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Clinical Manufacturing Associate - job 1 of 2

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 Associates within Manufacturing that brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities, and direct manufacturing operations for Clinical Cell Therapy. 

**Monday - Friday, core business hours**

DUTIES AND RESPONSIBILITIES: 

  • Perform Clinical patient process unit operations and support operations described in standard operating procedures and batch records.  

  • Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.  

  • Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. 

  • Solves simple problems; takes new perspectives using existing solutions 

  • Completing training assignments to ensure the necessary technical skills and knowledge.  

  • Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.  

  • Training others on SOPs, Work Instructions to successfully complete manufacturing operations.  

  • Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.  

  • Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.  

 

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities: 

Education: 

  • High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience 

  • Bachelors in relevant science or engineering discipline is preferred 

Experience 

  • Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations. 

  • Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).  

  • Must be able to work in a cleanroom environment and perform aseptic processing  

  • Must be comfortable being exposed to human blood components.  

  • Must be able to be in close proximity to strong magnets.  

  • Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less. 

Preferred Qualifications:  

  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.  

  • GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.  

 

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-Onsite

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 to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to 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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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What You Should Know About Clinical Manufacturing Associate, Bristol Myers Squibb

Joining Bristol Myers Squibb as a Clinical Manufacturing Associate in Devens, MA, means becoming a part of a team that's dedicated to making a real difference in people's lives. Here, you'll engage in uniquely interesting work that challenges and inspires you every day. We are seeking individuals who are not only enthusiastic and intellectually curious but also eager to dive into the world of cell therapy manufacturing. As a Clinical Manufacturing Associate, you will play a crucial role in supporting clinical manufacturing operations, ensuring that we adhere to safety and quality standards in everything we do. Imagine performing clinical patient processes, assisting in manufacturing activities, and documenting essential protocols, all while growing your technical skills and knowledge. You'll have the chance to contribute to meaningful projects that transform patient care, and you'll do so in a collaborative environment filled with diverse perspectives. With a focus on both your personal and professional development, you can take your career farther than you thought possible. At Bristol Myers Squibb, we celebrate the importance of flexibility and balance, offering competitive benefits to support your overall well-being. If you are driven, ready to learn, and excited about the possibilities in bioprocessing manufacturing, this is an opportunity you won’t want to miss!

Frequently Asked Questions (FAQs) for Clinical Manufacturing Associate Role at Bristol Myers Squibb
What are the primary responsibilities of a Clinical Manufacturing Associate at Bristol Myers Squibb?

As a Clinical Manufacturing Associate at Bristol Myers Squibb, your primary responsibilities will include performing clinical patient process unit operations according to standard operating procedures, documenting process activities, and ensuring compliance with safety and quality standards. You will also engage in training assignments, assist in setting up manufacturing areas, support aseptic processing in a cleanroom environment, and work towards solving operational challenges effectively. This role is pivotal in supporting clinical manufacturing operations that impact patient care.

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What qualifications do I need to become a Clinical Manufacturing Associate at Bristol Myers Squibb?

To become a Clinical Manufacturing Associate at Bristol Myers Squibb, a high school diploma is required, along with 0-2 years of experience in cGMP bioprocessing or relevant fields. A bachelor's degree in a science or engineering discipline is preferred. Additionally, candidates should demonstrate a willingness to learn, the ability to work in a cleanroom environment, and knowledge of cGMP regulations is advantageous. The role also requires flexibility regarding shifts and the ability to transport to different BMS sites for training.

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What is the work environment like for Clinical Manufacturing Associates at Bristol Myers Squibb?

The work environment for Clinical Manufacturing Associates at Bristol Myers Squibb is dynamic and collaborative, set primarily within a cleanroom to maintain strict quality and safety conditions. You will be part of a high-achieving team where diversity is valued, and innovation thrives. The role demands attention to detail and adherence to stringent cGMP standards while providing you with opportunities for professional growth and development amidst challenging manufacturing processes.

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What is the work schedule for Clinical Manufacturing Associates at Bristol Myers Squibb?

Clinical Manufacturing Associates at Bristol Myers Squibb work Monday through Friday during core business hours, but candidates should be flexible to work various shifts, including nights, weekends, and holidays as needed. This flexibility ensures that manufacturing operations run smoothly and effectively, supporting the goals of clinical cell therapy production.

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What personal attributes will help me succeed as a Clinical Manufacturing Associate at Bristol Myers Squibb?

To be successful as a Clinical Manufacturing Associate at Bristol Myers Squibb, essential attributes include enthusiasm, intellectual curiosity, and a commitment to quality and safety. Being goal-oriented, adaptable to changing environments, and capable of executing assigned tasks efficiently are critical. Additionally, a collaborative spirit and the ability to communicate effectively within a team setting will greatly benefit your contributions to the manufacturing process.

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Common Interview Questions for Clinical Manufacturing Associate
How do you ensure compliance with safety and quality standards in manufacturing?

To ensure compliance with safety and quality standards, I prioritize training and familiarize myself with the latest standard operating procedures and regulations. I maintain a high level of attention to detail, regularly conduct safety checks, and engage in discussions with my team to uphold those standards rigorously.

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Can you describe your experience with cGMP regulations?

While I have some foundational knowledge of cGMP regulations through my education and limited work experiences, I am keen to deepen my understanding further. I have reviewed key guidelines and am eager to apply this knowledge practically while staying updated on trends and changes in the regulatory environment.

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What challenges do you anticipate in a cleanroom environment?

One significant challenge in a cleanroom environment is maintaining strict cleanliness protocols while performing various tasks. To adapt, I prioritize practicing aseptic techniques and consistent adherence to cleanroom entry and exit procedures. I also am aware of how to work collaboratively without compromising the environment.

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How would you handle unexpected problems during the manufacturing process?

In the face of unexpected problems during manufacturing, I would analyze the situation calmly, seeking input from team members to discuss potential solutions. Utilizing existing protocols as guides, I would aim to find a resolution while adhering closely to safety standards and documentation requirements.

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What do you think makes you a good fit for the Clinical Manufacturing Associate position?

I believe my enthusiasm for science, combined with my commitment to learning and developing in the manufacturing space, makes me a great fit for the Clinical Manufacturing Associate position. I am flexible, eager to collaborate with a diverse team, and dedicated to producing high-quality results that positively impact patient care.

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How do you prioritize tasks when handling multiple responsibilities?

I handle multiple responsibilities by assessing deadlines and the criticality of each task. I create a structured plan, listing tasks by priority, and adjust as necessary throughout the day. Communication with my team is crucial in balancing responsibilities effectively.

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What steps do you take to maintain quality in your work?

Maintaining quality in my work involves closely following standard operating procedures, regularly reviewing my outputs, and checking that all documentation is complete and compliant with all guidelines. I am also proactive in seeking feedback to continuously improve.

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Why is teamwork important in a clinical manufacturing setting?

Teamwork is vital in clinical manufacturing because it fosters collaboration, where team members can share insights and solve challenges collectively. Each role has interconnected responsibilities that require smooth communication and synergy to ensure operational success and, ultimately, better patient outcomes.

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How familiar are you with training others in standard operating procedures?

I understand the importance of training others in SOPs, and while I may not have extensive experience, I am highly enthusiastic about sharing knowledge. I believe that effective training ensures consistent quality and promotes a culture of safety and efficiency among team members.

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What motivates you to pursue a career in clinical manufacturing?

I am motivated to pursue a career in clinical manufacturing because I am passionate about contributing to life-changing therapies. The prospect of working on innovative solutions in patient care energizes me, and I am drawn to the idea of being part of a dedicated team at Bristol Myers Squibb that transforms lives through science.

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Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

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Full-time, on-site
DATE POSTED
April 4, 2025

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