Daiichi Sankyo jobs - 92 jobs

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

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 semi-automatic 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 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. * Staff 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. 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. 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 2 years 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 stand in one place for prolonged periods of time, monitoring equipment and processes. * 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 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. * Physically able to work using restricted access barrier (RABS) or isolation containment devices. * Physically able to stand for long periods of time. * Must maintain cleanroom gowning and respirator fit testing requirement. 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 **************************************.

Compensation Data Compensation: This position offers a base salary typically between $140,000 and $219,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description 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. The Senior Associate Director, National Acct and Sales Retail is responsible for the management of the assigned Customers and account managers. The incumbent will develop the retail strategy for their relevant channel of assigned customers, and the implementation of the Boehringer sales/marketing plan to assure maximum distribution and market penetration of Boehringer products. Responsibilities for this role include achieving net sales, profit, and market share goals, and delivering against customer KPIs. The incumbent will manage a team of account managers, across relevant portfolio of customers. This role will support the leadership of the sales functional by developing key internal relationships, as well as external. This position has responsibility for key additional projects which support the continued development and future strategy of the sales organization. Remote based role. Locations: Duluth, GA or Seattle, WA Duties & Responsibilities Works with and through assigned customers and Key Account Managers to ensure sales performance meets or exceeds annual Company sales and market share objectives. Implements a sales strategy to be executed through their relevant channel and Key Account Managers. Exercises fiscal control on allocated operating budgets across multiple customers. Manages across multiple customers. Responsible for setting of annual KPIS. Works to improve to sales bench of the organization, with the Head of Sales. Utilizes appropriate data sources to develop tactical plans and to develop future customer / channel strategy. Actively monitors progress of work, cross-functional activities, and accountability. Plans and executes meetings that effectively implement objectives and strategies as determined by the Company. Spends appropriate amount of time developing customers, networks, and their relationships to foster Company business. Leads the senior customer engagement strategy across the channel, ensuring relevant T2T, strategic customer meetings and line reviews are delivered. Develops positive relationships with Company internal customers, such as supply, marketing, Segment Leads. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, OSHA, etc.) and Company policies and procedures. Demonstrates high ethical and professional standards with all business contacts to maintain BIAH's excellent reputation within the community. Leads special strategic projects as relevant, which will ensure future success of the retail sales team. Requirements BS/BA. Minimum of eight to ten (8-10) years successful commercial industry experience. Minimum of five to seven (5-7) years retail experience, across Omni channel, ideally in US Mass market, E-commerce, or Retail Pharmacy. Understanding of retail analytics, economics, supply chain, and consumer insights. Understanding of the digital environment, e.g., E-Commerce and digital marketing. Understanding of the US retail environment. Experience in working cross-functionally. Project Management Skills. Proficiency in Excel, Word, Outlook, PowerPoint, and database applications. Ability to travel. 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.

The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform manual inspection and train in the automatic inspection/packaging area for setup, of automated equipment and manual inspection processes, labeling and packaging equipment duties, line clearances and assist with inspection/packaging schedule. In conjunction with the Supervisor, the Technician plays a critical role in assuring safe, effective and compliant activities are performed in the manual inspection process while maintaining production schedules. The Equipment and Process Technician I will be proficient in all activities associated with the inspection process and be able to work with minimal supervision. The Technician will receive direction, training and mentorship from the Supervisor of Inspection and Packaging. 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. * Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor. * Maintains accurate and complete records. * Maintains an accurate and complete Training Record. * Ability to set-up Manual Inspection process with little to no assistance. * Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities. * Physically performs inspection reconciliation and provides documentation oversight and acknowledgement for such activities. * Ability to review executed batch records and log books prior to submitting for final Production review. * Provides accurate and complete assistance to Quality Assurance as needed. * Works in a safe and effective manner. * Identifies and reports unsafe and non-compliant conditions. * Maintains work space in a clean and orderly manner. * Perform any other tasks/duties as assigned by management. * We all must embrace the QUALITY culture. QUALIFICATIONS AND REQUIREMENTS * High School diploma or GED preferred. Some college or technical training is a plus. * Minimum 1-year work experience in inspection, packaging, quality control and/or production preferred. * Must be able to work independently, completing assigned tasks with limited supervision. * Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages. * Excellent organizational, interpersonal and communication skills (oral and written). * Ability to take feedback constructively and consider the viewpoints of others. * 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, and protective gloves. PPE is 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. * Employee must be able to occasionally lift and/or move up to 50 pounds. * Must be able to sit for extended hours, focusing and concentrating on items being inspected. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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 **************************************.

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 **************************************.

Support the early Oncology clinical drug research and development process by providing strategic planning and execution, including clinical trial design and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. Represent biostatistics and coordinate the inputs from programing and data management at a substance/asset level regarding data science related aspects. Collaborate with cross-functional teams to design, evaluate, and optimize clinical trial strategies and development scenarios. 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** + Lead and oversee designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects with established BI experience . + Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset. + Develop and implement fit-for-purpose statistical designs and Go/NoGo decision frameworks through simulations and scenario planning to ensure high-quality evidence generation. + Keep abreast of data science within and outside BI. Apply advanced statistical methodologies and turn derived insights into new data science approaches for early Oncology clinical development. + Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models. + Present compelling validated stories regarding complex data science aspects to Biostatistics colleagues and other professionals within and outside of BI. + If applicable, supports the clinical drug development process up to the level of substance/assets. + Guide and/or lead other colleagues, internal and external customer and external providers on data science related tasks. + Coordinate cross-functional working with programming and data management. + Be a team player and contribute to cross-functional collaborations. + Supports regulatory interactions by ensuring statistical rigor in evidence strategies. + Participate in cross-functional BI internal working-groups and drive/plan relevant data science aspects. Participate in external working groups. + Liaise with late phase Oncology Biostatistics and Data Science team to leverage synergies and share knowledge. **SR AD:** In addition to what is listed above, you will also be responsible for the following: + Subject Matter Expert (SME) / Process Lead for designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects, that represent new challenges and for which project and therapeutic knowledge is not given. + Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting of other data that represent new challenges from research and development like registries and real-world databases. + Identify trends in data science within and outside BI. + Lead cross-functional BI internal working-groups and drive/plan relevant data science aspects. + Foster innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models. + If applicable, supports the clinical drug development process up to the level of Therapeutic Area/assets. **Requirements** **AD Requirements:** + Bachelor of Science with a minimum of **seven (7) years** ; Or Master of Science with **six (6) years** of experience OR Doctoral Degree (PhD) with **three (3) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions. + Working experience might be partially compensated by broad and deep topic-specific knowledge. + Broad knowledge and advanced experience in software languages relevant for business needs and understanding of clinical trial development process required. + Advanced project lead experience required. + Understanding and applying key of principles of data science. + In-depth understanding of advanced statistical concepts related to Data Science. + Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development. + Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information. + Advanced working knowledge of broad variety of aspects of relevant software languages. + Abilitiy to lead and facitlitate meetings as well as develop and deliver trainings related to data science. + Language skills: English: fluent (Read/Write/Speak).Know, understand, and implement: + International regulations and guidelines for good clinical and statistical practice from all ICH regions, + The various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and + BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan). **SR AD Requirements:** + Bachelor of Science with a minimum of **ten (10) years** ; Or Master of Science with **ten (10) years** of experience OR Doctoral Degree (PhD) with **six (6) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions. In addition to what is listed above, the following is required: + Demonstrated comprehensive knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex situations that represent new challenges and for which project and therapeutic knowledge is not given. + Excellent knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information. + Advanced understanding of cutting-edge statistical concepts related to Data Science. + Comprehensive working knowledge of broad variety of aspects of relevant software languages. **Desired Skills, Experience and Abilities** + Basic medical understanding of Oncology disease areas, including familiarity with clinical endpoints, RECIST criteria, cancer-related terminology, and therapeutic strategies. + Familiarity with Oncology translational endpoints (e.g., exploratory or early surrogate markers) and statistical modeling for translational research. **Compensation:** This position, AD, Principal Clinical Data Scientist, offers a base salary typically between $140,000.00 and $222,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (***************************************************************** **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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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 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 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 **************************************.

The Study Physician (SP) is a critical role within Clinical Development Oncology (CD Onc) to establish readily available medical support and consultancy for clinical trials within CD Onc by a qualified and clinically experienced physician. 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** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. + Responsible for medical input into CTP updates. + Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Responsible for execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Takes medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. + Supports close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively addresses/communicates clinical quality issues in a collaborative environment. + Contributes to the timely preparation of medically relevant core trial documents and timely milestones. + Responsible for medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing. + Responsible for "Information for CRF completion" (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc. + Responsible for medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report. + Contributes to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Responsible for medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Responds to medical queries from Investigators, CROs and/or Sponsor team representatives and contributes to maintenance of trial FAQ log/list. + Builds network with experts and active contribution to site engagement. + Supports Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. + Responsible for medical review of and contribution to the content of Trial Newsletters. + Contributes to the scientific publication of trial data (If applicable). **Requirements** + Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of four (4) years of active clinical practice experience; specialization in internal medicine or general practice is desirable. MD in Oncology is preferred. + Experience specifically in Oncology Clinical Development is preferred. + Experience in pharma industry or CRO in medical or project management functions (ideally in Clinical Development) is desirable + Ability to communicate directly and concisely while collaborating with key stakeholders. + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills. + Capability to work proactively and with team spirit in an international environment and team. + Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment. + Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken. **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. **Compensation** This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits, please click here. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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 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 **************************************.

**Job title:** HSE & Operational excellence manager _% Remote working and % of travel expected:_ 100% on-site, < 5% travel expected **About the job** The SMS Lead- HSE Champion is responsible for leading Health, Safety, and Environmental (HSE) initiatives and supporting Manufacturing Excellence (ME) programs within Pearl River operations. This role ensures compliance with regulatory and internal standards, drives continuous improvement, and fosters a culture of safety and operational excellence across all levels of the organization. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. **Main responsibilities** **HSE Champion Responsibilities:** HSE Communications & Culture: + Cascade monthly HSE updates, KPIs, audit results, and program changes. + Share best practices and lessons learned across departments. + Support site programs in industrial hygiene, biosafety, fire and life safety, occupational safety, process safety, and environmental compliance. + Attend and contribute to monthly HSE meetings. Safety Program Management: + Maintain and update JHAs and annual risk maps. + Coordinate product stewardship activities (e.g., SDS updates, chemical inventory). + Ensure compliance with medical surveillance and task-based risk assessments. + Support regulatory compliance activities (e.g., hazardous waste management, spill response, ASTs, energy control/LOTO, contractor safety). Incident & Compliance Management: + Initiate and manage accident investigations in Qualipso. + Own and track action plans and link incidents to risk profiles. + Conduct internal audits and inspections; ensure compliance with regulatory standards (e.g., hazardous waste, ASTs, KSEs). + Initiate and manage accident/incident investigations in Qualipso, ensuring timely root cause analysis and corrective/preventive actions (CAPAs). Shop Floor Engagement + Lead Gemba walks and MSV (Managing for Safety & Value) schedules. + Support coactivity planning, permit-to-work processes, and emergency drills (fire, spill, MERT, biohazard). + Deliver onboarding training for non-GMP areas. + Maintain and update safety maps and visual management tools. Escalation & Continuous Improvement: + Act as a liaison between area managers, HSE, and maintenance for escalations. + Identify and escalate improvement ideas. + Monitor and trend safety and performance data (e.g., SRR, MSV, injuries, incidents). Operational Excellence Responsibilities: + Continuous Improvement & Culture Building + Support site-wide continuous improvement initiatives using structured tools, templates, and internal communications. + Lead proactive learning activities such as After Action Reviews, cross-functional workshops, and kaizen events. + Promote a culture of operational excellence and employee engagement. KPI Management & Performance Tracking: + Manage operational KPIs (e.g., +QDCI) and facilitate cascaded reviews from shop floor to senior leadership. + Ensure alignment of performance metrics with site goals and strategic priorities. Data Analytics & Visualization: + Ensure data quality and integrity for global performance dashboards and reporting systems. + Utilize tools such as Power BI and iObeya to visualize trends and support decision-making. **About You** _Education:_ Bachelor's degree in Occupational Health and Safety, Engineering, or related field. _Experience:_ 3+ years in HSE or manufacturing operations, preferably in a regulated industry. _Technical Skills:_ + Proficiency in Microsoft Office, Power BI, iObeya, Qualipso, and EHS Desk. + Familiarity with MSDS Online, SEDDA, and risk assessment tools. + Understanding of chemical and biological safety is a plus. + **Certifications** : OSHA 30 hour (general industry or Construction) or similar certifications are preferred. _Soft Skills:_ + Strong communication and coaching abilities. + Analytical mindset with attention to detail. + Ability to lead cross-functional teams and influence without authority. **Why choose us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SP \#LI-SP \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $74.250,00 - $123.750,00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

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 **************************************.

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. Our ambition is to improve and save lives for the millions of people who are living with the complexities of Cardiovascular, Renal & Metabolic (CVRM) diseases. AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases today and tomorrow with our strong and expanding portfolio and one of the broadest, deepest, most innovative pipelines in the industry. By 2032, we intend to be leading the world in CVRM therapies, launching up to 15 new life-changing medicines. To support our future growth, we have an exciting opportunity as a Primary Care Sales Representative to launch a best in class hypertension asset. 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 The annual base pay (or hourly rate of compensation) for this position ranges from $76,935 to $177,882. 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. 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 17-Dec-2025 Closing Date 01-Jan-2026 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.

**Compensation Data** This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** . **Description** 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. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. **Duties & Responsibilities** - Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. - As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. - Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. - Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. - Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. - Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. - Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. - Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. - Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. - Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. **Requirements** - Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. - 10+ years of professional experience in a scientific, clinical, and/or medical space. - Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. - Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. - Experience in (at least passion for) storytelling. - Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. - Demonstrated experience presenting to scientific and non-scientific audiences. - Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. - Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. - Expertise in globalizing functions to operate in a standardized fashion. - Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. - Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position - Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. - Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. - **Remote*:** this position is considered remote based. **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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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.

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 **************************************.

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 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 **************************************.