Aktuelle Jobs im Zusammenhang mit Associate Director, External Manufacturing Biologics, Tech Transfer - Boudry - Bristol-Myers Squibb
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Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy Quality Assurance team in a key role that will drive the quality of our external drug product manufacturing...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy QA External Drug Product Quality team.About the RoleThis is a unique opportunity to work in a cross-functional team,...
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Associate Director Cell Therapy QA External Drug
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Associate Director Cell Therapy QA External Drug
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Principal Scientist Ms&t Ds Exm
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Associate Director, Business Process Optimization
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Principal Scientist
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Senior Quality Assurance Manager
vor 2 Monaten
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleWe are seeking a highly skilled and experienced Senior Manager to join our Cell Therapy team at Bristol Myers Squibb. As a key member of our External Quality Assurance team, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy manufacturing.Key ResponsibilitiesOversee and...
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Associate Director, Biologics Long-term Supply and
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Associate Director, Business Process Optimization
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Associate Director, Supplier Relationship Manager
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleThe Associate Director, Business Process Optimization and Systems is a key member of the Cell Therapy External Manufacturing (ExM) organization, reporting to the Sr. Director Global Business Process & Supplier Digital Strategy. This role is responsible for driving business process improvement initiatives via global cross-functional teams, with...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryWe are seeking a highly skilled Senior Manager to join our Cell Therapy team as External Drug Product Quality Assurance. This is a key role that will be responsible for overseeing and controlling operational tasks performed by external partners involved in Cell Therapy (CAR-T) manufacturing.Key ResponsibilitiesOversee and control operational tasks...
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Senior Quality Assurance Director Cell Therapy
vor 2 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleBristol Myers Squibb is seeking a highly skilled and experienced Quality Assurance professional to join our Cell Therapy team as a Senior Quality Assurance Director Cell Therapy. This is an exciting opportunity to work on a global scale and be part of a team that is transforming the lives of patients through science.Key ResponsibilitiesProvide...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryBristol Myers Squibb is seeking a highly skilled Quality Assurance Manager to join our Cell Therapy team. As a Quality Assurance Manager, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for commercial and clinical CAR T products in Europe.Key...
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Associate Director, Network Supply Planning
Vor 3 Tagen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Director, Quality Operations
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Vice President, Cell Therapy External Manufacturing
vor 5 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryWe are seeking a highly skilled Senior Manager to join our Cell Therapy QA team. As a key member of our organization, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy manufacturing.Key ResponsibilitiesOversee and control operational tasks performed by external partners involved...
Associate Director, External Manufacturing Biologics, Tech Transfer
vor 4 Monaten
Advocate for compliance to cGMP and BMS requirements, and provide Quality input and guidance to stakeholders.Carry out quality and compliance oversight and expertise to New Product Introduction (NPI), Technical Transfer (TT) projects to, from and within Contract Manufacturing Organizations (CMOs).Identify, assess, evaluate and escalate all significant quality risks and support adequate mitigation.Lead inspection readiness and ensure successful transition to commercial manufacturing
to deliver significant amounts and/or key products in the BMS External Manufacturing portfolio.Demonstrate proficiency in interpretation of FDA, EMA, Swiss and Rest of World cGMP and EU Good Distribution Practices (GDP) regulations for biologics drug substance, drug product and drug/device combination product manufacture, testing and distribution. ResponsibilitiesResponsible for the Quality onboarding of the CMO as per EXM Bio Quality requirements, and GCH requirements where applicable, including but not limited to Quality Agreement, SAP master data, product specifications, CMO Risk assessment, audit coordination with Global audit team.Ensure all quality deliverables related to the BMS-CMO set-up and the NPI / TT project deliverables generated for assigned Biological and Sterile product stages - i.e. Biologic Drug Substance (BDS) and Drug Product (DP) - meet the quality standard and cGMP regulations set by applicable health authorities and BMS procedures.Partner with project stakeholders to jointly define goals, action plans and deliverables aimed at ensuring successful and compliant NPI and TT of assigned products. Serve as Quality Lead for assigned programs.Establish a Quality partnership with the CMO and a joint quality governance.
Lead joint Quality to Quality meetings with the CMO and provide regular communication and progress reports to BMS management. Carry out on-site visits at the CMO as required.Perform reporting and escalation of quality issues and quality metricEnsure Quality by Design (QbD) principles are implemented for all new products at CMO’s. Participate in facility/ process gap assessments and risk assessments on BDS / DP
manufacturing processes as part of technical transfers to CMO from BMS.Perform Quality review and approval of protocols and reports for assigned NPI and TT projects, as well as associated GMP deliverables.
Review and approve exceptions and changes from project protocols.Lead pre-approval inspections readiness at CMOs.Manage all assigned Quality activities associated with vendor selection/ initial approval.Provide broad cGMP and GDP expertise to coach an interdisciplinary VPT team to ensure product compliance in the commercial manufacturing of Drug Substance, Drug Product and Drug/Device combination products, as applicable.Ensure BIO EXM Quality input to cross-functional international project teams to provide quality and compliance subject matter expertise and guidance to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T teams in support of changes in business needs as part of e.g. supplier selection process, technical transfers programs, investigations, validation programs.Work closely with BMS Quality Analytical group for analytical method transfers associated with overall product/process technical transfers.Partner with the BMS EXM Quality Services/Systems groups to maintain the quality system. Initiate and drive quality improvements through active discussions and follow-up.Represent BMS EXM Quality in Health Authority inspections fof the CMOs as a subject matter expert and ensure timely responses to any issues which may be identified.Decide about potential quality impact in quality events, change controls and market complaints in cooperation with BMS internal teams, as well as with CMOs.Manage the quality metrics programs in relation to CMO performance. Actively ensure CMOs adhere to key performance indicators agreed in the respective Quality Agreements through regular meetings.Recognize and escalate issues to CMO Senior Management to ensure that issues are resolved to prior to negatively impacting BMS business and compliance requirements.Actively support the BMS Investigational Review Board, Fact Finding and Product Review Committee processes for major investigations involving CMO products. Responsible to prepare and present relevant information to senior management.Perform preparation, review and revision of applicable Quality Agreements to support manufacture and testing of BMS products at CMOs.Prepare and/or review key GMP documentation, such as Annual Product Reviews, as required, for end to end product monitoring.Critically review manufacturing and testing batch packages in alignment with BMS operations functions to ensure compliance with testing standards, SOPs, validation guidelines, regulatory filings and cGMP and GDP requirements in preparation of batch release with a view to ensure the timely supply of drug substance and drug product to the BMS network, as applicable.Review, provide input and approve CMO batch related records, validation reports, deviations and change controls. Directly interface with CMO QA and project management regarding any potential compliance gaps, deviation resolution and regulatory inspections.Work with CMOs, vendors and external analytical laboratories to evaluate their audit and inspection readiness and work with these groups to ensure that appropriate corrective actions are made in advance of audits/inspections to support BMS expectations and successful outcomes.Lead or contribute to Operational Excellence projects in support of efficiency gains, while ensuring maintenance of BMS’s as well as CMO’s GMP/GDP compliance.Required Qualifications and Required CompetenciesMinimum BS (M.Sc.preferred) degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Chemistry, Biological Sciences or Related Pharmaceutical Science.Minimum of 12 years experience in (bio-)pharmaceutical operations. At least 5 years’ Quality Assurance experience in commercial (and ideally also development/clinical) pharmaceutical products with expertise in device/drug combination products and packaging operations is desired.Good verbal, written, and presentation skills in English.Experience with performing batch record review and lot disposition is desiredSolid knowledge of US and international GMP requirements in clinical and commercial environments.Experience with designing, leading or supporting technical transfers of biologic and/or sterile product.Experience in pharmaceutical product manufacturing, with demonstrated expertise with one or more of the following: biologic products, aseptic and/or sterile drug product manufacturingKnowledge of combination products manufacturing or finished drug product packaging a plus.Hands-on experience and/or education in Microbiology/Hygiene and aseptic operations is highly desirable.Ability to assess the right balance between quality decisions,
technical considerations and business implications.Strong negotiation, communication and presentation skills across all levels both, internal and external to BMS.Demonstrated technical expertise in resolution of deviations, development of effective CAPA and use of risk assessments.Experience in supply chain ERP systems or SAP and Infinity/Trackwise.Very good computer literacy, e.g. Microsoft Office Suite.Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met.If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
