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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 the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.SummaryThe Associate Director of Chemistry, Manufacturing &amp; Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals).&nbsp; The emphasis of the position will be at the Indianapolis manufacturing facility and therefore, the incumbent must be located at the site.&nbsp; The incumbent will be responsible for multiple projects which may be at the Indianapolis site, San Diego, and/or CMOs.Job ResponsibilitiesEssential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle including NDA filing, other market filings, and post approval changes.&nbsp; Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.</li><li>Responsible for change control management, for compound/product specific changes, through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate and compound/product specific, responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints.</li><li>Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.&nbsp;</li><li>Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization.</li><li>Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g. IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.</li><li>Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).</li></ul>Education and Experience<ul><li>Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.&nbsp;&nbsp;&nbsp;</li><li>Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).</li><li>Prior experience in Quality is preferred.</li><li>An equivalent combination of education and experience may be substituted</li></ul>Skills and Qualifications<ul><li>Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval.&nbsp; Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.&nbsp;</li><li>Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.</li><li>Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).</li><li>Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.</li><li>Excellent investigational and QA problem-solving skills.&nbsp; Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.&nbsp;</li><li>Ability to work independently, yet effectively in a team environment.</li><li>Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.</li><li>Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).</li><li>Other proven competencies such as strategic thinker, influencer and negotiator are required.&nbsp;</li><li>Continuous improvement mindset is also required.&nbsp;</li></ul>Physical DemandsWhile performing the duties of this&nbsp;job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this&nbsp;job&nbsp;include&nbsp;close vision and distance vision.&nbsp;This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.&nbsp; Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).#RayzeBioIf 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 Careers With 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 a supportive culture, promoting global participation 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 ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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 <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb

Associate Director of CMC, Quality Assurance

Title:&nbsp;Director of Pathways to USI Division: Student Affairs Department: Student Affairs FLSA Status:&nbsp;Exempt Salary Range:&nbsp;Annual Salary EEO Job Group:&nbsp;1.1 C1 Position Summary The University of Southern Indiana is accepting applications for&nbsp;Director of Pathways to USI. Under the supervision of the Vice President of Student Affairs, the Director is responsible for the overall planning, coordination, and daily operations of the Pathways to USI Program. This includes determination of program needs, formulation of corresponding action plans, and engagement with faculty and staff to provide student success and support program activities and services. Duties/Responsibilities&nbsp; Direct Service with Students <ul><li>Manage strategic planning for Pathways to USI</li><li>Create and manage student cohort model</li><li>Manage summer program recruitment, application, and enrollment process</li><li>Design and implement Pathways orientation programs, including parent orientation</li><li>Develop communications to all admitted Pathway Scholars prior to, and during their time in the Pathways Program</li><li>Manage all events, campus connections, and programming during the summer term for all Pathway Scholars</li><li>Work closely with university housing staff to coordinate all aspects that impact the residential component of the Pathways Program</li><li>Provide and coordinate academic assistance to each Pathway scholar by monitoring academic progress, attendance, and persistence</li><li>Design and implement an effective series of academic and cultural events and workshops throughout the year</li><li>Develop and expand learning strategy and academic support services to further meet student needs, narrow resource gaps, and integrate campus support</li><li>Manage and maintain the program budget and expenditures</li><li>Collect data for all parts of Bridge Programs and disaggregate data and create reports other records to assess accomplishments</li></ul> Direct Service with Student Affairs Division and University <ul><li>Assist in the planning and implementation of initiatives to advance institutional inclusivity student engagement through design, delivery, and assessment</li><li>Leading student development and community engagement efforts to broadly engage all students, faculty, staff, and community members to fulfill the University’s goals around student success</li><li>Review organizational practices, processes, and structures across USI’s programs and functions to identify needed improvements towards achieving student success</li><li>Partner with Marketing and Communications</li><li>Identify, build, and sustain campus partnerships with student organizations, colleges, and campus stakeholders to support student success</li></ul> Required Knowledge and Skills <ul><li>Master's degree in Student Affairs or related field.</li><li>Professional experience must include two or more years assisting college students.</li><li>Demonstrated ability to connect well and understand the needs and concerns of students by providing emotional support, academic assistance and life-skill development.</li><li>Demonstrated experience planning, implementing, and assessing a wide variety of small- and large-scale programs.</li><li>Demonstrated ability to establish and maintain effective collaborative relationships with organizations.</li><li>Financial management experience.</li><li>Ability to build and manage teams in a college setting.</li><li>Must possess working knowledge of, and the ability to apply, research and theory from professional and scholarly literature.</li><li>Significant and articulate knowledge of developmental and human issues that impact the emotional, academic and career success of students.</li><li>Experience in creating programs and services designed to improve the emotional, interpersonal, academic and career success of diverse</li></ul> Preferred Knowledge and Skills Experience in a university or college setting in a helping and advocacy capacity. About USI&nbsp; &nbsp; The University of Southern Indiana is a public higher education institution located on a beautiful&nbsp;1,400-acre campus in Evansville, IN. We offer employees exceptional benefits! Benefits for this&nbsp;position include: <ul><li>Affordable medical, dental, vision, life and short term and long-term disability insurance plans.</li><li>Retirement plan where the University makes the total contribution equivalent to 11% of annual salary.</li><li>Full tuition fee waiver for employees/75% for spouses and dependent children.</li><li>Vacation and sick time</li><li>Holiday pay</li><li>Free access to Recreation, Fitness &amp; Wellness Center.</li><li>Access to on-campus University Health Center and Dental Hygiene Clinic.</li></ul> For more information about the benefits that USI offers, please visit <a href="http://www.usi.edu/hr/benefits" target="_blank">www.usi.edu/hr/benefits</a>. Application Process Click “Apply Now!” near the top right of this page to complete an application and upload application materials to the attention of the Search Committee Chair. Application materials should include: <ul><li>Resume</li><li>Cover Letter</li><li>Unofficial Transcripts</li></ul> Search Committee Chair: If you have questions about the open position, please contact Ms. Jada Hogg, search committee chair, at <a href="mailto:jhogg@usi.edu" target="_blank">jhogg@usi.edu</a>. Best Consideration Date: For best consideration, please submit materials before April 23, 2025. Pre-Employment Screening A background check will be required for employment in this position. Authorization to Work in the United States USI typically not sponsor an employment-related visa for this position. Interview Accommodations Persons with disabilities requiring accommodations in the application and interview process please contact the manager of Employment at <a href="mailto:mcweinzapf@usi.edu" target="_blank">mcweinzapf@usi.edu</a> or (812) 464-1840. Contacting the manager of Employment is intended for use in seeking disability-related accommodations only. For general applicant inquiries, contact Human Resources at <a href="mailto:HumanRes@usi.edu" target="_blank">HumanRes@usi.edu</a> or (812) 464-1815. EEO Statement The University of Southern Indiana is an&nbsp;EEO/AA employer. All individuals including minorities, women, individuals with disabilities and veterans are encouraged to apply.

University of Southern Indiana

Director of Pathways to USI

Title:&nbsp;Director of Honors Program &amp; Themed Learning Communities Division: Provost's Office Department: Honors Program FLSA Status:&nbsp;Exempt Salary:&nbsp;$73,000 EEO Job Group:&nbsp;1.2 C2 Position Summary Reporting to the Assistant Provost for Academic Affairs, the Director of Honors Program &amp; Themed Learning Communities has primary responsibility for the continuous development, implementation and assessment of co-curricular learning, student recruitment and retention, and academic advising in the Honors program. Duties/Responsibilities&nbsp; Honors Program: <ul><li>Oversee all aspects of the Honors program including coordinating curriculum development for the program in consultation with the Honors Faculty Council, Deans, College and University Curriculum Committees, and the Faculty Senate; actively contributing to outreach, recruitment, and retention of honor students; participate in the university’s orientation sessions and open houses, and provide guidance and support for the development of honors sections of classes and the recruitment of instructors.</li><li>Establish and maintain a close working relationship with Honors students.</li><li>Meet and advise prospective Honors students to discuss the Honors Program, its requirements, curriculum and the admissions process and provide guidance and assistance to the Honors Student Council. Assess the quality and success of the Honors Program.</li><li>Serve as Chair the Faculty Honors Council.</li><li>Plan co- and extra-curricular activities and events that will enhance the Honors program.</li><li>Manage the budget for the Honors program.</li><li>Teach courses in the Honors Program, TLC Program, and others.</li></ul> Themed Learning Communities: <ul><li>Oversee all academic aspects of the Themed Learning Communities (TLC), including recruiting and retaining TLC students, providing training for TLC sponsors, working with departments for TLC course selections, and assessing and evaluating the TLC programs annually.</li><li>Collaborate with faculty to extend academic excellence and enthusiasm for learning throughout curriculum and into the themed learning community.</li><li>Chair the Themed Learning Community Committee.</li><li>Manage the budget for the TLC program.</li></ul> Service: <ul><li>Market Nationally Competitive Scholarship opportunities to students and assist students with the application process.</li><li>Serve on the Merit Scholar Selection Committee. Monitor the progress of Merit Scholar recipients and serve as the point of contact for the scholarship recipients.</li></ul> Required Knowledge and Skills <ul><li>Master’s degree in an academic discipline.</li><li>Excellent interpersonal, leadership, and communication skills.</li><li>Demonstrated aptitude for building community partnerships, communicating with students and parents, engaging students in challenging curricular and co-curricular educational experiences, and forging strong connections with Academic Affairs, Student Affairs, Housing and Residence Life and other administrative departments across campus.</li><li>Experience and knowledge of key issues in Honors education and Living Learning Communities, with commitment to principles of liberal education and interdisciplinary studies.</li><li>Successful administrative experience in higher education, including program development and assessment, faculty relations, and student engagement, recruitment, and retention.</li></ul> Preferred Knowledge and Skills Doctorate or appropriate terminal degree in an academic discipline. Faculty rank may be awarded if the candidate has an established record of teaching, scholarship, and service that qualifies for an academic position in one of the disciplines within the university. About USI&nbsp;&nbsp; The University of Southern Indiana is a public higher education institution located on a beautiful&nbsp;1,400-acre campus in Evansville, IN. We offer employees exceptional benefits! Benefits for this&nbsp;position include: <ul><li>Affordable medical, dental, vision, life and short term and long-term disability insurance plans.</li><li>Retirement plan where the University makes the total contribution equivalent to 11% of annual salary.</li><li>Full tuition fee waiver for employees/75% for spouses and dependent children.</li><li>Vacation and sick time</li><li>Holiday pay</li><li>Free access to Recreation, Fitness &amp; Wellness Center.</li><li>Access to on-campus University Health Center and Dental Hygiene Clinic.</li></ul> For more information about the benefits that USI offers, please visit <a href="http://www.usi.edu/hr/benefits" target="_blank">www.usi.edu/hr/benefits</a>. Application Process Click “Apply Now!” near the top right of this page to complete an application and upload application materials to the attention of the Search Committee Chair. Application materials should include: <ul><li>Letter of Application</li><li>Current curriculum vitae</li><li>Unofficial transcipts</li></ul> Official transcripts will be required at a later stage. Search Committee Chair: If you have questions about the open position, please contact Dr. Jason Hardgrave, search committee chair, at <a href="mailto:jhardgrave@usi.edu" target="_blank">jhardgrave@usi.edu</a>. Best Consideration Date: For best consideration, please submit materials before March 24, 2025. Pre-Employment Screening A background check will be required for employment in this position. Authorization to Work in the United States USI will not sponsor an employment-related visa for this position. Interview Accommodations Persons with disabilities requiring accommodations in the application and interview process please contact the manager of Employment at <a href="mailto:mcweinzapf@usi.edu" target="_blank">mcweinzapf@usi.edu</a> or (812) 464-1840. Contacting the manager of Employment is intended for use in seeking disability-related accommodations only. For general applicant inquiries, contact Human Resources at <a href="mailto:HumanRes@usi.edu" target="_blank">HumanRes@usi.edu</a> or (812) 464-1815. EEO Statement The University of Southern Indiana is an&nbsp;EEO/AA employer. All individuals including minorities, women, individuals with disabilities and veterans are encouraged to apply.

Director of Honors Program & Themed Learning Communities

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 the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.The Director, Production is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Director, Operations and be primarily responsible for directing the day-to-day production activities to achieve corporate objectives at the site.&nbsp; The Director, Production will oversee and lead a team of production personnel to successfully deliver quality finished radiopharmaceutical products, on time, and in accordance with the production schedule.&nbsp; Additional responsibilities will include working with the Director, Operations in readying the site for scalability, as we work towards commercialization goals and expanded pipeline products.Job Responsibilities<ul><li>Provide leadership and direction to members of the production team including manager(s), supervisor(s), operator(s), and associate(s).</li><li>Collaborate with other functional areas for the triage of deviations, investigations, and CAPAs.</li><li>Represent production for the internal and external technical transfer of future projects.</li><li>Collaborate with the Project Management team to assure production schedule adherence.</li><li>Assist the Director, Operations in mentoring and development of key members of the production team.</li><li>Align with leadership on the Isotope Production team to ensure GMP compliance and synergy across all operations at the site.</li><li>Work with Quality, Validation, Engineer Services and Facility Engineering counterparts to successfully develop and implement novel radiopharmaceutical technologies.</li><li>Work with EM/Microbiology team to ensure contamination control strategies are followed and any OOT or OOS issues are addressed in a timely manner.</li><li>Develop and manage production related performance metrics.</li><li>Assist the Director, Operations with production-related budgeting. &nbsp;</li><li>Ensure production personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.</li><li>Review, author and/or revise technical documents (SOPs, forms, deviations, etc.) as needed.</li><li>Up to 15% of travel required.&nbsp;</li></ul>Education and Experience:<ul><li>10+ years’ manufacturing experience in a cGMP injectable or Radiopharmaceutical environment is required.</li><li>Proven production leadership and management experience.</li><li>Demonstrated experience creating and managing production related metrics.</li><li>Working knowledge of industry related electronic systems (ERP, EQMS, etc.)</li><li>BS or MS Degree in a related technical field.</li></ul>Skills and Qualifications:<ul><li>Proven leadership and personnel management experience.</li><li>Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.</li><li>Excellent professional ethics, integrity, and ability to maintain confidential information.</li><li>Organized and detail oriented.</li><li>Strong time management and organizational skills.</li><li>Strong interpersonal communication skills.</li><li>Motivated, adaptable, and able to work under pressure.</li></ul>Physical Demands:While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear and climb stairs with or without accommodation. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and distance vision.This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.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 Careers With 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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 <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Director, Production

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 the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.RayzeBio is seeking a Director of Quality Operations at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA). &nbsp;This role will be responsible for overseeing all Quality aspects related to GMP production of Isotopes and the RayzeBio pipeline of radiopharmaceutical drug products for global clinical trial and commercial use. This role will partner with external and internal stakeholders driving Quality Systems at the Indianapolis site. &nbsp;The Director of Quality Operations will drive a culture of Quality and ensure GMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.&nbsp; Additional responsibilities include establishing and managing Quality Operational KPI’s, supporting and driving operational improvements within the Quality organization. &nbsp;The Director of Quality Operations will support the sites transition for clinical to commercial operations and be a key Quality leader supporting operational readiness for QP, PAI and other Regulatory Authority quality audits. This role will drive a site culture of Quality with a patient first mindset. Key Responsibilities:Essential duties and responsibilities include the following. &nbsp;Other duties may be assigned.<ul><li>Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.</li><li>&nbsp;Ensure adherence to applicable GMP regulations and company policies and procedures.</li><li>Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.</li><li>&nbsp;Provide leadership and build an exceptional Quality Operations team.</li><li>Champion and foster a positive and quality compliant culture with a patient safety mindset.</li><li>Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.&nbsp;</li><li>Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).&nbsp;</li><li>Establish and manage Quality Operational KPI’s and related metrics.</li><li>Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&amp;T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.</li><li>Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.</li></ul>Education and Experience:<ul><li>BS/MS in relevant Science or Engineering discipline and 10+ years of experience in building, managing and leading Quality Operations teams</li><li>Proven expertise in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations required.</li><li>Strong background in US/EU regulations with regulatory agency inspection experience required.</li><li>Experience implementing and improving GMP Quality systems related to commercial manufacturing operations is required</li><li>Demonstrated Quality leadership through a partnership approach with manufacturing and other Quality teams to enable high quality and compliant product distribution to patients is required</li><li>Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships&nbsp;</li><li>Demonstrated excellence in written and verbal communication&nbsp;</li><li>Previous experience in a commercial GMP parenteral facility, previous Radiopharma experience a plus</li></ul>Skills and Qualifications:Beyond having the requisite experience and qualifications, a successful candidate will have a proven history of team and personnel leadership with high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving. This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.&nbsp;#LI-ONSITE #RayzebioIf 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 Careers With 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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 <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

5 Leadership / Executive Board Jobs in Indiana