Sr. Engineer 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 Clinical CAR-T Engineering and Technology Support is responsible for supporting the production of personalized 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

Ensure safe and compliant cGMP operations;


Maintain permanent inspection readiness and actively support regulatory inspections.

Interface with regulatory authorities as required to support Manufacturing Operations audits.

Foster a culture of compliance and strong environmental, health, and safety performance.

Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities6.

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

Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)

Sponsor and support the change initiatives and the implementation of process improvement initiatives


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.

Lead use of new automated technologies into the clinical site, serve as SME for Delta V process changes and OSI Pi process data monitoring dashboards.

Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.

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)

Interact with other teams including Validation, Development, Operations, QA and Regulatory


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

Intermediate knowledge of Delta V and OSI Pi

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 the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities

Bachelor’s Degree in science or engineering (advanced degree is preferred)

7 or more years of manufacturing support or related experience in the biopharmaceutical industry

Minimum of 3 years of Delta V and OSI Pi experience in biopharmaceutical manufacturing preferred


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

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.

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, disability or protected veteran status.

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