Principle Clinical Manufacturing Specialist - Bristol Myers Squibb

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.

PURPOSEAND 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 operating manufacturing/computer equipment for several hours at a time, throughout the day. 
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials. 
• Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day. 
• Bend and Kneel - Required to bend or kneel several times a day. 
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day. 
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day. 
• Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day. 
• Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day. 
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection. 

BMSCART

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries toadastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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