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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 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: careers.bms.com/working-with-us .

Position Summary

• Supporting the production of personalized cell therapy products for both clinical trials and commercial supply in region

• Providing day-to-day manufacturing support

• Leading manufacturing investigations pertaining to the process control strategy and associated elements

• Managing CPV and process monitoring program

• Support development and lifecycle management of MBR, SOP, and/or eBR

• Managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability

• Support creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) required to support the production of personalized cell therapy products

• Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization

Key Responsibilities

• Provide on the floor or remote process support for ongoing manufacturing activities when needed.

• Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.

• Lead deviation investigations utilizing root cause analysis tools.

• Lead product impact assessments to support investigations.

• Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).

• Interact with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory.

• Participate in routine plant operating meetings.

• Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.

• Support health authority and/or internal inspections.

• Write & review guideline procedures, protocols, and reports in Japanese and English.

• Work as a process SME to support clinical and commercial manufacturing, troubleshooting, deviation investigations and identify appropriate CAPAs.

• Oversee and perform manufacturing data trending to contribute to the lifecycle management of a process.

• Support process changes during the lifecycle.

• Train end-users and entry-level personnel on the manufacturing process.

• Interact with other CMC teams, Quality Operation, Clinical Operation, Regulatory, Facility and other personnel as dictated by project needs.

• Support tech transfer SME and help drive best practices and technical advancements.

• Flexibility to work multiple time zones as needed.

Qualifications & Experience

Specific Knowledge, Skills, Abilities:

• Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy and/or Aseptic processing experience is a major plus.

• Must have excellent organization skills and ability to handle multiple tasks.

• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.

• Possess strong verbal/written communication skills both in Japanese and English.

• Ability to think strategically and to translate strategy into actions.

Education/Experience/ Licenses/Certifications:

• Master's or Bachelor's Degree in in cell biology, biotechnology, biochemistry or equivalent with minimum of 6-7 years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.

• Experience with cell culture or aseptic techniques is preferred.

• Experience in a regulated, GMP manufacturing environment is required.

• Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.

• Previous experience with CMOs is preferred.

• Experience with regulatory agency inspections and regulatory responses is a plus.

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.

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 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.

On-site Protocol

BMS has a diverse 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.

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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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

Company: Bristol-Myers Squibb

Req Number: R1583948

Updated: 2024-09-14 04:40:33.560 UTC

Location: Otemachi-JP

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.