Sr. Engineer II Site Manufacturing Sciences and Technology

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

The Manufacturing Sciences and Technology Sr. Engineer II Clinical CAR-T Engineering and Technology Support is responsible for leading the tech transfer of novel cell therapy products for global clinical trials. Collaborates with SMEs from the Development Group, Global MSAT Group, Supply Chain Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

DUTIES AND RESPONSIBILITIES

Lead technology transfer initiatives:

Perform process transfer from Research/Development to Clinical Manufacturing.

Write & review procedures, protocols, and reports.

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

Perform manufacturing data trending to contribute to the lifecycle management of a process.

Author & review IND documents and provide necessary technical input to support regulatory discussions.

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. Contribute in a team-oriented environment to achieve common project goals.

Maintain knowledge of scientific literature & regulatory guidelines and apply key concepts to project activities/plans.

Support Clinical Production Activities;

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

Continuously monitor, anticipate and permanently resolve issues that may arise during production.

Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs

Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)

Display Leadership Qualities;

Create an environment of teamwork, open communication, and a sense of urgency

Support the change agent in promoting flexibility, creativity, and accountability

Support organizational strategic goals and objectives that are linked to the overall company strategy

Drive strong collaboration within the plant and across the network

Build trust and effective relationships with peers and stakeholders

Deliver results through timely and quality decision making and advice

Promote a mindset of continuous improvement, problem solving, and prevention

Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities

Expert knowledge of cGMP's and multi-national biopharmaceutical/cell therapy regulations

Deep knowledge of facility/clean room design, process, equipment, automation, and validation

Deep knowledge of technology transfer and QbD processes

Intermediate strong verbal/written communication skills and ability to influence at all levels

Intermediate ability to think strategically and to translate strategy into actions

Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment

Intermediate knowledge of quality by design and risk management

Intermediate experience with Operational Excellence and Lean Manufacturing

EDUCATION AND EXPERIENCE

Experience with tech transfer of a cell therapy product preferred

Bachelor's Degree in engineering (advanced degree is preferred)

10 or more years of manufacturing support or process development experience in the biopharmaceutical industry

WORKING CONDITIONS: (US Only)

PHYSICAL /MENTAL DEMANDS:

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

ENVIRONMENTAL CONDITIONS:

Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526421_EN

Updated: 2020-06-15 00:00:00.000 UTC

Location: Warren,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