Manufacturing Leader jobs at Takeda Pharmaceuticals U.S.A., Inc. - 619 jobs

A global biopharmaceutical company in Boston is looking for a Global Therapeutic Research Lead to drive critical drug discovery projects within the Neuroscience Drug Discovery Unit. This role requires an advanced degree and extensive industry experience, emphasizing leadership in drug discovery from target identification to clinical development. Ideal candidates will have a proven track record in managing strategic projects and collaborating effectively across teams to foster innovation and excellence. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a Global Commercial Director for Immunology Cell Therapy based in Boston. In this role, you will develop and implement commercial strategies and lead initiatives for launching new therapies in the market. Ideal candidates will have over 10 years of experience in pharmaceutical development and a strong understanding of commercial strategies. This position offers a salary range of $229,303 to $343,955 annually, along with various benefits, including health coverage and retirement plans. #J-18808-Ljbffr

A global pharmaceutical company is seeking a finance professional to contribute to the Global Finance function, supporting senior executives while managing key stakeholders. The ideal candidate will have a strong background in finance, including an MBA and extensive experience across global organizations. Responsibilities include developing finance strategies, maintaining internal and external relationships, and leading teams. Competitive compensation and benefits are offered, making this an attractive opportunity for qualified candidates. #J-18808-Ljbffr

Manufacturing Test Engineering Manager (or Senior/Lead Test Engineer) Red Oak Technologies is partnering with our client, a leader in LiDAR sensor technology, to identify a highly skilled Manufacturing Test Engineering Manager. We are open to considering strong Senior or Lead-level Test Engineers who are ready to take on team leadership responsibilities while continuing to code daily. This role is fully onsite in San Francisco, CA. Position Overview The Manufacturing Test Engineering Manager will be a hands-on technical leader responsible for developing and maintaining production test software for high-volume LiDAR sensor manufacturing. The ideal candidate will have strong Python development skills, proven experience in test engineering for electro-mechanical assemblies, and the ability to mentor and guide a team while contributing individually on a daily basis. The role requires close collaboration with cross-functional teams to improve test coverage, reduce test time, and ensure production readiness as new products move from development into manufacturing. Key Responsibilities Develop, maintain, and improve production test software using Python for LiDAR sensor and sub-assembly manufacturing. Serve as a working manager, providing technical leadership while contributing hands-on daily. Mentor and train Test Engineers on both technical and soft skills. Establish team priorities, KPIs, and work goals aligned with product development schedules and company objectives. Collaborate with cross-functional teams on software development, verification, and validation for new product introductions. Drive continuous improvement initiatives, including test time reduction, data quality enhancements, and production process optimization. Apply software engineering best practices, including coding standards, code reviews, source control management, CI/CD pipelines, and test automation. Communicate project updates, risks, and recommendations to management and stakeholders. Ensure timely completion of team deliverables and proactively address constraints or delays. Support contract manufacturing facilities with occasional travel (less than 10%). Work full-time onsite in San Francisco, CA. Qualifications and Skills Strong proficiency in Python development (minimum 5 years). Experience with CI/CD infrastructure, GitLab, Jenkins, and SQL database design. Strong skills in debugging, programming, data collection, and data analysis. Experience using project tracking tools such as Jira, Confluence, or equivalents. Proven ability to deliver results in a fast-paced engineering environment. Excellent organizational skills with the ability to manage multiple concurrent projects. Demonstrated people management or technical leadership experience (3+ years preferred). Experience working with high-precision electro-mechanical assemblies. Preferred: Experience developing test software for high-volume production and test equipment. Education BS in Computer Science, Mechatronics, Mechanical Engineering, or a related technical field required. MS degree preferred. Additional Information Background screening is conducted by the client. The Manufacturing group has zero tolerance for misdemeanor or felony theft or robbery offenses. This position is within an electrical component manufacturing environment (not medical devices). About Red Oak Technologies Since 1995, Red Oak Technologies has been a trusted partner in the technology industry, specializing in identifying and placing highly skilled contract, permanent, and project-based professionals. We value diversity and welcome applicants from all backgrounds and experiences. Red Oak Core Values: Relationships First | Exceptional Quality and Service | Unwavering Integrity and Trust | Be Easy To Do Business With | Respect Everyone

Title: Associate Director, Thought Leader Liaison (Hematology) A small biotech company is seeking an experienced and strategic professional to join their hematology marketing team. The TLL will serve as a key field-based marketing leader, responsible for engaging Key Opinion Leaders and advocacy groups to support the growth of their innovative product portfolio. This role will also collaborate closely with field sales and internal stakeholders to gather market insights, build advocacy, and ensure alignment of marketing strategies with regional needs. Key Responsibilities: Identify, profile, and maintain long-term relationships with KOLs in assigned region Build advocacy for brands through on-label discussions and disease state education Identify and develop potential speakers for educational programs Drive pull-through of marketing strategy within field sales teams Coordinate activities with Sales, Marketing, and Market Access teams Support training initiatives during POAs and field rides Qualifications: 7+ years of pharmaceutical/biotech experience + minimum 3 years in oncology or hematology Prior experience in a TLL role or extensive KOL relationships with academic oncologists Strong leadership and cross-functional collaboration skills Ability to travel extensively (70%) Bachelor's degree in science or business-related discipline EPM Scientific is the only search firm dedicated to offering bench to bedside recruitment services with niche experts across every vertical of the development, approval, and launch cycle. Please note: Applicants who do not meet the above requirements will not be considered for this role.

Direct Reports: 2-3 This role supports a well-established manufacturing operation with a strong focus on safety, environmental responsibility, and regulatory compliance. The EHS Supervisor will play a key leadership role on site, overseeing environmental health and safety programs with direct responsibility for industrial wastewater compliance. This position combines hands-on technical work with people leadership and cross-functional collaboration in a stable, process-driven manufacturing environment. What We Offer Competitive salary aligned with experience and licensure Stable, long-term opportunity in a manufacturing environment Clear ownership of environmental and safety programs with leadership visibility Support for compliance-driven decision making and continuous improvement Opportunity to lead and develop a small EHS-focused team Onsite role with consistent schedule and defined scope of responsibility What You Need South Carolina Physical/Chemical Wastewater Operator License - Class A or B (required) Experience working in a manufacturing or industrial environment Working knowledge of: Industrial wastewater treatment systems and processes Environmental permits, reporting, and regulatory compliance (SC DHEC) OSHA regulations and workplace safety standards Prior experience supervising employees or leading teams Strong documentation, organizational, and communication skills Ability to balance hands-on technical work with leadership and compliance responsibilities Preferred: 3-7+ years of EHS experience in an industrial or manufacturing setting Experience supporting regulatory inspections and audits Familiarity with environmental and safety management systems (ISO 14001 / ISO 45001 or similar) What Your Role Will Look Like Serve as the licensed operator responsible for industrial physical/chemical wastewater compliance Oversee daily operation, monitoring, sampling, and documentation of wastewater treatment systems Ensure compliance with environmental permits, reporting requirements, and regulatory standards Lead site EHS programs including safety training, incident investigation, and corrective actions Supervise, coach, and develop 2-3 direct reports, ensuring adequate coverage and performance Conduct internal audits and support external regulatory or customer audits Partner with operations, maintenance, and engineering teams to support safe, compliant processes Track and report EHS and environmental performance metrics Drive continuous improvement in safety culture and environmental compliance

**Job Title:** Transformation Leader - External Manufacturing - Biologics **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. ****This is a hybrid role - 3 days a week onsite - required. **** **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:** **Support Transformation Delivery** + Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. + Localize change strategies to fit the GBU context, culture, and priorities. + Act as a key point of contact for all change-related activities in the GBU. **Drive Adoption & Engagement** + Ensure employees and managers understand the why, what, and how of transformation initiatives. + Develop and execute communication and training plans to maximize adoption. + Monitor adoption and embed new behaviors, processes, and tools into the GBU. **Stakeholder & Leadership Support** + Build strong relationships with GBU leaders to support them as change sponsors. + Provide coaching and guidance to managers and teams to reinforce change behaviors. + Act as a trusted advisor to GBU leadership on change readiness and risks. **Change Measurement & Reporting** + Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. + Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. + Capture lessons learned to continuously improve change implementation in the GBU. **About You** + Bachelor's degree in Business, Human Resources, Organizational Development, or related field. + 5+ years of experience in change management or organizational transformation. + Strong knowledge of CMO/CDMO manufacturing - Required. + Strong knowledge of change management frameworks + Demonstrated ability to work in complex, matrixed organizations. + Excellent communication, facilitation, and interpersonal skills. + Proven track record in supporting digital, operational, or organizational transformation programs. + Certification in Change Management or Project Management is a plus. **Key Competencies of a Transformation Leader** As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: **Vision & Strategy** + Strategic thinking: Ability to see the "big picture" and anticipate trends + Organizational alignment: Connect transformation to business objectives **Change Management** + Change management: Master methodologies + Resistance management: Identify and address barriers to change + Change communication: Adapt messages to different audiences **Operational Competencies** + Project/Program Management + Business acumen with ability to translate transformation into operational impact. + Problem-solving and analytical thinking. + Process optimization: Identify and implement improvements + Digital literacy: Understand emerging technologies (AI, automation, cloud) + Innovation: Promote experimentation and learning **Relational Competencies /Leadership & Influence** + **Cross-functional work: Orchestrate multi-functional teams** + Inspirational leadership: Mobilize and engage teams + Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. + Emotional intelligence: Understand and manage emotions during change change + Negotiation: Find compromises and create consensus **Soft Skills** + **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling) + **Empathy** : Understand the human impact of change + **Resilience** and **adaptability** in dynamic environments. **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-SG \#LI-GZ \#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: $147,000.00 - $212,333.33 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 (************************************************

Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. This is a hybrid role - 3 days a week onsite - required. 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: Support Transformation Delivery * Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. * Localize change strategies to fit the GBU context, culture, and priorities. * Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement * Ensure employees and managers understand the why, what, and how of transformation initiatives. * Develop and execute communication and training plans to maximize adoption. * Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support * Build strong relationships with GBU leaders to support them as change sponsors. * Provide coaching and guidance to managers and teams to reinforce change behaviors. * Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting * Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. * Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. * Capture lessons learned to continuously improve change implementation in the GBU. About You * Bachelor's degree in Business, Human Resources, Organizational Development, or related field. * 5+ years of experience in change management or organizational transformation. * Strong knowledge of CMO/CDMO manufacturing - Required. * Strong knowledge of change management frameworks * Demonstrated ability to work in complex, matrixed organizations. * Excellent communication, facilitation, and interpersonal skills. * Proven track record in supporting digital, operational, or organizational transformation programs. * Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy * Strategic thinking: Ability to see the "big picture" and anticipate trends * Organizational alignment: Connect transformation to business objectives Change Management * Change management: Master methodologies * Resistance management: Identify and address barriers to change * Change communication: Adapt messages to different audiences Operational Competencies * Project/Program Management * Business acumen with ability to translate transformation into operational impact. * Problem-solving and analytical thinking. * Process optimization: Identify and implement improvements * Digital literacy: Understand emerging technologies (AI, automation, cloud) * Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence * Cross-functional work: Orchestrate multi-functional teams * Inspirational leadership: Mobilize and engage teams * Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. * Emotional intelligence: Understand and manage emotions during change change * Negotiation: Find compromises and create consensus Soft Skills * Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) * Empathy: Understand the human impact of change * Resilience and adaptability in dynamic environments. 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-SG #LI-GZ #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: $147,000.00 - $212,333.33 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.

Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a “local transformation enabler”: ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. **This is a hybrid role - 3 days a week onsite - required. ** 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: Support Transformation Delivery Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. Localize change strategies to fit the GBU context, culture, and priorities. Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement Ensure employees and managers understand the why, what, and how of transformation initiatives. Develop and execute communication and training plans to maximize adoption. Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support Build strong relationships with GBU leaders to support them as change sponsors. Provide coaching and guidance to managers and teams to reinforce change behaviors. Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. Capture lessons learned to continuously improve change implementation in the GBU. About You Bachelor's degree in Business, Human Resources, Organizational Development, or related field. 5+ years of experience in change management or organizational transformation. Strong knowledge of CMO/CDMO manufacturing - Required. Strong knowledge of change management frameworks Demonstrated ability to work in complex, matrixed organizations. Excellent communication, facilitation, and interpersonal skills. Proven track record in supporting digital, operational, or organizational transformation programs. Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy Strategic thinking: Ability to see the "big picture" and anticipate trends Organizational alignment: Connect transformation to business objectives Change Management Change management: Master methodologies Resistance management: Identify and address barriers to change Change communication: Adapt messages to different audiences Operational Competencies Project/Program Management Business acumen with ability to translate transformation into operational impact. Problem-solving and analytical thinking. Process optimization: Identify and implement improvements Digital literacy: Understand emerging technologies (AI, automation, cloud) Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence Cross-functional work: Orchestrate multi-functional teams Inspirational leadership: Mobilize and engage teams Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. Emotional intelligence: Understand and manage emotions during change change Negotiation: Find compromises and create consensus Soft Skills Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) Empathy: Understand the human impact of change Resilience and adaptability in dynamic environments. 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-SG #LI-GZ #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: $147,000.00 - $212,333.33 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.

**Job Title:** Transformation Leader - External Manufacturing - Biologics **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. ****This is a hybrid role - 3 days a week onsite - required. **** **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:** **Support Transformation Delivery** + Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. + Localize change strategies to fit the GBU context, culture, and priorities. + Act as a key point of contact for all change-related activities in the GBU. **Drive Adoption & Engagement** + Ensure employees and managers understand the why, what, and how of transformation initiatives. + Develop and execute communication and training plans to maximize adoption. + Monitor adoption and embed new behaviors, processes, and tools into the GBU. **Stakeholder & Leadership Support** + Build strong relationships with GBU leaders to support them as change sponsors. + Provide coaching and guidance to managers and teams to reinforce change behaviors. + Act as a trusted advisor to GBU leadership on change readiness and risks. **Change Measurement & Reporting** + Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. + Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. + Capture lessons learned to continuously improve change implementation in the GBU. **About You** + Bachelor's degree in Business, Human Resources, Organizational Development, or related field. + 5+ years of experience in change management or organizational transformation. + Strong knowledge of CMO/CDMO manufacturing - Required. + Strong knowledge of change management frameworks + Demonstrated ability to work in complex, matrixed organizations. + Excellent communication, facilitation, and interpersonal skills. + Proven track record in supporting digital, operational, or organizational transformation programs. + Certification in Change Management or Project Management is a plus. **Key Competencies of a Transformation Leader** As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: **Vision & Strategy** + Strategic thinking: Ability to see the "big picture" and anticipate trends + Organizational alignment: Connect transformation to business objectives **Change Management** + Change management: Master methodologies + Resistance management: Identify and address barriers to change + Change communication: Adapt messages to different audiences **Operational Competencies** + Project/Program Management + Business acumen with ability to translate transformation into operational impact. + Problem-solving and analytical thinking. + Process optimization: Identify and implement improvements + Digital literacy: Understand emerging technologies (AI, automation, cloud) + Innovation: Promote experimentation and learning **Relational Competencies /Leadership & Influence** + **Cross-functional work: Orchestrate multi-functional teams** + Inspirational leadership: Mobilize and engage teams + Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. + Emotional intelligence: Understand and manage emotions during change change + Negotiation: Find compromises and create consensus **Soft Skills** + **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling) + **Empathy** : Understand the human impact of change + **Resilience** and **adaptability** in dynamic environments. **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-SG \#LI-GZ \#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: $147,000.00 - $212,333.33 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 (************************************************

Job Title: Transformation Leader - External Manufacturing - Biologics About the Job Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. This is a hybrid role - 3 days a week onsite - required. 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: Support Transformation Delivery * Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. * Localize change strategies to fit the GBU context, culture, and priorities. * Act as a key point of contact for all change-related activities in the GBU. Drive Adoption & Engagement * Ensure employees and managers understand the why, what, and how of transformation initiatives. * Develop and execute communication and training plans to maximize adoption. * Monitor adoption and embed new behaviors, processes, and tools into the GBU. Stakeholder & Leadership Support * Build strong relationships with GBU leaders to support them as change sponsors. * Provide coaching and guidance to managers and teams to reinforce change behaviors. * Act as a trusted advisor to GBU leadership on change readiness and risks. Change Measurement & Reporting * Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. * Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. * Capture lessons learned to continuously improve change implementation in the GBU. About You * Bachelor's degree in Business, Human Resources, Organizational Development, or related field. * 5+ years of experience in change management or organizational transformation. * Strong knowledge of CMO/CDMO manufacturing - Required. * Strong knowledge of change management frameworks * Demonstrated ability to work in complex, matrixed organizations. * Excellent communication, facilitation, and interpersonal skills. * Proven track record in supporting digital, operational, or organizational transformation programs. * Certification in Change Management or Project Management is a plus. Key Competencies of a Transformation Leader As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: Vision & Strategy * Strategic thinking: Ability to see the "big picture" and anticipate trends * Organizational alignment: Connect transformation to business objectives Change Management * Change management: Master methodologies * Resistance management: Identify and address barriers to change * Change communication: Adapt messages to different audiences Operational Competencies * Project/Program Management * Business acumen with ability to translate transformation into operational impact. * Problem-solving and analytical thinking. * Process optimization: Identify and implement improvements * Digital literacy: Understand emerging technologies (AI, automation, cloud) * Innovation: Promote experimentation and learning Relational Competencies /Leadership & Influence * Cross-functional work: Orchestrate multi-functional teams * Inspirational leadership: Mobilize and engage teams * Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. * Emotional intelligence: Understand and manage emotions during change change * Negotiation: Find compromises and create consensus Soft Skills * Communication: Strong communication and facilitation skills (Clarity, active listening, storytelling) * Empathy: Understand the human impact of change * Resilience and adaptability in dynamic environments. 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-SG #LI-GZ #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: $147,000.00 - $212,333.33 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.

**Job Title:** Transformation Leader - External Manufacturing - Biologics **About the Job** Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster. EM&S is leading the SANOFI CMO network and is committed to engage and manage external partners delivering exceptional manufacturing solutions. As we embark on a journey of growth and expansion, we are seeking a dynamic and experienced professional to lead our Business Transformation efforts in EM&S Spe Care. The Transformation Leader at the EM&S GBU level plays a key role in supporting transformation initiatives within the EM&S GBU. Acting as the primary link between the central transformation office and local EM&S GBU teams, the Transformation Leader ensures that projects are successfully adopted and embedded into daily operations. This role is focused on driving engagement, building change readiness, and ensuring that the transformation objectives deliver sustainable impact within the GBU. This positioning makes the Transformation Leader a "local transformation enabler": ensuring alignment with global vision, while guaranteeing practical adoption and ownership in the GBU. ****This is a hybrid role - 3 days a week onsite - required. **** **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:** **Support Transformation Delivery** + Partner with the Global Transformation Leader to implement enterprise-wide programs within the GBU. + Localize change strategies to fit the GBU context, culture, and priorities. + Act as a key point of contact for all change-related activities in the GBU. **Drive Adoption & Engagement** + Ensure employees and managers understand the why, what, and how of transformation initiatives. + Develop and execute communication and training plans to maximize adoption. + Monitor adoption and embed new behaviors, processes, and tools into the GBU. **Stakeholder & Leadership Support** + Build strong relationships with GBU leaders to support them as change sponsors. + Provide coaching and guidance to managers and teams to reinforce change behaviors. + Act as a trusted advisor to GBU leadership on change readiness and risks. **Change Measurement & Reporting** + Track change adoption KPIs and report progress to the Transformation Leader and GBU leadership. + Identify resistance, barriers, and adoption gaps, and proactively recommend solutions. + Capture lessons learned to continuously improve change implementation in the GBU. **About You** + Bachelor's degree in Business, Human Resources, Organizational Development, or related field. + 5+ years of experience in change management or organizational transformation. + Strong knowledge of CMO/CDMO manufacturing - Required. + Strong knowledge of change management frameworks + Demonstrated ability to work in complex, matrixed organizations. + Excellent communication, facilitation, and interpersonal skills. + Proven track record in supporting digital, operational, or organizational transformation programs. + Certification in Change Management or Project Management is a plus. **Key Competencies of a Transformation Leader** As a CMO Business Operations & Transformation Lead, here are the essential competencies that a transformation leader must master: **Vision & Strategy** + Strategic thinking: Ability to see the "big picture" and anticipate trends + Organizational alignment: Connect transformation to business objectives **Change Management** + Change management: Master methodologies + Resistance management: Identify and address barriers to change + Change communication: Adapt messages to different audiences **Operational Competencies** + Project/Program Management + Business acumen with ability to translate transformation into operational impact. + Problem-solving and analytical thinking. + Process optimization: Identify and implement improvements + Digital literacy: Understand emerging technologies (AI, automation, cloud) + Innovation: Promote experimentation and learning **Relational Competencies /Leadership & Influence** + **Cross-functional work: Orchestrate multi-functional teams** + Inspirational leadership: Mobilize and engage teams + Influence without authority: Convince stakeholders at all levels and relationship building at GBU level. + Emotional intelligence: Understand and manage emotions during change change + Negotiation: Find compromises and create consensus **Soft Skills** + **Communication** : Strong communication and facilitation skills (Clarity, active listening, storytelling) + **Empathy** : Understand the human impact of change + **Resilience** and **adaptability** in dynamic environments. **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-SG \#LI-GZ \#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: $147,000.00 - $212,333.33 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 (************************************************

Role: Senior Manufacturing Lead Duration: 6+ Months BGV will be done for the selected candidates. 1) Manufacturing experience in Medical Devices, especially disposable Cardio-Vascular products. 2) Six Sigma certified (Black Belt) 3) Experience in CTQs assessment and translating CTQ into manufacturing specifications 4) Experience in performing gap assessments between design outputs and manufacturing specifications 5) Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality 6) Process Validation - Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) 7) Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all the influencing process parameters 8) Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV) 9) Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes 10) Good experience in Lean manufacturing. Understanding of manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput. 11) Experience in Manufacturing process improvements / Manufacturing yield improvements to improve product quality 12) Good knowledge in Statistics & Minitab 13) Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA 14) Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs Six Sigma (Green belt), Medical Device, Manufacturing, Cardio-vascular, catheter, Process validation, Test Method validation, GD&T, Tolerance analysis, Jigs & Fixture design, Statistics, Minitab, Poka-Yoke, Process development, Process improvement, Value Stream mapping Mandatory Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Poka-Yoke Expert - Process improvement Good - GD&T Good - Tolerance analysis Good - Test Method validation Good - Process validation Good - Cardio-vascular catheter manufacturing process Good Desired Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks Process development Good - Value Stream mapping Good - PFMEA Good - Please respond with your word resume and requested details: Full Name : Work Authorization: Contact Number : Email ID : Skype ID: Current location: Willing to relocate : Rate/hr : Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Manufacturing Manager Title: Manager, Manufacturing Operations Reports to: Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Manufacturing Manager Title: Manager, Manufacturing Operations Reports to : Vice President, PD & Manufacturing Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed. Roles & Responsibilities: Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing. Manage a team of manufacturing technologists, operators, and warehouse coordinators. Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution. Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required. Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs. Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM. Write, review and approve SOP's, qualification protocols, and other GMP documentation. Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients. Implements site initiatives in production operation as advised by site management. Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications. Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports. Responsible for compliance monitoring of area operations. Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues. Process and analyze manufacturing results, data and provide status updates to the management. Establish and maintain positive relationships with project stakeholders. Education, Experience & Skills Required: Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry. Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing. 5+ years of people management experience. Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations. Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable. Ability to perform frequent physical tasks with strength and mobility. Experience in microbiology and sterile manufacturing is a plus. Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

* ABOUT YOU With a primary responsibility of leading contract manufacturing for Bacardi Jacksonville, the External Manufacturing Supervisor will provide strategic support to the business that ensures company goals and objectives are accomplished, in the most cost-efficient manner. Additionally, you they will manage communications between senior leaders and primos and actively liaise with internal and external executives on various projects and tasks related to contract manufacturing. * RESPONSIBILITIES - WITH OUR CONSUMER AT THE HEART, YOUR KEY RESPONSIBILITIES WILL BE TO: External Manufacturing Oversight: * Develop and manage all external manufacturing processes, labor, information, and expenditures * Build and maintain a network of external manufacturing sites that support short- and long-term strategies * Ensure superb customer service and value beyond price Compliance & Standards: * Ensure all external manufacturing sites adhere to Bacardi standards (Quality, GMP, SLA) * Liaise with QEHS for compliance, quality, and corporate responsibilities * Ensure proper cost reporting and adherence to Bacardi financial standards Strategic Projects & Collaboration: * Support global and regional projects with emphasis on external manufacturing * Collaborate with procurement during negotiations and contract preparation * Liaise with Regional Tax and Customs & Excise teams to ensure compliance Process Improvement: * Develop and track KPIs for external manufacturers in support of Bacardi Operating System (BOS) * Drive continuous improvement and lean manufacturing initiatives * Co-lead intra-company and external best practices SKILLS - THE SKILLS AND EXPERIENCE NEEDED TO CREATE YOUR LEGACY: * Minimum 5 years of experience in bottling/packaging (FMCG, food & beverage, pharmaceutical, etc.) * Bachelor's degree in Business or Engineering required; Master's degree preferred * Experience in developing and overseeing budgets * Strong written and verbal communication skills * Excellent time management and ability to coordinate multiple projects * Proficiency in Microsoft Office and aptitude for learning new systems * Ability to maintain confidentiality and operate with integrity PERSONAL QUALITIES: * Leadership: Demonstrates the ability to lead cross-functional teams and external partners with confidence and clarity. * Strategic Thinking: Understands the broader business context and aligns manufacturing strategies with company goals. * Adaptability: Thrives in a fast-paced, dynamic environment and adjusts quickly to changing priorities. * Stakeholder Management: Builds strong relationships with internal and external stakeholders, fostering collaboration and trust. * Problem Solving: Approaches challenges with a proactive mindset and delivers effective, data-driven solutions. * Integrity: Maintains confidentiality and acts with professionalism and ethical responsibility. LEADERSHIP AGILITY At Bacardi we care deeply about finding brilliant talent who can bring the following personal attributes to help elevate our 3Fs: Fearless, Family, Founder culture to the next level. * Belonging: You have a strong capacity to create a culture of 'Belonging', where people feel appreciated for who they are, what they do, and who they can become * Self-Awareness: You have high levels of self-awareness, are reflective and know yourself well, understanding both your own strengths and weaknesses and your impact on others * People Agility: You bring a deep ability to understand and relate to people and navigate through tough situations to harness and multiply collective performance * Results Agility: You demonstrate consistent delivery of results in first-time situations by inspiring teams, exhibiting a presence that builds confidence in yourself and others. * Mental Agility: You can think critically to penetrate complex problems and expand the possibilities by making fresh connections. You think strategically whilst being execution focused and bring creativity to the challenges you're presented with * Change Agility: You have a deep natural curiosity, desire to experiment and ability to effectively deal with the heat of change. You have a growth and learning mindset: ready to test, stumble, learn and apply from experience Disclaimer: Bacardi seeks talent from all backgrounds to bring diversity of thought, agility and capability to our organization across the globe. We promote a working environment where all employees are treated and rewarded fairly. We do not tolerate any form of discrimination that adversely affects individuals or groups on the basis of national origin, race, color, religion, sex, gender, sexual orientation, marital status, disability, age, and any other legally protected aspect of a person's identity. U.S. applicants have rights under Federal Employment Laws. Perks of Working for us At Bacardi, we are committed to providing our Primos (employees) with a comprehensive Total Rewards package of compensation, benefits, incentives, allowances, well-being, and much more to meet the needs of themselves and their families. It goes beyond just Cash! The total rewards program is based on pay for performance, whereby the incentive programs are linked to company and individual performance. Compensation, Paid Time Off & Retirement: * Competitive Pay Package * Competitive Holiday/Paid Time Off, plus additional days offered ( i.e., volunteer day, allowing you to give back to the community) * Retirement/Pension Plan Health & Wellbeing * Medical, Critical Illness, and Life Insurance * Calm Meditation App subscription (free) * Employee Assistance Programs * Best-in-class, family-friendly, and inclusive leave policies Additional Benefits The benefits /perks may vary depending on the nature of your employment with Bacardi, your work location, and are subject to change. Some benefits may be subject to an employee contribution. Some benefits may be fully or partially subsidized. Incentive plans are linked to the nature of your employment and can vary based on region, market, function or brand.

Posted Job Advert The actual location of this job is in Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Join a global team of over 18,000 people making a meaningful difference from day one. As a GMP Manufacturing Supervisor at our Portsmouth site you will coordinate and support production activities for Cell and Gene processes. Find out more about what a life at Lonza in Portsmouth, NH could look like for you by watching this short video. What you'll get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. The full list of our global benefits can be also found on *************************************** What you'll do: Coordinate and support the execution of Cell and Gene production activities, ensuring compliance with ET and site quality systems. Lead and develop the manufacturing team to meet business needs and career goals. Support the timely and complete delivery of clinical and commercial materials. Coordinate various strategies, including EHS, Training, Gowning, Material, Visual Inspection, APS, Cleaning, Scheduling, Financial Management and EM. Maintain manufacturing areas to the highest cleanliness and 6S standards. Support technology transfer activities and ensure timely goal achievement. Establish methods and procedures for attaining specific goals. What we're looking for: BS degree preferred significant experience may be considered in lieu of degree. Minimum 5 years related experience with a degree or 8 years without. Proven experience in biological GMP manufacturing operations. Strong leadership and team development skills. Ability to coordinate complex projects and ensure timely delivery. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their idea, big and small, genuinely improve the world, and that's the kind of work we want to be a part of. The Manufacturing Technical Supervisor will provide a safe, controlled work environment in all areas of responsibility. He or she must be aware of the site safety objectives and make sure they are communicated and understood by all staff. The Manufacturing Technical Manager will act as the Subject Matter Expert in the assigned area (i.e. Cell Growth, Drug Product Filling, etc.) during manufacturing operations until the manufacturing staff is fully proficient. The Manufacturing Technical Supervisor will provide in suite oversight of the manufacturing process during critical operations (i.e. harvest, vial filling, visual inspection, etc.) Work with Internal and Joint Project Teams to bring on and maintain customers' processes in production facility. Responsible for all tech transfers from a manufacturing standpoint. The Manufacturing Technical Manager must attend the lessons learned events for the Cell Therapy (CT) area and own actions for manufacturing. Own and manage planned deviations and change controls related to start-up of Cell Therapy. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with Manufacturing Supervisor(s) to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with Senior Manufacturing Manager to determine equipment and materials the suite will need to purchase in order to run the process. May be required to provide input to Head of Emerging Technology and/or Senior Manager for budgetary/financial planning. May act as fill in for Senior Manufacturing Manager in their absence. Key Responsibilities Support the definition and execution of Operational Readiness Activity for all Emerging Technology projects at Lonza Portsmouth (LPO) to include. Set up of manufacturing procedures & collaboration with Quality Assurance (QA) to develop & execute quality systems aligned with existing operations & finished dose requirements. Support building & establishing the manufacturing team. Delivery of clinical & commercial material as required. Support the development and execution of appropriate Safety, Training, Gowning, Material, Visual Inspection, Cleaning, and Scheduling. Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements. Provide oversight and support to the definition and execution of Technical Transfer activities for Cell Therapy Projects at LPO to include operational input into material requirements, process execution & methods transfer, operational input into defining & executing manufacturing activity related to Technical Transfer - water runs, training runs, particle runs, engineering runs etc. Enable timely delivery of milestones for the Technical Transfer. Coordination with Portsmouth Mammalian Operations and customer technical team. Timely and accurate financial reporting of project progress & revenue status Progression of proposals and change orders. Appropriate interaction with key external (customer) and internal stakeholders. Perform other duties as assigned. Key Requirements Related working knowledge with degree, significant work experience without degree required BS Preferred, additional experience in lieu of degree considered Direct interaction with regulatory agencies Core involvement in Technical Transfer and project activity Leadership of organizational change, staff hiring and training Continuous Improvement activities Generation and optimization of electronic batch documentation Experience of biological manufacturing operations - Fermentation, Purification, Drug Product Filling and Freezing processes. Experience operating automated Drug Product Filling machines using Isolator technology Experience of Autologous / cross training environments requiring innovative resourcing solutions preferred Experience of automated and manual visual inspection systems preferred. Solid staff management experience and proven ability to manage budgets. Ability to work inter-departmentally and potentially with customers. Excellent leadership skills a must. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Join the best radiopharmaceutical company in the world! If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission-advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package. Position The Supervisor, Radiopharmaceutical Manufacturing will be responsible for leading daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role is responsible for delivering all types of batches, including but not limited to clinical and commercial client batches per schedule and contract obligations. This position will lead and mentor a team, efficiently allocate resources, and continuously seek to enhance production processes to optimize operational efficiency. This position plays a key role in maintaining the integrity and safety of the manufacturing environment which is essential for the successful delivery of clinical and commercial radiopharmaceutical products. Responsibilities Manage the day-to-day activities and personnel to ensure efficient manufacturing of products to meet the master production schedule ensuring compliance with regulatory requirements, while maintaining high safety standards. Provide leadership, training, and support to the team. Responsible for the performance of team members and ensuring training requirements are achieved. Monitor and enforce strict quality assurance procedures and key operational metrics to meet the specifications of each product. Address and resolve any issues related to equipment, processes, or personnel in a timely and effective manner with proper communication and/or escalation as needed. Effectively communicate with essential manufacturing support groups to ensure clarity on product specifications, address any escalations promptly, and coordinate delivery schedules. Regularly update management on production status and any critical issues. Responsible to ensure complete and accurate records are maintained for Radiopharmaceutical Manufacturing (Batch Production Record) according to customer and/or Product Development orders. Assist leader in maintaining the department's budget, focusing on the efficient allocation and utilization of resources by monitoring monthly production expenditures. Collaborate with the manufacturing support teams to allocate resources effectively, supporting the technology transfer and process scale-ups in radiopharmaceutical manufacturing to meet business needs and product development goals. Early Development After 3 months, you will: Demonstrate a strong understanding of foundational cGMP requirements and just‑in‑time radiopharmaceutical manufacturing principles, with the ability to guide team members in applying them consistently. Obtain qualification as a Radiation Worker, including training in ALARA principles and isotope‑specific safety protocols, enabling you to model best practices and reinforce a strong safety culture. Build effective working relationships with cross‑functional partners-including Quality, Science, and Engineering-to support operational coordination and ensure timely, compliant delivery of radiopharmaceutical products. Gain expertise with NorthStar's advanced manufacturing systems and processes, preparing you to oversee daily operations and support the development of technical staff. After 6 months, you will: Contribute to Operational Excellence by managing team performance against key KPIs and implementing process improvements that enhance production efficiency, safety, and product quality. Achieve Qualified Operator status and obtain qualifications as a licensed Authorized User, with the capability to oversee and support the team in executing full batch manufacturing of novel isotopes while ensuring adherence to defined regulatory standards and procedures. Develop and lead a high performing organization, positioning yourself as a key leader who drives team capability, fosters continuous improvement, and supports the growth of cutting‑edge manufacturing operations. Fully integrate into NorthStar's mission to transform oncology care, actively supporting a high‑performing team that enables global access to innovative radiopharmaceutical therapies. Qualifications Associate's Degree (AS) in a STEM discipline and minimum four (4) years of cGMP experience; or equivalent combination of education and experience. Minimum one (1) year of experience leading others required. Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9. Shift Information Third shift hours are Monday - Thursday 9pm - 7:30am (shift ends Friday morning). During this position's training period (approximately 60 days), the ability to work alternate shifts is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility. Working occasional overtime, weekends, and holidays is required. Benefits Medical, dental, and vision insurance Healthcare Flex Spending Account (FSA) and Dependent Care FSA Company-paid short-term and long-term disability Company-paid life insurance & AD&D coverage Pet insurance 401(k) match Paid holidays and paid time off (PTO) Paid parental leave Bonus plan Equity Incentive Program Working Conditions This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include: Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors Noise levels range from quiet to loud, depending on the work area Specific vision abilities, including near vision, visual acuity, and color discrimination Personal Protective Equipment (PPE) is required and may include: Respirators, gloves, safety glasses, and full protective clothing Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings) Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to: Follow strict radiation safety procedures Participate in dosimetry monitoring and bioassay testing as part of the company protocol Inform leadership of any health conditions that may affect product integrity, by cleanroom standards Location NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford. Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation. NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.