Investigator jobs at Eurofins - 8 jobs

Job Title: Head of Global Investigative Toxicology About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. In the pharmaceutical industry, one of the major challenges in the discovery of innovative medicines is to ensure they are safe enough to serve patients - that is our mission. Drug safety is assessed throughout the R&D value chain, but it is during early drug discovery when we can actively design safety attributes into future candidate drug. We are supporting Drug Hunting partners in identification and optimization of new biological and synthetic molecule series applying cutting edge technologies pushing to the boundaries of predictive safety science with our mission in mind. We are also committed to the application of the 3Rs principles and to the implementation of New Alternative Methodologies (NAMs) in preclinical safety assessment. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: For our global investigative toxicology efforts we are looking for a strong Leader with focus on Investigative Toxicology. Activities include, but are not limited to: Leading our global investigative toxicology efforts with operations in Boston, Paris and Montpellier and with Senior Scientific Advisors serving as global safety experts in various toxicology disciplines based in multiple countries (France, US and Germany); develop/evolve strategy, ensure alignment and rationalization of activities across sites; ensure reaching out to internal and external ecosystem to develop/maintain networks and ensure access to appropriate methodologies/vendors; reach to other functions in R&D (Translational Medicine Unit, Research and Development) to share technologies / use synergies as applicable. Advice Preclinical Safety Project teams reps on building investigative toxicology strategy / review given strategies to progress projects successful overcoming challenges or rationale termination. Reporting to global Head PCS and Member of the global Leadership Team. Manage Senior Scientific Advisors globally. Strongly interact with Heads of Research Projects and Development projects Develop together innovative solutions and research proposals to pursue cutting edge science and technologies in order to optimize and influence translational safety assessment of novel drug targets. Facilitate and promote the use of new alternative methods (NAMs) in preclinical safety regulatory and non-regulatory testing. Serve globally as internal expert for discovery and development projects and design project-specific strategies to predict, assess and mitigate target- and modality-related safety risks and execute through internal and external experimental capabilities. Engage with experts across the organization to ensure that teams are able to make the right decisions regarding the translational safety risks associated with the project. Continuously interact with multiple R&D functions (TMU departments, Research and Development TAs, Research Platforms, etc ..) to identify opportunities to collaborate and utilize technologies across R&D more efficiently. Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities and contribute to Sanofi Outreach activities. Ensure high scientific standards / adhering to requested timelines in all aspects of the position. Supervision / Development of laboratory staff and global experts. About You Basic Qualifications: PhD or DVM and post-doctoral experience in toxicology, biochemistry, pharmacology, cell biology or systems biology. In addition, the candidate should have knowledge in biochemistry, toxicology, pharmacology, biology, physiology, and pathology. Solid understanding of the drug discovery and development process based on more than 20 years of experience in pharmaceutical industry in nonclinical drug safety and investigative toxicology. Demonstrated knowledge and experience investigating molecular mechanisms of drug action is critical. Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding. Knowledgeable about regulatory nonclinical testing requirements for pharmaceutical development of biologics and small molecules. Strong leadership competencies (as direct manager and transversal leader in a global and complex environment) and demonstrated experience. Preferred Qualifications: Highly motivated, creative, innovative, reliable scientist, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion. A social personality that contributes to an open, positive, collaborative working climate. Strong communication, presentation and influencing skills across levels/disciplines. DABT certification and experience as GLP Study Director is preferred, but not required. 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-SA #LI-SA #LI-Hybrid #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: $228,750.00 - $381,250.00 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.

is Grant Funded School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. Be You. Duke University's Marcus Center for Cellular Cures has an immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt Street Durham, NC. This position is currently on - site. The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies and will have experience transferring processes to cGMP facilities for clinical or commercial manufacture. They are expected to possess a high level of skill and experience with key bioprocess techniques and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Quality Assurance perspective for these processes. Minimum Qualifications: Education/Training Work generally requires a bachelor's degree in a biological Science. Experience Work requires six years of experience quality assurance or quality control related to clinical trials. A Master's degree in a related field may be substituted for 2 years of required experience or an equivalent combination of relevant education and/or experience. Preferred Qualifications: In addition, the preferred candidate will have experience with successfully seeing a product from process development to clinical trials and, if applicable, through commercial FDA-licensure. The preferred candidate would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits. More information about this lab is located at the link below: ********************************************************* MC3 Vision: To live in a world where every person has access to high quality and effective cell based therapies MC3 Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health Occupational Summary Enable compliance of the MC3's Carolinas Cord Blood Bank (CCBB) with FDA regulations and FACT accreditation standards. As directed by the GMP Compliance Associate Director, initiate and complete deviations and investigations, CAPAs, memos to file, complaints, and adverse events related to the collection, manufacturing and review of GMP cellular product. Collaborate with the Quality Systems Unit (QSU), collection, manufacturing and review teams to investigate errors and identify any Corrective and Preventative Actions (CAPAs). As applicable and as identified as part of a CAPA, develop and/or edit Standard Operating Procedures (SOPs) related to the manufacturing of GMP products in the CCBB to ensure compliance with FDA and other applicable requirements. Review/correct batch records as needed. Conduct internal program audits. Work Performed Enable compliance of the Carolinas Cord Blood Bank (CCBB) with FDA regulations and FACT accreditation standards. Assist in the process for FACT accreditation, performing gap analysis against the standards and identifying areas to fill, develop and update SOPs as needed to address those gaps. Educate staff regarding both new and updated policies and procedures, FACT standards, manuals, SOPs, training, and quality plans. Assist in inspections from FDA, FACT, and other agencies. Review observations and provide input to respond to the observations. As directed by the GMP Compliance Associate Director, and as related to CAPAs, develop and edit Standard Operating Procedures (SOPs) for the CCBB to ensure compliance with FDA and other applicable requirements. Edit batch records as needed. Initiate and complete deviations and investigations and CAPAs related to CCBB SOP excursions. Collaborate with QSU to investigate errors and complete deviations and CAPAs. Ensure timely signoff of deviations and CAPAs. Initiate, investigate and complete complaints and adverse events related to the collection and manufacturing and distribution of GMP cellular product. Review/correct batch records as needed. Prepare sites and manufacturing facility for inspections by these agencies and internal audits by performing periodic internal audits with a focus on review of equipment maintenance, safety procedures, training records, and SOP compliance. Serve as the liaison between the CCBB and QSU to schedule internal audits by QSU and collaborate with the respective CCBB area leaders to prepare a response to audit and inspection findings. Skills Other preferred skills include: Excellent communication skills, both written and oral Ability to pay attention to detail Excellent organizational skills Outstanding interpersonal skills Excellent analytical skills, good judgment, strong operational focus Self-directed team player Choose Duke. Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more. Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Basic Job Functions: This position will be responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues, ensuring all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards;. This position will collaborate with internal Subject Matter Experts (e.g. Analytical, Manufacturing, Packaging and Quality and IT personnel). Additionally, this role will work with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong computer skills as well as problem solving skills. Essential Functions of the Job: Lead investigations into Quality Events and customer complaints Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams Determine relevant corrective and preventative action Perform risk assessment to determine safety and efficacy of product Oversee timely completion of deviations, CAPAs, investigations, complaints Track and trend events/deviations Provide communication plans for ongoing deviations and CAPAs Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices Proactively raise quality related risks, issues, and opportunities. Support the organization in maintaining a work environment focused on quality, respect, open communication, collaboration, integration, and teamwork. Other duties as assigned.

Job Title: Distinguished Scientist, Head of Investigative Toxicology US About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The incumbent will be responsible for oversight and management of the Investigative Toxicology laboratory in the US and execution of strategies to strengthen and evolve liver and immune-related safety assessment, incorporating microphysiological systems (MPS) where needed. This candidate will ensure that Sanofi employs an evolving, innovative strategy for assessing liver and immune-related risks that align with regulatory guidance and scientific practice. This role will involve direct supervision of laboratory colleagues and/or lab heads working transversally with colleagues within PCS and across Sanofi sites, and external vendors, to provide project support and drive collaboration. This role will also be responsible for leading efforts and devising strategies to manage safety issues relevant to molecules at all stages of the Research and Development portfolio, and providing subject matter expertise related to liver safety. Participation in external consortia and representing Sanofi at relevant scientific venues is also an important component of this role. Terms of employment Occasional domestic and international travel to Sanofi Research and Development sites (e.g Paris, France; Frankfurt, Germany) and scientific meetings. Availability to start in 1Q2026. What makes this position unique? The candidate will be part of an established highly effective Investigative Toxicology group at Sanofi and have opportunity to manage a laboratory and help shape and guide research in the toxicology field, particularly with respect to liver safety assessment and application of MPS models. There is also the opportunity to learn and grow in the immunotoxicology area. There is tremendous opportunity for innovation within the role, and the global scope will provide the candidate with a rich, diverse work experience. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Supervise and manage colleagues in the US Investigative Toxicology group, including performance assessment and development planning; provide mentorship and guidance to support career growth. Provide technical expertise in model and assay development relevant for both liver and the immune system, ensuring sufficient scientific rigor. Oversee appropriate qualification/validation plans and testing strategies, particularly for the MPS models, to ensure robust performance. Define strategies and mechanistic experiments to understand safety issues; lead and manage execution of such strategies. Work collaboratively and transversally to ensure such strategies meet project and regulatory requirements; author reports to support inclusion of results in white papers or regulatory submissions as needed. Provide subject matter expertise on liver safety assessment and lead liver translational safety initiatives. Provide leadership regarding MPS models and in vitro new alternative models (NAMs) within Preclinical Safety and the broader Sanofi Research and Development organization. Participate in external consortia or working groups to stay abreast of liver safety knowledge and trends within the scientific community, regulatory environment, and the pharmaceutical industry. Represent Sanofi interests, maintaining high ethical and scientific standards. Author external presentations and manuscripts to contribute to scientific advancement of the toxicology field. About You Requirements & Qualifications A PhD in toxicology, pharmacology, biology, engineering, or equivalent scientific discipline required, with a minimum of 10 years of relevant experience in a pharmaceutical or biopharmaceutical setting. Knowledge and experience in liver toxicology and MPS models is required. Excellent management and leadership skills are essential. The ability to collaborate effectively with other scientists, subject matter experts and project teams is also essential. Experience working with immune models and immunotoxicology is a plus. Established record of scientific contribution in peer-reviewed journals and scientific symposiums. Excellent verbal and written communication skills are required. 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. Be part of an active, innovative scientific group Have diverse opportunities to collaborate on a global scale Be highly recognized for successes Receive excellent benefits and compensation 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-SA #LI-SA #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: $178,500.00 - $297,500.00 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.

Apply Description Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company's Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness. Essential Duties and Responsibilities: • Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA's) at Nephron Pharmaceuticals Corporation. • Responsible for assisting with tracking and trending data related to investigations. • Assists in developing and implementing project plans, processes, and systems to ensure timely project completion. • Assists with additional work duties or responsibilities as evident or required. • Performs other duties as assigned or apparent. Supplemental Functions: Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc. Maintains investigation files. Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records. Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes. Track and report investigation trends. Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs). Assist with the design and development of organizational training programs, tools, and processes to build quality. Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs). Reports any quality related issues to Director of Quality Assurance Investigations. Assist in other activities (as needed) for Quality Assurance management. Job Specifications and Qualifications: Knowledge & Skills: • Written and Oral communication skills. • Team Player, must be able to interact within the company with all departments. • Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred. • Experience in Root Cause Analysis and technical writing skills required. • Specific expertise, skills and knowledge within Quality Assurance gained through education and experience. • A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. • The ability to take strategic objectives and accept accountability to drive results through effective actions. • The ability and willingness to change direction and focus to meet shifting organizational and business demands. • The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. • The ability to take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity. • The ability to manage a multitude of resources and to be accurate and current with data and information. • Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing. • Incumbents required wearing specified protective equipment as necessary. • Salary range: Based on experience. • Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands. Education/Experience: • Bachelor's degree with 3-5 years of pharmaceutical experience in Quality Systems preferred. • 1-3 years of experience with MS Word, Excel, and PowerPoint preferred. • 1-2 years project management and coordination experience preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

**Job Title:** Head of Global Investigative Toxicology **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. In the pharmaceutical industry, one of the major challenges in the discovery of innovative medicines is to ensure they are safe enough to serve patients - that is our mission. Drug safety is assessed throughout the R&D value chain, but it is during early drug discovery when we can actively design safety attributes into future candidate drug. We are supporting Drug Hunting partners in identification and optimization of new biological and synthetic molecule series applying cutting edge technologies pushing to the boundaries of predictive safety science with our mission in mind. We are also committed to the application of the 3Rs principles and to the implementation of New Alternative Methodologies (NAMs) in preclinical safety assessment. **About Sanofi:** We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. **Main Responsibilities:** For our global investigative toxicology efforts we are looking for a strong Leader with focus on Investigative Toxicology. Activities include, but are not limited to: + Leading our global investigative toxicology efforts with operations in Boston, Paris and Montpellier and with Senior Scientific Advisors serving as global safety experts in various toxicology disciplines based in multiple countries (France, US and Germany); develop/evolve strategy, ensure alignment and rationalization of activities across sites; ensure reaching out to internal and external ecosystem to develop/maintain networks and ensure access to appropriate methodologies/vendors; reach to other functions in R&D (Translational Medicine Unit, Research and Development) to share technologies / use synergies as applicable. Advice Preclinical Safety Project teams reps on building investigative toxicology strategy / review given strategies to progress projects successful overcoming challenges or rationale termination. + Reporting to global Head PCS and Member of the global Leadership Team. + Manage Senior Scientific Advisors globally. + Strongly interact with Heads of Research Projects and Development projects + Develop together innovative solutions and research proposals to pursue cutting edge science and technologies in order to optimize and influence translational safety assessment of novel drug targets. + Facilitate and promote the use of new alternative methods (NAMs) in preclinical safety regulatory and non-regulatory testing. + Serve globally as internal expert for discovery and development projects and design project-specific strategies to predict, assess and mitigate target- and modality-related safety risks and execute through internal and external experimental capabilities. + Engage with experts across the organization to ensure that teams are able to make the right decisions regarding the translational safety risks associated with the project. + Continuously interact with multiple R&D functions (TMU departments, Research and Development TAs, Research Platforms, etc ..) to identify opportunities to collaborate and utilize technologies across R&D more efficiently. + Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities and contribute to Sanofi Outreach activities. + Ensure high scientific standards / adhering to requested timelines in all aspects of the position. + Supervision / Development of laboratory staff and global experts. **About You** **Basic Qualifications:** + PhD or DVM and post-doctoral experience in toxicology, biochemistry, pharmacology, cell biology or systems biology. In addition, the candidate should have knowledge in biochemistry, toxicology, pharmacology, biology, physiology, and pathology. + Solid understanding of the drug discovery and development process based on more than 20 years of experience in pharmaceutical industry in nonclinical drug safety and investigative toxicology. + Demonstrated knowledge and experience investigating molecular mechanisms of drug action is critical. + Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding. + Knowledgeable about regulatory nonclinical testing requirements for pharmaceutical development of biologics and small molecules. + Strong leadership competencies (as direct manager and transversal leader in a global and complex environment) and demonstrated experience. **Preferred Qualifications:** + Highly motivated, creative, innovative, reliable scientist, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion. + A social personality that contributes to an open, positive, collaborative working climate. + Strong communication, presentation and influencing skills across levels/disciplines. + DABT certification and experience as GLP Study Director is preferred, but not required. **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-SA \#LI-SA \#LI-Hybrid \#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: $228,750.00 - $381,250.00 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 (************************************************

Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The Quality Systems Investigator is responsible for evaluating, investigating, and strengthening the company's Quality Management System to ensure compliance with pharmaceutical regulatory requirements and industry standards. This role leads and supports thorough investigations of deviations, complaints, and quality events; identifies root causes; and ensures effective corrective and preventive actions are implemented. By monitoring system performance, assessing process controls, and driving continuous improvement, the Quality Systems Investigator helps ensure the consistent manufacture of safe, effective, and high-quality products while maintaining regulatory readiness. Essential Duties and Responsibilities: * Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPA's) at Nephron Pharmaceuticals Corporation. * Responsible for assisting with tracking and trending data related to investigations. * Assists in developing and implementing project plans, processes, and systems to ensure timely project completion. * Assists with additional work duties or responsibilities as evident or required. * Performs other duties as assigned or apparent. Supplemental Functions: * Manage investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc. * Maintains investigation files. * Performs initial and secondary review of compliant investigations and ensures accuracy and completeness of records. * Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes. * Track and report investigation trends. * Assist Continuous Improvement Quality Manager with areas of improvement and provide insight for Quality Improvement Plans (QIPs). * Assist with the design and development of organizational training programs, tools, and processes to build quality. * Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. * Support all departments with investigations, complaints, audit response, process improvement and training for deviations and complaints as well as the subsequent Corrective and Preventative Actions (CAPAs). * Reports any quality related issues to Director of Quality Assurance Investigations. * Assist in other activities (as needed) for Quality Assurance management. Job Specifications and Qualifications: Knowledge & Skills: * Written and Oral communication skills. * Team Player, must be able to interact within the company with all departments. * Pharmaceutical experience with equipment, instrumentation, production, maintenance and engineering preferred. * Experience in Root Cause Analysis and technical writing skills required. * Specific expertise, skills and knowledge within Quality Assurance gained through education and experience. * A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. * The ability to take strategic objectives and accept accountability to drive results through effective actions. * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. * The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. * The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. • The ability to take strategic objectives and accept accountability, motivate and influence others. Think globally, and leverages diversity. * The ability to manage a multitude of resources and to be accurate and current with data and information. * Position requires lifting (up to 40lbs), vision (20/20), standing (10%), walking (50%), talking, typing and hearing. * Incumbents required wearing specified protective equipment as necessary. • Salary range: Based on experience. * Hours of work: Monday through Friday on an 8-hour shift, or as needed based on company demands. Education/Experience: * Bachelor's degree with 3-5 years of pharmaceutical experience in Quality Systems preferred. * 1-3 years of experience with MS Word, Excel, and PowerPoint preferred. * 1-2 years project management and coordination experience preferred. Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace. Requirements