Principal Engineer/Sr. Manager Biologics Manufacturing

Profile

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.

Principal Engineer/Sr. Manager, Biologics Manufacturing

Position Summary

This position is part of BMS internal Biologics Manufacturing Team responsible for ensuring the robust execution of our Biologics in cGMP Manufacturing. The main responsibility is management of technology transfer projects which supports BMS expanding early and late stage clinical pipeline. The individual will work closely with Biologics Development, Supply Chain, and Quality to ensure all aspects of technology transfer are successfully executed. In addition, the individual will be responsible for establishing systems to managing process information and for data analytics used for investigations and process optimization. The incumbent will establish interrelationships between process development, manufacturing, quality and regulatory aspects of product development and be able to apply understanding to propose improvements cross-functionally.

This position will also support the successful design, qualification, and startup of clinical cGMP manufacturing operations at BMS. The individual will serve as a process equipment expert in equipment selection, will manage equipment qualification activities, and will be hands on solving issues during start up. BMS evolving Biologics teams will allow for high throughput, highly productive cGMP manufacturing operations fueling a fast paced environment. This position offers an experienced individual a significant opportunity to establish best practices for technical support of cGMP manufacturing operations.

Responsibilities

Demonstrates ability to train and mentor new employees, participates in inter-departmental teams, demonstrates ability to lead technical sub-teams; may supervise the operation work of others

Lead cross functional technology transfer teams for internal and cGMP manufacturing.

Track and coordinate project milestones related to raw materials, equipment readiness, analytical testing, process information, and manufacturing documents to initiate and complete batches per the production schedule.

Ensure cGMP batch documentation allow the process to achieve the intended process control strategy. Ensure that the process is capable of achieving control limits and specifications

Informs personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.

Investigate, identify root cause, and identify CAPA for manufacturing deviations.

Trend process performance. Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Development for scale up / process transfer.

Author technical reports and protocols in support of cGMP activities.

Coordinate sampling plans for GMP batches related to lot release, stability, and characterization.

Partner with Process Development to ensure successful process transfer.

Collaborate with Process Development on opportunities to improve process performance and cGMP operations.

Provide technical leadership and manufacturing operations support; driving process, product, and operational improvements across the DS internal network and external manufacturing sites.

Assist in equipment selection, qualification, and start up activities. Work with internal Manufacturing to ensure robust procedures are utilized for operation of equipment.

Qualifications

Biochemical engineer, Chemical engineer, or Biochemistry background. Ph.D. with 4 years' experience or MS/BS with 11 years' experience in a pharmaceutical or biotechnology company.

Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.

Experience in biologics process development or cGMP manufacturing of biologic products.

Demonstrated expertise in scale-up and process transfer for either cell culture/fermentation unit operations or protein/nucleic acid purification unit operations.

Experience implementing biotechnology unit operations including fermentation, enzymatic reactions, chromatography, tangential flow filtration, and terminal filtration.

Experience in single use bioprocessing technologies.

Proven track record leading and managing cross functional teams.

Knowledge of data management tools and statistical process control

Experience writing and revising standard operating procedures and batch production records

Experience with operating and troubleshooting process equipment

Experience working on late phase and commercial programs is a plus

Demonstrate ability to play the role of future group leader. Demonstrate ability to impact and influence the decisions of a team, external parties, and higher level group.

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.

Company: Bristol-Myers Squibb

Req Number: R1526884_EN

Updated: 2020-06-24 00:00:00.000 UTC

Location: Summit,New Jersey

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com