Principle Clinical Manufacturing Specialist

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

PURPOSE AND SCOPE OF POSITION:

BMS Cell Therapy Manufacturing seeks a leader with Biosystems Engineering background and experience in Quality Systems change management, spanning Change Control ownership and Document writing, minimally. This role will be tasked with assisting in Process Development, execution of; Engineering runs, Comparability runs, and other process development work. This role is designed to be a working leader on tech transfers, implementing a process drafted by the Process Development team, through successful implementation into production. It is expected that this role becomes an end-to-end process SME throughout all phases of production from clinical through commercial.

DUTIES AND RESPONSIBILITIES:

• Draft procedures and Master Batch Records for new processes under development.
• Design process flows that are suitable for commercial implementation.
• Understand and apply the criticality of Data Integrity and Quality Compliance in document drafting.
• Own change controls supporting deployment and continuous improvement of new processes.
• Execute operations on the floor to support process development and shake down.
• Leverage Lean operational principles while drafting procedures.
• Assist in equipment and process Qualifications wherever necessary.
• Become Manufacturing SME for all clinical processes implemented at site.
• Document reviewer for new and revised process updates.
• Train staff on process changes, transferring knowledge and the “why” behind changes.
• Network with Global team on Process Development changes and execute changes locally.
• Manage document lifecycle for related clinical manufacturing documentation, from editing through approval as appropriate.
• Complete periodic reviews of clinical documentation.
• Facilitate successful execution of Clinical Manufacturing in ways beyond this description as necessary.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

Education and Experience:

• Bachelor’s degree required.
• 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, cGMP knowledge, and production operations
• 5+ years in a Manufacturing/Operations in a cGMP environment is required
• An equivalent combination of education, experience, and training may substitute.
• Cell Therapy manufacturing experience preferred.
• Prior experience in a quality/manufacturing compliance role preferred
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to augment (M-F) shift to support development work at critical points.
• Must be able to work in a cleanroom environment.
• Must be comfortable working with human blood components.
• Must be able to be in close proximity to strong magnets.
• Must have experience in GMP Document writing and Change Control ownership.
• Must have Quality Systems Change Management experience (change controls, CAPA, document updates, etc.).
• Must be able to gown into controlled spaces and work on their feet for long durations.

Preferred Qualifications:

• Masters degree preferred.
• Experience in pharmaceutically regulated change management practices.
• Cell expansion using incubators and single use bioreactors.
• Direct experience with Process Development or Manufacturing Science and Technology teams.

PHYSICAL DEMANDS:

• Stand and Walk - Required to stand/walk while opera