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

About the Department Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. The Position The Technical Team Lead, API Manufacturing works in Novo Nordisk's Boulder, Clinical Pilot Plant and is responsible for the production of GMP oligonucleotide API to support toxicology studies. In addition to ensuring the supply of API and meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk and cost to the overall operation. Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager, API Manufacturing. The Technical Team Lead works with Chemical Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions + Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory, and business processes and/or procedures + Commission, operate, maintain, and troubleshoot pilot plant equipment such as oligonucleotide synthesizers, purification systems, lyophilizers, and analytical instrumentation + In collaboration with Chemical Development, transfer and scale-up processes from laboratory to pilot plant scale + Author and/or review batch documentation (data capture forms, solution preparation forms, work instructions, etc.) and generate automated equipment methods + Execute manufacturing schedule to achieve manufacturing goals + Safely handle hazardous materials/waste including organic solvents, strong acids and bases + Lead troubleshooting efforts for process and equipment issues; develop and implement corrective actions + Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis + Support the technology transfer of manufacturing processes into Phase I/II cGMP Manufacturing Facilities + Responsible for routine communication to all levels of the organization on manufacturing activity + Support equipment calibration and maintenance programs + Provides training, technical mentorship, scientific guidance, and peer leadership to junior staff Physical Requirements Ability to sit, stand, reach, bend, climb, balance, walk, and finger. Ability to lift up to 50lbs of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Visual acuity to determine accuracy, neatness, and thoroughness of work and to make general observations. Qualifications + Bachelor's degree in Life Science, Chemistry, or Engineering with at least eight (8) years of relevant experience; a Master's Degree in Life Science, Chemistry, or Engineering with at least six (6) years of relevant experience; or twelve (12) years of relevant experience with a High School diploma is required + Strong background in oligonucleotide-based drug substance development and manufacturing including knowledge of nucleic acid synthesis, purification, ultrafiltration, annealing and lyophilization techniques and equipment is highly desired + Requires a proficient understanding of cGXP and applicable regulations and guidelines + Working knowledge of control software for automated oligonucleotide synthesizers and/or chromatography systems is highly desired + Mechanical aptitude with ability to use tools to perform tasks, basic troubleshooting of mechanical components and systems + Ability to work independently and within teams that consist of members with different degrees of knowledge or ability + Possess excellent written and verbal communication skills + Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities + Basic computer literacy including, but not limited the use of MS Office suite programs (Word, Excel, Outlook) + Familiarity with the transfer and scale-up of development processes to the manufacturing scale is preferred + Experience with new plant startup and operation is desired Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process. The base compensation range for this position is $96,670 to $178,840. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at **************. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Supply Chain Manufacturing **Job Sub** **Function:** Manufacturing Assembly **Job Category:** Business Enablement/Support **All Job Posting Locations:** Jacksonville, Florida, United States of America **Job Description:** Johnson & Johnson is recruiting a **Manufacturing Technical Lead (Technician V)** , to join our Vision team in Jacksonville, FL. **About Vision** Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech **Purpose:** Our Manufacturing Technicians are on the front line of innovative technology. They are responsible for the safe operations of our fully automated production line performing all responsibilities vital to operate, adjust, and maintain equipment. Investigate alternative methods and procedures to reduce variability and improve equipment reliability. Abide to manufacturing guidelines, policies, and operations run rules. Maintains compliance in safety, quality, and production. Complete all performance and development activities. Demonstrates behaviors consistent with Johnson and Johnson Standards of Leadership. **Key Responsibilities:** + Advanced level position qualified on designated generation line qualification. + Assumes responsibility for performance of designated generation to meet safety, quality, and production targets. + Performs root cause analysis on manufacturing lines not meeting production targets and provides mentorship on how to improve line performance. + Coordinates and provides line management coaching and technical skill development for team. + Develop and present training material based on generation needs. + Coordinates safety, quality and production escalations as needed. + Attend meetings as needed to report production escalations or results. + Provide support for cross-functional teams to develop equipment and/or process improvements to improve efficiency, product yield, and equipment reliability. + Acts as an advocate for continuous process and technology improvement while working closely with function group teams when troubleshooting the equipment and processes. + Works with Manufacturing Supervisors to assign line assignments every shift. + May cover the role of a technician and needs to meet their requirements. + Qualified in Johnson and Johnson electrical safety certification. **Qualifications** **Education:** + A High school diploma is required, associate degree or, equivalent highly preferred. **Experience and Skills:** **Required:** + A minimum of six (6) years of relevant technical/vocational shown experience required. + Johnson and Johnson electrical safety certification. + This position will require to complete Ramsay Mechanical Proficiency Test + Ability to prioritize projects, tasks and handle multiple tasks. + Proficient interpersonal skills, both written and verbal required. + Shift lead experience in a manufacturing environment. + Detailed knowledge on electrical fundamentals and safety, including cabinet entry procedures, boundaries, and PPE (Personal Protective Equipment) requirements. + Physical demands of the position include stooping, walking, pulling, light lifting (up to 25 lbs.), grasping, hearing, visual acuity, kneeling, reaching, pushing, talking, standing, and crawling. + Ability to work rotating 12-hour shifts, 6pm to 6am or 6am to 6pm, including weekends, on a regular basis required. **Preferred:** + At least (8) years of college, trade, or military training in a technical field or, equivalent industrial experience emphasizing electro-mechanical, PLC, and pneumatics highly preferred. + Proven understanding and solving skills in the following areas preferred: Process Improvement, Programmable Logic Controller (PLC) systems, electro/mechanical devices, robotic/servo systems, safety devices, equipment installation, debug and qualification, control circuitry development, electro-mechanical solving/repair, equipment prototyping, production start-up, equipment process development and mechanical devices, controller, mechanical part's design, tooling experience, electrical & mechanical prints. + Operations management experience with excellent communication, interpersonal and organizational skills. + Mechanical and electrical experience in equipment development, project management, construction, installation, and qualification. + Phenomenal understanding of the term associated and purpose of Lean Six Sigma. Proficient with utilizing the principles in reducing process variations. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:**

Do you have manufacturing production management experience? Timpte is looking for a Director of Manufacturing to drive innovation and excellence for our Brand New Lincoln Manufacturing Center location. This role will direct and oversee the manufacturing activities, lead and execute strategic plans and processes, and coordinate resources to create world class quality products in conjunction with Timpte Production System. Ensure manufacturing performance and quality goals are met and standards are upheld. Pay for this position is up to $160k/year (Depending upon experience) + annual bonus!! Primary Responsibilities: Safety, Quality, On-time Completion, and Product cost (labor/overhead) as it relates to the manufacturing cycle of our products. Directly supervise and manage the manufacturing team in the planning, development, and execution of both strategic initiatives and day to day business activities. Establish key strategies within the manufacturing environment that align and support the overall company mission. Qualifications: Must possess a bachelor's degree applicable to the position and have 5-10 years' experience in manufacturing production management. Excellent communication skills, both verbal and written as well as presentation skills. Must have a complete understanding of all production processes. Must have a “customer service” focus. Must be able to lead and collaborate with different departments within the organization. Must be proficient or have working knowledge in Microsoft Office programs, including Word, Excel, etc. Must be able to maintain confidentiality of proprietary information. Personal Attributes: You are a highly motivated, result-oriented self-starter, and can deliver successful results with minimal guidance High energy and enthusiasm, with a strong commitment to exceeding company expectations Ability to learn quickly, make an immediate impact, and provide value added service to our clients, customers, and vendors Flexibility and openness to work on a variety of assignments Leadership, and a willingness to take responsibility and accountability Timpte Excellent Benefits: Competitive salary with bonuses! Benefits- medical, dental, vision plans 401K with company match Paid Holidays, Generous Paid Time Off And More!

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 (************************************************

Core Hours Sunday - Wednesday, 5:00 pm - 5:30 am; every other Wednesday off Purpose and Scope The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients. Key Responsibilities Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time". Perform job in a clean room environment requiring clean room gowning, including but not limited to: Company-provided Scrubs Shoe Covers and Sterile Boot Covers Hairnets (and beard covers as applicable) Tyvek Coveralls Gloves Full-face masks/hoods Goggles Chemical Protection PPE Setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records. Set-up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas. Perform routine sampling and inspections of pre-filled syringes for injectable products. Set-up and operate compounding equipment used to produce bulk material for injectable products. Perform biological sampling of general manufacturing clean room facilities. Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes. Document production activities using regulatory controlled documents including production records and log books. Accurately perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures. Perform visual and physical inspections of in-process and finished product as requested. Responsible for assembly, disassembly and sanitation of various equipment. Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records. Responsible for quality of product. Train other Aseptic Operators and Technicians in the Injectable Products team to perform job duties related to their position. Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies. Formulate bulk materials. Maintain proper use of aseptic techniques. Operate under the minimal supervision of a Supervisor. Perform other duties as assigned. Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP). Ability to stand for extended periods of time (up to 8 hours or more). Proficient in Microsoft Office (Excel, Word, Outlook). Ability to maintain focus on detail-oriented, repetitive tasks. Excellent verbal and written communication skills to interact with Supervisors and colleagues. Adhere to written production records and validation protocols. Strong math and writing skills to document production activities in batch records and/or log books. Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements. Capability to operate on a fast-paced manual assembly line using basic production equipment. Ability to legibly complete required documentation. Core Values This position is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​ Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​ Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. ​Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​ Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Communication Interact with peers and members of other departments in team settings in a professional manner. Provide consistent coaching, guidance, development and mentorship to operators. Education & Experience High school diploma or equivalent required. 3 or more years of experience in a GMP manufacturing environment. Additional Requirements Acceptable results on both a quantitative and verbal assessment test. Valid driver's license and acceptable motor vehicle record may be required. Shift work in a manufacturing and warehouse environment. May require overtime. Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type. Compensation and Benefits Pay: $31.28 per hour Shift Differential: $2.50 Bonus Eligible Benefits summary: https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

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.

We are seeking a strategic and hands-on Director, HR Business Partner to support one or more sub-functions within the Biopharmaceutical Sciences & Manufacturing Organization (BSMO) during a pivotal phase of growth and innovation. In this role, you will be a visible HR leader within the sub-function, serving as a trusted advisor to senior leaders and their teams. You will shape the people and organization strategy, enable business outcomes, and foster a high-performance, agile culture across a regulated manufacturing and technical development environment. This is a senior individual contributor role that leads through influence-orchestrating outcomes across a matrix, aligning cross-functional stakeholders, and leveraging specialist HR centers of excellence to deliver integrated solutions. Key Duties and Responsibilities: Strategic HR & Business Partnership * Serve as the primary HR partner to one or more senior leaders for assigned BSMO sub-function(s); translate business strategy into a prioritized, integrated people and organization plan. * Influence executive decision-making through clear options, risk/benefit tradeoffs, and data-backed recommendations that connect talent levers to operational, quality, and cost outcomes. Organization Design, Capability, & Operating Model * Lead org design and evolution for growth, complexity, and scale (e.g., standing up new capabilities, optimizing spans/layers, clarifying interfaces and governance). * Define and build critical capabilities, partnering with leaders to close skill gaps via targeted build/buy/borrow strategies. Strategic Workforce Planning (SWP) & Succession * Own the sub-function's multi-year workforce plan aligned to long-range strategy, capacity, and budget-headcount, skills, pipeline, and location strategy. Ensure the plan aligns to the broader enterprise level plans for BSMO and Vertex. * Drive succession readiness for pivotal roles; develop diverse slates and growth plans that ensure continuity for GMP operations and technical/scientific leadership. Talent, Performance, & Leadership Effectiveness * Elevate leadership performance at the senior levels and with their teams: build management routines, coach through inflection points, and raise the performance bar with clarity and fairness. * Partner with Talent Management to deploy targeted programs (e.g., high-potential acceleration, career pathways, technical leadership tracks). Culture, Engagement, & Change Leadership * Diagnose and shift culture in alignment with BSMO strategic culture roadmap and steward change for network expansions, tech transfers, or portfolio pivots. * Design and execute change plans (case for change, stakeholder maps, comms, adoption metrics) across multi-site and cross-functional contexts. People Analytics & Insights * Leverage data to illuminate trends (e.g., attrition risk in critical skills, shift staffing dynamics, succession health). * Convert insights into simple, compelling narratives that build alignment and prompt action; measure impact and iterate. HR Operating Model & Governance * Orchestrate with Total Rewards, Talent Acquisition, People Experience, Talent Management, and Strategic Analytics to deliver integrated solutions at pace. * Ensure flawless execution of core cycles (performance, calibration, compensation planning) with equity, transparency, and business relevance. Knowledge and Skills: * Experience developing and implementing HR strategies * Expert-level experience developing strategic workforce plans, from conception to implementation * Highly experienced in talent management, succession planning, and career growth and development * Strong experience managing and/or leading culture and change management or organizational effectiveness initiatives * Experience and expert understanding of management development, employee relations, data and analytics, diversity and inclusion Education and Experience: * Bachelor's degree or equivalent in management, human resources, business, or related discipline. * 10+ years of progressive HR experience, including HRBP leadership in a regulated manufacturing environment (biotech/pharma strongly preferred). * Demonstrated impact partnering with senior-level clients in complex, matrixed organizations; proven ability to lead without direct authority. * Expertise in organization design, strategic workforce planning, succession, and talent management, with experience in technical/manufacturing populations preferred. * Fluency with people data and financial/budget trade-offs; able to link talent decisions to operational, quality, safety, and cost outcomes. * Depth in change leadership and organizational effectiveness with measurable results in high-stakes, time-bound transformations. * Experience across GMP manufacturing and technical development (e.g., MS&T, process development, QA/QC, supply/tech transfer) and partnering with site and network leaders. * Track record building capabilities at scale (e.g., new modalities, network expansion, digital/automation in labs/plants). * Exposure to global or multi-site contexts; comfort operating across time zones and cross-functional leadership teams. #LI-EE1 #LI-Hybrid Pay Range: $185,600 - $278,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

**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.

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.

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.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Current Shift Needs: Graveyard shift: 10:00 pm to 6:30 am - Monday through Friday Potentially work 7:00 am to 4:00 pm for the first month or two. POSITION SUMMARY The Supervisor, Manufacturing, oversees the manufacturing process and the department personnel on designated shift to ensure process meets cGMP (current Good Manufacturing Practices) and company standards for an aseptic operation. Trains and develops department technicians. ESSENTIAL DUTIES & RESPONSIBILITIES may include the following. Other duties may be assigned. Provides immediate supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. Oversee production review of all department batch documentation for completeness and accuracy. Initiate Facility Work Orders when equipment requires repair. Participate in process/product troubleshooting in order to correct/maintain aseptic processing and desirable product yields, as well as environmental control of facility. Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product. Maintain a quality presence to ensure compliance with all regulatory requirements. Maintain current knowledge of regulatory and industry standards. Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility. Provide guidance and hands-on training to direct reports. Appraise and monitor performance of department personnel. Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources. Provide a leadership role ensuring employee health and safety. Involved in interviewing/selection process of hiring or promoting department personnel. REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. * Associate's degree required. Bachelor's degree preferred. Emphasis in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred. * Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. * Equivalency: In lieu of an Associate's degree, candidate must have a High school diploma or GED, and a minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. * Requires an in depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing. * Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines. * Prior supervisory or leadership experience is highly preferred. * Demonstrated ability to inspire high performance in others and align team members around shared goals. * Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel. * Demonstrated project management skills. * Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. * Must be proactive, results oriented, and have strong attention to detail. * Self-starter with strong work ethic and the ability to exercise good judgment. * Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. * Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. * Excellent verbal and written communication skills in the English language. * Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). * Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7-day plant operation. Occupational Demands: Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Operate power equipment. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32* and on occasion, exposure to extreme heat above 100*. Exposure to vibration or oscillating movements of the extremities or the whole body. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Walks on uneven ground. Personal protective equipment required such as: protective eyewear, face shields, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Heavy lifting and carrying of 50lbs. for up to 6-8 hours per day, with a maximum lift of 75lbs. Work is performed standing, walking, bending and twisting waist for 4-6 hours per day. Frequent foot movements. Occasionally reaches above and below shoulder height. Occasionally bends and twists neck. Frequent hand movements with simple grasping of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs a wide range of complex tasks. Adheres to a work schedule to meet production standards. The estimated pay scale for the Supervisor, Manufacturing role based in Los Angeles, CA starts at $90,000 -$98,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 8% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! * This is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Current Shift Needs:** Graveyard shift: 10:00 pm to 6:30 am - Monday through Friday Potentially work 7:00 am to 4:00 pm for the first month or two. **POSITION SUMMARY** The Supervisor, Manufacturing, oversees the manufacturing process and the department personnel on designated shift to ensure process meets cGMP (current Good Manufacturing Practices) and company standards for an aseptic operation. Trains and develops department technicians. **ESSENTIAL DUTIES & RESPONSIBILITIES may include the following. Other duties may be assigned.** Provides immediate supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules. Oversee production review of all department batch documentation for completeness and accuracy. Initiate Facility Work Orders when equipment requires repair. Participate in process/product troubleshooting in order to correct/maintain aseptic processing and desirable product yields, as well as environmental control of facility. Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product. Maintain a quality presence to ensure compliance with all regulatory requirements. Maintain current knowledge of regulatory and industry standards. Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility. Provide guidance and hands-on training to direct reports. Appraise and monitor performance of department personnel. Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources. Provide a leadership role ensuring employee health and safety. Involved in interviewing/selection process of hiring or promoting department personnel. **REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. + Associate's degree required. Bachelor's degree preferred. Emphasis in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred. + Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Equivalency: In lieu of an Associate's degree, candidate must have a High school diploma or GED, and a minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. + Requires an in depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing. + Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines. + Prior supervisory or leadership experience is highly preferred. + Demonstrated ability to inspire high performance in others and align team members around shared goals. + Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel. + Demonstrated project management skills. + Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. + Must be proactive, results oriented, and have strong attention to detail. + Self-starter with strong work ethic and the ability to exercise good judgment. + Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. + Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. + Excellent verbal and written communication skills in the English language. + Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). + Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7-day plant operation. **Occupational Demands:** Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Operate power equipment. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32* and on occasion, exposure to extreme heat above 100*. Exposure to vibration or oscillating movements of the extremities or the whole body. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Walks on uneven ground. Personal protective equipment required such as: protective eyewear, face shields, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Heavy lifting and carrying of 50lbs. for up to 6-8 hours per day, with a maximum lift of 75lbs. Work is performed standing, walking, bending and twisting waist for 4-6 hours per day. Frequent foot movements. Occasionally reaches above and below shoulder height. Occasionally bends and twists neck. Frequent hand movements with simple grasping of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs a wide range of complex tasks. Adheres to a work schedule to meet production standards. The estimated pay scale for the Supervisor, Manufacturing role based in Los Angeles, CA starts at $90,000 -$98,000 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 8% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! *This is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA** Learn more about Grifols (************************************** **Req ID:** 536371 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Job Title: Manufacturing Supervisor Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies. What We Offer: · Competitive Pay o Salary Range: $75,000.00 - $90,000.00 o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. · Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs · Career Growth What You'll Do: · Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production · Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures · Oversee mixing of raw materials according to formulation specifications and batch records · Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits · Maintain accurate and complete records of production, materials, and quality control checks · Schedule and assign work to meet daily and weekly manufacturing targets · Support troubleshooting of equipment and process issues, and implement corrective actions · Coordinate preventative maintenance and calibration of departmental equipment · Collaborate with internal teams including Quality, Project Management, and Maintenance · Assist in performance evaluations, disciplinary actions, and interviewing new team members · Participate in developing, reviewing, and editing departmental SOPs and procedures · Promote a culture of safety, accountability, and continuous improvement What We're Looking For: · High school diploma or GED required · Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred · Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices · Excellent communication and leadership skills with the ability to train, motivate, and supervise staff · Proficiency in basic math and computer software including Microsoft Office · Mechanical aptitude and ability to safely operate forklifts and pallet movers · Able to work different shifts or overtime to meet manufacturing needs · Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today! #INDOTHER2025

Job Description Job Title: Manufacturing Supervisor Hours: 2nd shift, Monday-Friday, 3:00pm-11:30pm Join Our Team: At Accupac, we are Makers. From formulation to manufacturing, we serve the most trusted brands in the beauty and personal care industries with a wide range of cosmetics, over-the-counter and medical devices across skincare, haircare, oral care, and healthcare products. But beyond that, we make a difference. We make a difference in the lives of our people, we make a difference in the community around us, we make a difference in the health of our planet for a better, brighter, more beautiful future for all. We value safety-minded, detail-driven leaders who thrive in a fast-paced manufacturing environment and bring strong organizational and people management skills to production operations. As a Manufacturing Supervisor, you'll oversee the preparation, mixing, and production of high-quality products while ensuring all compounding processes meet safety, efficiency, and compliance standards in accordance with cGMPs, regulatory requirements, and company policies. What We Offer: · Competitive Pay o Salary Range: $75,000.00 - $90,000.00 o Bonus: Exempt employees are eligible for a bonus in accordance with Accupac's Bonus Plan o The posted job may span more than one career level. The final offer, including level and pay, will be determined based on a variety of factors such as the candidate's relevant job and industry experience, education, knowledge, skills, geographic location, and abilities. Internal equity and alignment with market data will also be considered. We are committed to providing fair and competitive compensation based on each candidate's qualifications and fit for the role. · Employees are eligible for the following benefits: o Medical, Dental, and Vision insurance o Health Savings Account o Life Insurance with Optional Supplemental Plan o Pet Insurance o Short-Term Paid Disability o 401(k) Retirement Plan with Vested Company Match Contribution o Paid Time Off (PTO) o 10 Paid Holidays o Health Advocacy Programs · Career Growth What You'll Do: · Supervise and lead the compounding team in day-to-day operations, ensuring safe and efficient production · Train staff on SOPs, GMPs, safety protocols, and customer-specific procedures · Oversee mixing of raw materials according to formulation specifications and batch records · Ensure compliance with cGMP, FDA, and internal quality standards through regular inspections and audits · Maintain accurate and complete records of production, materials, and quality control checks · Schedule and assign work to meet daily and weekly manufacturing targets · Support troubleshooting of equipment and process issues, and implement corrective actions · Coordinate preventative maintenance and calibration of departmental equipment · Collaborate with internal teams including Quality, Project Management, and Maintenance · Assist in performance evaluations, disciplinary actions, and interviewing new team members · Participate in developing, reviewing, and editing departmental SOPs and procedures · Promote a culture of safety, accountability, and continuous improvement What We're Looking For: · High school diploma or GED required · Minimum 5 years of experience in manufacturing, with prior supervisory experience preferred · Strong knowledge of cGMPs, FDA regulations, and manufacturing best practices · Excellent communication and leadership skills with the ability to train, motivate, and supervise staff · Proficiency in basic math and computer software including Microsoft Office · Mechanical aptitude and ability to safely operate forklifts and pallet movers · Able to work different shifts or overtime to meet manufacturing needs Must meet physical requirements: lift/carry up to 50 lbs, perform repetitive tasks, stand/walk on concrete floors, work in dusty environments, and wear required PPE including respirators Ready to Apply? Join us at Accupac and become part of a company that values your skills and dedication. Click below to apply today! #INDOTHER2025

Today, Lonza is a global leader in life sciences operating across three 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. Lead Operator, GMP Manufacturing is responsible for direct oversight of staff operations on behalf of the Shift Supervisor of all GMP clinical manufacturing, GMP commercial manufacturing and packaging operations assigned. Lead Operator is responsible for ensuring that all projects assigned are executed in a compliant and efficient manner. Lead Operator is responsible for leading the personnel assigned to their unit. They are intimately involved with the technical aspects of all assigned projects per direct supervision and ensure that their unit works across the entire organization to facilitate the successful development and completion of all projects, which ultimately meets the objectives and goals of Lonza. Key Accountabilities: Able to perform all tasks associated with Operators l, ll and lll. Help organize workflow for assigned unit and delegate tasks to team members. Communicate with direct supervision regarding goals, targets, deadlines and plans accordingly to accomplish tasks and bring projects to completion. Lead, train and advise personnel as applicable. Represent Management as “Designee” for process-related signatory duties. Peer review executed batch records for completeness and clarity. Perform and or assign equipment set-up and daily checks to support the manufacturing operation. Interact with client representatives as necessary to address project needs. Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required. Participate in and recommend staff hiring. Provide recommendations for staff changes and improvement. Execute batch record instructions and oversight of team execution (including but not limited to: dispensing, operating equipment, testing, inspection, packaging as required, general support of the manufacturing operation in any capacity.) Work cross-functionally with supervision, QAU, PM, Technical Services (Mfg. Technical Specialists, Purchaser, Planner, Equipment & Instrumentation Engineer, Process Engineer, Validation Engineer), PDS, EHS, WH, etc. to achieve goals of the team and organization. Key Requirements: A high school diploma required. A minimum of 5 years of experience as a leader or in a management position is required. Pharma cGMP Experience is required. 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.

Tris Pharma, Inc. (******************* is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a Manufacturing Supervisor on 3rd shift. Hours are 10:00 PM - 6:00 AM ESSENTIAL FUNCTIONS: * Accomplishes manufacturing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching and counseling employees; initiating, coordinating, and enforcing systems, policies, and procedures; Provides guidance, support and direction through positive interactions with manufacturing associates during daily operations * Organizes the daily schedule and assigns personnel to the various workspaces to meet the demand of planning * Works collectively with the other Supervisors to assist in setting up the daily schedule and providing coverage for absenteeism * Assures that all Drug Enforcement Agency (DEA) requirements are being followed with respect to the production of controlled substances * Reports and investigates any deviations from processes or procedures * Maintains a presence on the production floor at all times; Trains new employees and mentors lower level technicians as appropriate * Assists with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures * Possesses total comprehension and working knowledge of the manufacturing equipment and manufacturing processes in designated areas * Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment and resources; maintaining compliance with established policies and procedures * Issues work orders, as required * Works extra hours or weekends as required by management to meet the demands of the schedule Requirements QUALIFICATIONS REQUIRED High School diploma or equivalent AND minimum 10 years related work experience OR Associates degree AND 7 years related work experience OR Bachelors degree AND minimum 5 years related work experience. Related work experience must include multiple aspects of the manufacturing process in a pharmaceutical or biotechnology cGMP regulated environment * Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes * Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs * Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. * Strong record keeping skills * Prior pharmaceutical manufacturing group lead or supervisory experience * Ability to train, motivate, direct and supervise manufacturing personnel * Proficiency with Microsoft Office Anticipated salary range: $80,000 to $95,000/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

Tris Pharma, Inc. (******************* is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a Manufacturing Supervisor on 3rd shift. Hours are 10:00 PM - 6:00 AM ESSENTIAL FUNCTIONS: · Accomplishes manufacturing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching and counseling employees; initiating, coordinating, and enforcing systems, policies, and procedures; Provides guidance, support and direction through positive interactions with manufacturing associates during daily operations · Organizes the daily schedule and assigns personnel to the various workspaces to meet the demand of planning · Works collectively with the other Supervisors to assist in setting up the daily schedule and providing coverage for absenteeism · Assures that all Drug Enforcement Agency (DEA) requirements are being followed with respect to the production of controlled substances · Reports and investigates any deviations from processes or procedures · Maintains a presence on the production floor at all times; Trains new employees and mentors lower level technicians as appropriate · Assists with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures · Possesses total comprehension and working knowledge of the manufacturing equipment and manufacturing processes in designated areas · Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment and resources; maintaining compliance with established policies and procedures · Issues work orders, as required · Works extra hours or weekends as required by management to meet the demands of the schedule Requirements QUALIFICATIONS REQUIRED High School diploma or equivalent AND minimum 10 years related work experience OR Associates degree AND 7 years related work experience OR Bachelors degree AND minimum 5 years related work experience. Related work experience must include multiple aspects of the manufacturing process in a pharmaceutical or biotechnology cGMP regulated environment · Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes · Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs · Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. · Strong record keeping skills · Prior pharmaceutical manufacturing group lead or supervisory experience · Ability to train, motivate, direct and supervise manufacturing personnel · Proficiency with Microsoft Office Anticipated salary range: $80,000 to $95,000/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity. Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups. Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.