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Upstream Commercial Manufacturing Technology (MT/MST) Engineer

Employer
Bristol Myers Squibb Company
Location
Devens, Massachusetts
Start date
Feb 15, 2024

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Job Details

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 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

Reporting to the Senior Manager of Upstream Devens Manufacturing Technology, the Manager, Manufacturing Technology is to serve as a process technical expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens. This position offers the opportunity to provide highly visible technical leadership to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will set appropriate objectives and priorities, overcome obstacles; and deliver results within project timelines. Expertise and experience in the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are highly desired. Demonstrated skills in cross-functional partnerships, supporting cross-functional teams and knowledge of regulatory and cGMP requirements are required.

Key Responsibilities

  • Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, review and approval of change controls and preparation of regulatory filings.
  • Performs root cause investigations and develops CAPAs as needed for process deviations.
  • Develops process performance data trending for continuous process verification and process improvement.
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
  • Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures and incorporate into all assigned projects.
  • Authors technical documents, including protocols, reports and SOPs supporting the validation of the biopharmaceutical product manufacturing.

Qualifications & Experience

  • BS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent.
  • BS or equivalent with 4-5 years relevant experience, MS or equivalent with 2-4 years relevant experience, PhD or equivalent with 0-2 years relevant experience.
  • Knowledge of process engineering and science generally attained through studies resulting in a B.S. in engineering, a related discipline, or its equivalent.
  • Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment.
  • Experience in designing and executing process and equipment validation plans
  • Knowledge of biopharmaceutical facility design and manufacturing operations. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.
  • Successful experience in project management including proficient use of project management tools and software such as MS Project and other collaborative systems.
  • Experience in the design, modification and optimization of biologics production processes
  • Strong experience in investigating process deviations and developing issue resolving CAPAs
  • Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization
  • Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.

Principal assignment is in a modern biopharmaceutical facility which requires adherence to various Personal Protective Equipment (PPE) standards.

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, 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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 is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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