Sr Scientist CMC and Technology Transfer Radiopharmaceuticals
Sr Scientist CMC and Technology Transfer Radiopharmaceuticals
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
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 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: 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.
Position Summary
The Sr. Scientist Radiopharmaceuticals will be responsible for advancing scientific and technical projects across various scientific production operations quality and regulatory teams to support development and commercialization of radiopharmaceuticals. Responsibilities include driving technology transfer Chemistry Manufacturing and Control (CMC) development and commercialization programs for drug products and radioisotopes.
Key Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Drive development and lifecycle management of radiopharmaceuticals and radioisotopes.
Drive technology transfer of drug products and API within RayzeBio and at external manufacturing partner locations (CDMO) to achieve clinical and/or commercial scale manufacturing.
Design plan and execute scientific experiments for scale up and automation of drug products and API manufacturing processes.
Author technical reports and source documents to support regulatory filing.
Author CMC sections for IND/NDA for FDA submissions and support regulatory filing in other jurisdictions e.g. EMA Health Canada etc.
Collaborate crossfunctionally with Regulatory Quality Supply Chain Clinical and R&D teams to ensure alignment with corporate goals
Provide Support commercialization of drug product and API
Up to 20 of travel required
Education and Experience
Ph.D. M.S. or B.S. in Chemistry Chemical Engineering Pharmaceutical Sciences or a related field with requisite industry experience.
5 years of experience in drug development manufacturing CMC or related fields in a pharmaceutical industry preferably radiopharmaceuticals.
Skills and Qualifications
Strong understanding of GMP FDA/EMA regulations and ICH guidelines.
Strong problemsolving abilities and the ability to manage multiple projects in a fastpaced environment.
Excellent project management and crossfunctional collaboration skills.
Excellent technical writing skills.
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 15 pounds. Specific vision abilities required by thisjobincludeclose 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.
WorkEnvironment
The noise level in theworkenvironment is usually moderate.
#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 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.
Onsite Protocol
BMS has a diverse 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:
Senior IC
Employment Type
Remote
Company Industry
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
