17 cmc mature products regulatory senior manager jobs found

Biogen About This Role Directly accountable to manage and oversee all meetings and congresses for their assigned business unit(s) internal stakeholders and external stakeholders. As a senior manager, the role is accountable to the most high-touch, complex projects, many of which are working directly with the president of BNA and/or the North American Leadership Team. Their accountability includes and is not limited to understanding the business units, products and all associated environmental factors, incorporate meeting management best practices for both virtual and live meetings or congresses and to be in compliance with all Biogen corporate, financial, legal, and regulatory and travel policies and controls. This knowledge will better support their ability to execute strategic meeting management elements to reduce overall meeting cost while improving the stakeholder (both meeting host and participant) experience. The senior manager will also mentor and train meeting and...

Who we are Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients, and we've built a promising pipeline centered around our core therapeutic areas which include neuroscience, immunology, and immuno-oncology. We are continually developing patient-centric solutions and significantly growing both our generic, biosimilar, and innovative medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! The opportunity As one of the key leadership roles...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch....

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes but is not limited to the...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity Teva’s Global R&D division develops new medicines, devices, and combination products to benefit patients worldwide. Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Biogen About this role Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives. We apply a deep understanding of human biology and leverage different therapeutic modalities to advance first-in-class treatments or therapies that deliver superior outcomes to patients. We are looking for a motivated and passionate individual to join us as a Director, Development Toxicology, with a focus on enabling the delivery of transformative and safe drugs to patients. You will provide non-clinical safety expertise for our diverse portfolio which contains a broad range of indications and drug modalities. This high-impact role supports the advancement of the pipeline by designing, conducting and interpreting toxicology studies, assessing safety risks, and contributing to project strategy across all phases of Drug Development and for our marketed products. The position is based in a collaborative, multidisciplinary...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Alkermes, Inc. The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and is a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. The Principal Scientist works within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities Responsibilities: Serve as the primary Analytical Development representative on CMC teams, translate program objectives into phaseappropriate analytical strategies, plans, and timelines. Provide strategic CDMO oversight for analytical activities, which may include product...

Lantheus Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team....

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Point32Health, Inc. Who We Are Point32Health is a leading not-for-profit health and well-being organization dedicated to delivering high-quality, affordable healthcare. Serving nearly 2 million members, Point32Health builds on the legacy of Harvard Pilgrim Health Care and Tufts Health Plan to provide access to care and empower healthier lives for everyone. Our culture revolves around being a community of care and having shared values that guide our behaviors and decisions. We've had a long-standing commitment to inclusion and equal healthcare access and outcomes, regardless of background; it's at the core of who we are. We value the rich mix of backgrounds, perspectives, and experiences of all of our colleagues, which helps us to provide service with empathy and better understand and meet the needs of the communities where we serve, live, and work. We enjoy the important work we do every day in service to our members, partners, colleagues and communities. Learn more about...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development...