53 specialist contract development manufacturing jobs found

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist, Contract Development & Manufacturing at Amgen provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. Working within a diverse Commercialisation & Performance Execution (CPE) team, this role works in partnership with different departments & stakeholders to ensure a smooth manufacturing process and compliance with quality standards. The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluate options and solutions; drive precision through the execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge...

Career Category Supply Chain Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for...

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist Contract Development & Manufacturing at Amgen provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.  They provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. In this dynamic role, you will provide a strategic dimension to Amgen's manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. Responsibilities: Project Management and Technology transfers: The role involves leading and...

I&I Gastroenterology Health Science Specialist - Charlotte, NC ROLE SUMMARY Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring...

I&I Gastroenterology Health Science Specialist - Columbus, OH ROLE SUMMARY Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies...

I&I Gastroenterology Health Science Specialist - Cincinnati, OH ROLE SUMMARY Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring...

ROLE SUMMARY  Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.  The...

Job Description Summary The Clinical Specialist is a resource for the execution of the Medication Delivery Solutions value-added clinical business strategy. The role implements clinical programs and initiatives that differentiate the MDS product portfolio based on improved clinical outcomes and process enhancements which may result in a lower cost-in-use. The expertise and credentials of the Clinical Specialist enhances the credibility of recommendations to customers and strengthens customer service and support. This support to customers is achieved through recommending best practice and facilitating education. The Clinical Specialist actively engages in conversion management, product implementation and training of Medication Delivery Solutions products. The Clinical Specialist reports directly to a Clinical Manager. Works primarily in a geographically defined territory; however, based on clinical needs, could assist outside of the region. Job Description We are the...

Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.   Global Reach with a Local Touch 140+ years serving healthcare Over 14,000 teammates worldwide Serving healthcare partners in 80 countries Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland 40+ distribution centers Portfolio of 300 propriety and branded product offerings 1,000 branded medical product suppliers 4,000 healthcare partners served   Benefits...

Job Description Summary Job Description We are the makers of possible    BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.  Davol Inc./C.R. Bard has joined BD. BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have...

Job Description Summary Job Description We are the makers of possible    BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.    We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.  BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in...

Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.   Global Reach with a Local Touch 140+ years serving healthcare Over 14,000 teammates worldwide Serving healthcare partners in 80 countries Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland 40+ distribution centers Portfolio of 300 propriety and branded product offerings 1,000 branded medical product suppliers 4,000 healthcare partners served   Benefits...

Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. This is a 12-month temporary contract As a QC Micro Specialist, a typical day might include, but is not limited to, the following: Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures, becoming the SMEs of these technologies, assays, and procedures Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed...

Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions. This position would focus on initial commercial applications, completing the CMC aspects (e.g., Module 3) of submission content.   As a Staff CMC Regulatory Sciences Specialist. a typical day might include the following: Develop processes and tools for the preparation of global marketing applications & support the development and execution of CMC regulatory strategies for global markets. Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local regulations and guidelines. Develop and maintain relationships with cross functional teams, contract manufacturing organizations, as well as global regulatory partners....

The QA Specialist/Sr QA Specialist for External Drug Product Manufacture provides QA oversight to ensure that drug product manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following:   Reviewing and approving the following document types, relating to area functions: Master records, Executed records, Failure investigations, Change Control & Partner Notifications, Standard Operating Procedure (SOPs) Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Providing governance/performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Representing Quality Assurance both internal to Regeneron and External with Partners and Contract Manufacturers in...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. Regeneron leads with science and our global procurement team will play a critical role in enabling our scientific advancements. Our vision is to build a procurement capability that acts as a competitive advantage to Regeneron. This is a phenomenal opportunity to join us and help to craft and drive the development of the new organization and realize our vision. The Global Procurement team will be structured with category teams having end to end accountability for category management, sourcing, contracting, and supplier relationship management for assigned...

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. Regeneron leads with science and our global procurement team will play a critical role in enabling our scientific advancements. Our vision is to build a procurement capability that acts as a competitive advantage to Regeneron. This is a phenomenal opportunity to join us and help to craft and drive the development of the new organization and realize our vision. The Global Procurement team will be structured with category teams having end to end accountability for category management, sourcing, contracting, and supplier relationship management for assigned...