experience preferred. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Executive Cardiovascular-Renal Sales Consultant I Requirements: Bachelor's degree preferred. At least five (5) years of experience in pharmaceutical sales of which two-plus (2+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. At least one-plus (1+) Hospital and/or Account Management experience required. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities: * Represents the assigned products to health care professionals in assigned sales territory. * Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. * Develop and execute comprehensive business plans. * Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices). * Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment. * Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products. * Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products. * Completes all assigned training. * Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. * Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities. * Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings. * Meet all administrative expectations and standards, including budgets, reporting, and communication. * Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. * Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. * Submits completed reports on-time and communicates matters that are relevant to the marketplace to the District Manager. * Maintains all equipment and territorial records in the prescribed manner. * Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. * Adhere to compliance and operating principles and expectations. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): * Bachelor's Degree required Experience Qualifications: * 4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required * 4 or More Years of oncology therapeutic experience strongly preferred * 1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred * Oncology product launch experience preferred * Copromotion experience a plus * Strong verbal and written communications skills * Proficiency in MS Word, Excel, PowerPoint and Outlook Additional Qualifications: * Must be able to travel approximately 40% to 60% * Must have a valid driver's license with a driving record that meets company Compensation and seniority level/title based on experience and qualifications Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $139,440.00 - $209,160.00 Download Our Benefits Summary PDF