Senior Scientist, Drug Product Analytical Science And Technology (ASAT), Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. 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 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: Summary:

Function as a molecular biology analytical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in development of molecular biology methods as well as transfer validation and life-cycle management of test methods in a cGMP environment.

Duties/Responsibilities:

• Provide molecular biology analytical expertise in support of QC lab investigations. This encompasses participating in technical investigations identifying root cause and providing corrective and preventive actions including method remediations.
• Support transfer of commercial molecular biology methods and method validation in compliance with global regulatory requirements.
• Responsible for the stewardship of molecular biology methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support molecular biology methods in support of viral vector and cell therapy drug products.
• Author revise and review technical documents such as test methods SOPs trend reports and/or investigation reports as appropriate.
• Lead project CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.
• Provide support in the authoring of the analytical sections of regulatory submissions responding to health authority questions and to function as the method validation and method transfer expert during inspections.
• Partner with development organizations in the design of development and qualification studies selection and characterization of reagents and method optimization initiatives. Represent the function on cross-functional project teams.
• Train and mentor others on molecular biology techniques methods and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Qualifications:

• Bachelors degree in relevant scientific discipline or equivalent is required. Advanced degree preferred.
• 8 years of relevant analytical experience or equivalent combination of education and experience preferably in a regulated environment (GMP) cellular therapy or gene therapy.
• Advanced experience with various molecular biology methodologies including those related to lentiviral AAV vectors and other gene delivery platforms.
• Experience in analytical method lifecycle including method transfer validation and maintenance. Experience providing training in method execution as well as instrument operation and standardization.
• Experience in cGMP regulations and application within the Quality Control environment.
• Strong 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.
• Must possess effective time management skills demonstrate initiative resourcefulness and flexibility to work independently and as part of a team.
• Strong technical writing experience (SOPs Method Validation Protocols and Reports)is required.
• Advance ability to communicate effectively with peers department management cross-functional peers.
• Ability to travel to other BMS sites or Partner sites is required.

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.

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 employees 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 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 . Visit 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: Protection

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