Senior Engineer - Devens, United States - Bristol-Myers Squibb

Description

**Working with Us**

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: .

**Position:** Senior Engineer/ Principal Engineer

**Location** : Summit, NJ / Devens, MA

At Bristol Myers Squibb we are reimagining the future of **cell therapy** . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

**Position Summary**

Come, join the BMS Cell Therapy Technical Operations (CTTO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group within CTTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for a **Senior Engineer/Principal Engineer** to join our Viral Vector Commercial Network MS&T group.

The primary responsibility will be commercial manufacturing support of our CMO's GMP manufacturing facilities. Additional responsibilities include Implementation of operational improvements and resolving manufacturing process investigations. The engineer will be part of a team tasked with determining the root cause of manufacturing investigations.

Additionally, the engineer will write technical reports in support of manufacturing process changes, optimizations, and regulatory filings. Optimizing the manufacturing process and determining root cause of manufacturing deviations are critical to ensure uninterrupted vector supply for BMS' clinical and commercial cell therapy assets. In addition to commercial manufacturing support, the successful candidate will be part of a team responsible for transferring commercial manufacturing processes.

The candidate will play a key role in product lifecycle management, including strategic development, validation, and approval of viral vector products. This person will collaborate across functional teams to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

**Key Responsibilities**

+ Support all MSAT activities at CMOs to ensure uninterrupted clinical/commercial vector manufacturing and supply.

+ Provide technical process support for routine clinical/commercial batches and assist QA with on time closure of all quality system records such as deviations, CAPAs and change controls.

+ Develop, understand, and manage tools/templates to monitor vector manufacturing process performance and enable understanding of process capability.

+ Implement and support the execution of process control strategies including execution of process risk assessments, and CPV.

+ Ensure the manufacturing process is in a state of control, through an understanding of CPV data.

+ Support production related investigations, ensuring compliance with internal standards and regulatory requirements.

+ Leverage and maintain strong relationships with external CMOs and their vendors.

+ Support permanent inspection readiness and actively support regulatory inspections.

+ Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.

+ Share operational best practices and process learning with the rest of the manufacturing network.

**Knowledge & Skills**

+ Experience with cellular therapies is desired but not required.

+ Proficiency in performing statistical analysis (using JMP or other software) and ability to interpret the output and draw conclusions.

+ Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.

+ Flexibility to work within manufacturing schedules and ability to travel frequently (50%).

+ Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills.

+ Strong interpersonal skills required to work with teams in different functions and organizations.

+ Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.

+ Proficiency utilizing MS Office products and working knowledge of JMP or other statistical software to perform correlative analysis is required.

+ Detail oriented with excellent verbal and written communication skills.

**Qualifications & Experience**

+ Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with

+ B.S. with 8-10 years of relevant experience

+ M.S with 6 - 8 years of relevant experience

+ Ph.D. with 5-7 years of relevant experience

+ Experience level will determine position title and enterprise grade level.

**Why You Should Apply**

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

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.

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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 . Visit 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:** R

**Updated:** :58:45.363 UTC

**Location:** Summit West-NJ

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.