Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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.
Position Summary
This technical leadership role is a highly experienced subject matter expert in molecular biology analytical methods and related areas, responsible for leading the design, execution, and interpretation of complex, high impact scientific programs. This role will manage a team responsible for method optimization, transfer, and validation in support of Cell Therapy analytical portfolio. Conceptualize and lead complex projects, provides strategic scientific and technical input to the programs and projects. Apply technical knowledge, regulatory requirements, and scientific principles to independently perform complex troubleshooting and problem solving. The Senior Principal Scientist balances deep hands-on laboratory engagement with cross-functional leadership, mentoring, and delivering enterprise-level impact.
Duties/Responsibilities
Lead and manage a team responsible for molecular biology method technical investigation, method optimization/remediations, method transfer and method validation in compliance with regulatory requirements.
Perform and/or direct team on hands-on laboratory work in support of commercial QC analytical methods investigation, remediation, and/or optimization. Connects lab-level science to portfolio strategy, pipeline value, and organizational mission
Critically evaluate experimental data across the team, identifying scientific risks and opportunities, and recommending course corrections as appropriate. Integrate scientific findings across multiple experiments and datasets to generate meaningful insights and advance program hypotheses.
Act as a Subject Matter Expert (SME) in functional areas as needed.
Makes high-impact scientific and strategic decisions under conditions of uncertainty; balances scientific ambition with pragmatic risk management.
Represent the department in product review boards, regulatory inspections (internal and external audits). Own and author relevant analytical sections of regulatory submission and responses to health authority questions and requests.
Implement method lifecycle and method maintenance programs to support methods in support of viral vector and cell therapy drug products.
Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
Represent ASAT interest on cross functional/ cross-site teams and communicate and collaborate effectively.
Apply technical knowledge, regulatory requirements, and scientific principles to perform troubleshooting and problem solving for non-routine complex issues.
Hire, mentor, and develop exceptional ASAT personnel.
Reporting Relationship
This position will report to Analytical Science and Technology management
Qualifications
Specific Knowledge, Skills, Abilities:
Strong scientific background and expertise with various molecular methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
Demonstrated advanced technical writing skills.
Highly advanced strategic thinking and problem-solving ability/mentality, technically adept and logical.
Demonstrated ability to work independently in a fast-paced matrix environment, meet deadlines, and prioritize work from multiple projects. Track record of scientific productivity as evidenced by publications, presentations, or equivalent internal contributions
Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally.
Highly advanced technical skills, including execution, and interpretation of complex, high-impact scientific, multi-dimensional data in support of commercial QC analytical methods.
Expert at writing formal reports/documents and technical presentations in support of investigations and regulatory submission.
Advance biopharmaceutical industry experience with a clear and sustained track record of scientific leadership, innovation, and impact. Able to translate complex science for diverse audiences.
Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
Ability to travel to support projects as needed
Education/Experience/ Licenses/Certifications:
Bachelor’s/Master’s degree preferably in (bioanalytical) science. Advanced degree preferred.
10+ years of relevant experience in regulated cellular therapy or gene therapy, or an equivalent combination of education and experience.
Expert scientific knowledge with a broad range of molecular techniques including lentiviral, AAV vectors and other gene delivery platforms. Experience in bioanalytical techniques (cell-based assays, ELISA, flow cytometry) is a plus. Deep expertise with the characterization, validation, and transfer of bioanalytical methods lifecycle. Experience providing training in method execution as well as instrument operation and standardization.
Experience in cGMP regulations and application within the Quality Control environment. Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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