Associate Director of CMC - Quality Assurance

Regulatory Jobs; Indianapolis (IN); In loco; USD 165.000 - 200.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) retirement plan

Employee stock options

Descrizione del lavoro

RayzeBio is seeking an Associate Director of CMC - Quality Assurance at our Indianapolis, IN facility. You will drive QA strategy across drug substance, API, and analytics for radiopharmaceutical programs, partnering with Regulatory and cross-functional teams.

The ideal candidate has 10+ years in biologics/sterile development with cGMP experience and a track record of IND/BLA success. This role requires onsite work at the Indianapolis site and collaboration with San Diego/CMOs as needed.

Competenze

• Thorough knowledge of pharmaceutical development processes with IND/BLA experience.
• Expertise in radiopharmaceuticals or biologics development and manufacturing.
• Familiarity with cGMPs and regulatory requirements (FDA, EU, ICH).

Mansioni

• Lead QA input across CMC development from pre-clinical to post-approval.
• Oversee change control, deviations, investigations, CAPAs and QA reviews.
• Collaborate with Regulatory on filings and health authority communications.
• Provide risk assessments and quality guidance throughout development.

Conoscenze

CMC development

QA expert

cGMP knowledge

Regulatory filings

Biologics/radiopharma

Cross-functional leadership

Formazione

Bachelor of Science in Chemistry/Biochemistry

10+ years biologics/sterile experience

Regulatory familiarity

Descrizione del lavoro

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

The Associate Director of Chemistry, Manufacturing & 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). The emphasis of the position will be at the Indianapolis manufacturing facility and therefore, the incumbent must be located at the site. The incumbent will be responsible for multiple projects which may be at the Indianapolis site, San Diego, and/or CMOs.

Job Responsibilities

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

• 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. Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.

• Responsible for change control management for compound/product specific changes through the product lifecycle, including 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.

• 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.

• Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process. Communicate Quality risks within the Quality organization.

• 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.

• 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).

Education and Experience

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.

• Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).

• Prior experience in Quality is preferred.

An equivalent combination of education and experience may be substituted

Skills and Qualifications

• Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval. 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.

• Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.

• Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).

• Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.

• Excellent investigational and QA problem-solving skills. Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.

• Apply AI to improve team execution and decision‑making.

• Ability to work independently, yet effectively in a team environment.

• Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.

• 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).

• Other proven competencies such as strategic thinker, influencer and negotiator are required.

• Continuous improvement mindset is also required.

Physical Demands

While performing the duties of thisjob, 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 thisjobincludeclose vision and distance vision.

This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

WorkEnvironment

The noise level in theworkenvironment is usually moderate. Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).

Compensation Overview

Indianapolis - RayzeBio - IN: $164,838 - $199,745

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607186 : Associate Director of CMC - Quality Assurance