Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

Reporting to the Senior Manager of Upstream Devens Manufacturing Technology, the Associate Engineer, 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.
* Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Large Scale Cell Culture facility.
* 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 2-4 years relevant experience, MS 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.
* Proven experience in successful execution of process technical transfer
* 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.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.