Senior Engineer - GMSampT Lab Lead

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.

Come and join Bristol Myers Squibb for this key role helping to build a leading CAR T Platform that serves our patients with novel CAR T Therapies. At BMS, we are developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

The engineer in this role will lead the start-up and on-going operation of a Global Manufacturing Science and Technology lab at the BMS Warren location. The lab will be responsible for executing business-critical activities for commercialization and post-commercial support of cell therapy processes. At a high-level, responsibilities for this role include:

1) Define capabilities of the new Global MS&T Lab in Warren - roles and responsibilities, lab space, equipment, workflows and best practices for lab operations that meet both internal standards and regulatory requirements including documentation, analytics, data handling and equipment/lab maintenance

2) Build a high functioning lab team (2-4 Engineers) focused on manufacturing support

3) Partner with GMS&T colleagues, leadership and stakeholders to prioritize activities, align on initiatives and drive critical projects to completion

4) Contribute to project teams to develop study protocols including study design, acceptance criteria, providing input on lab capabilities for study execution and timing

The engineer will be responsible for developing and leading a lab team executing projects to support commercial manufacturing which may include; raw material second sourcing, technical assessment of vendor changes, process improvements to reduce costs and improve efficiency, global validation and comparability studies and process investigations that require experiments and analytics beyond manufacturing site capabilities.

Job Description:

Major job duties include:

Build a team capable of executing end to end process experiments to support commercial manufacturing

Leadership/mentorship on experimental execution and data analysis for studies to support CAR T life cycle management projects within area of responsibility This will include hands-on experimental execution, especially as the lab team is being developed

Work with Manufacturing, Site MS&T, Process Development, Quality Assurance, Regulatory, and Analytical Development to define requirements and workflows for study execution, analytics, data storage and reporting

Implement and maintain standards and workflows for technical/operational best practices for study planning, execution and report writing

Support authoring of regulatory filings related to projects that come through the lab

Basic Qualifications:

PhD in Biological Science, Biomedical Engineering, Chemical Engineering, or related discipline with 4 years development / manufacturing technologies experience. OR

MS with 6 years development / manufacturing technologies for biologics experience OR

BS with 8 years development / manufacturing technologies for biologics experience

Experience performing mammalian cell culture and aseptic technique

Solid understanding of GMP/GLP requirements

Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations

A strong mindset for high-quality, meticulous and consistent execution of manufacturing processes and/or analytics

Excellent written and verbal communication skills at all levels in the organization

Strong interpersonal skills to work across multiple stakeholders and customers

Preferred Qualifications:

2-3 years of experience in cell therapy process development and/or manufacturing

2 years of direct management experience

Experience with commercial product support, i.e. post-marketing commitments, life-cycle changes, comparability

Combination of experience in Process Development and MSAT

Operational excellence training/background

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.

Company info

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