Associate Director of CMC Quality Assurance
Associate Director of CMC Quality Assurance
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: 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 against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.
Summary
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 preclinical 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 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.
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. Responsible for communicating 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 shelflife 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 handson 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).
Wellversed in relevant CMC area with an ability to introduce Qualityrelevant (phase appropriate) best practices into the CMC development processes.
Excellent investigational and QA problemsolving skills. Analytical mindset with an ability to assess new situations to define and implement the appropriate QA action plan.
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 fastpaced 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. Workrelated travel (outside of Indianapolis Indiana) may be required up to 20 of working time (e.g. 10 weeks per year).
#RayzeBio
If you come across a role that intrigues you but doesnt 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 Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Remote
