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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 a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer.  Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary           

RayzeBio is seeking a Director, Site Quality Lead, at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA).  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 Operations and the Systems at the Indianapolis site.  The site Quality Lead will drive a culture of Quality and ensure cGMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.

Additional responsibilities include establishing and managing Quality metrics, Quality KPIs, supporting and driving operational improvements within the Quality organization.  The site Quality Lead will support the sites transition for clinical to commercial operations and be a key Quality leader supporting readiness for internal audits, EU QP audit, PAI, and other Regulatory Authority quality inspections. This role will drive a site culture of Quality with a patient first mindset.

This role is stationed in Indianapolis, IN and reports to the Head of Quality s for RayzeBio.  It is a people manager position, and the employee will be required to work exclusively at the manufacturing site.  

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Responsible for Quality Operations and systems oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.

• Ensure adherence to applicable cGMP regulations and company policies and procedures.

• Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of cGMP policies and procedures.

• Provide leadership and build an exceptional Quality team at the site.

• Champion and foster a positive and quality compliant culture with a patient safety mindset.

• Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.

• Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).

• Establish and manage Quality Operational KPI’s and related metrics.

• Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.

• Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.

Education and Experience

·BS/MS in relevant Science or Engineering discipline and 10 years of experience in building, managing and leading Quality teams. 

·Prior experience in leading Quality teams at a manufacturing site is preferred.  Proven expertise in cGMP operations and compliance for human use parenteral dosage forms or direct radiopharmaceutical operations experience is preferred. 

·Strong background in US/EU regulations with regulatory agency inspection experience required.

·Experience implementing and improving cGMP Quality systems related to clinical (initially) and commercial (in next two years) manufacturing operations is required

·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

·Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

·Demonstrated excellence in written and verbal communication

·Previous experience in a commercial cGMP parenteral facility will be considered a plus

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.

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. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. Routine walks around the building where the employee will be in close distance from where other employees will be handling hazardous materials. 

Work Environment

The noise level in the work environment is usually moderate.  The work location (the site) is actively handling hazardous materials (e.g., flammable solvents, corrosive liquids, radioactive materials). 

#LI-ONSITE #Rayzebio

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 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 Protocol

BMS 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 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.

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: https://careers.bms.com/california-residents/

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