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 .

　　Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

　　The Associate, Manufacturing Technical Services will collaborate with internal Manufacturing partners, such as but not limited to MS&T (Manufacturing Science & Technology), Warehouse, EHS and Quality groups to support the completion of improvement actions (No Impacts, CAPAs, Change Control Actions and Document updates).

　　Additionally, the Associate is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information. The associate with support No Impact Deviations.

　　The Manufacturing Records and Procedures Associate will also be responsible for working with the MO and QA teams on CAPAs and Change Control Actions as needed and ensure on time implementation, effectiveness checks and closure of actions. Associates will write, revise, and review all related GMP documentation for S12 CAR T manufacturing records and procedures including SOPs and Work Instructions.

　　Associates will review manufacturing batch records and any/all records used at the CAR T manufacturing and testing facilities.

　　Shifts Available:

　　TBD

　　Responsibilities:

　　Deviations

　　Attend alignment meetings, evaluate and provide feedback on severity classification.

　　Able to handle no Impact deviations, which require rapid turnaround.

　　Ability to create and/or review already created QMS deviations, provide feedback when needed, and ensure timelines are met.

　　CAPAs

　　Responsible for opening CAPAs as needed to revise, SOPs, Work Instructions, to support new product/process implementation.

　　Ability to complete CAPA Actions as needed within QMS.

　　Ability to complete effectiveness checks that may require historical reviews or spot checks as needed.

　　Responsible for on-time closure of CAPAs and Effectiveness Checks.

　　Ability to work cross-functionally to make necessary updates to procedures/documents to address procedural gaps.

　　Change Controls

　　Ability to complete change control actions within EQMS as needed.

　　Ability to work cross-functionally to make necessary updates to procedures to address procedural gaps and/or new processes implementation.

　　Responsible for on-time closure of Change Controls Actions.

　　Continuous Improvement

　　Ability to support continuous improvement initiatives.Manufacturing Operations Batch Record Review (MOBRR)

　　Some knowledge or experience in cGMP Manufacturing, Compliance or Quality

　　Reviews executed batch records for documentation completeness and accuracy.

　　Aims for Right First Time (RFT) to avoid missed corrections.

　　Performs other assigned duties as may be required to meet company objectives.

　　Possesses strong attention to detail.

　　Possesses good written and oral communication skills.

　　Proficient in MS Outlook, Word, and Excel.

　　Possesses strong interpersonal skills and the ability to work well in a team environment.

　　Possesses good time management skills and can coordinate multiple tasks efficiently.

　　Required for all job functions

　　Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to verify the correct reviewers/approvers are selected.

　　Ensuring on time review/approval/effectiveness.

　　Other duties may be assigned, as necessary.

　　Knowledge & Skills:

　　Must have knowledge of cGMP manufacturing, Quality, FDA and compliance.

　　Knowledge of US and global cGMP requirements.

　　Must possess an independent mindset.

　　Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

　　Builds relationships internally within and with cross functional teams.

　　Contributes to goals within the work group.

　　Able to recognize conflict and notify management with proposed recommendations for resolution.

　　Able to prepare written communications and communicate problems to management with clarity and accuracy.

　　Able to effectively multi-task.

　　Excellent verbal and written communication skills.

　　Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products

　　Knowledge of cGMP/FDA regulated industry

　　Basic mathematical skills

　　Strong technical and compliance writing capability

　　Proficient in MS Office applications

　　Background to include an understanding of biology, chemistry, medical or clinical practices

　　Basic Requirements:

　　Bachelor’s degree with ability to learn Manufacturing Technical Writing skills.

　　OR Associate/ Medical Technical degree and 1-2 years of Manufacturing or Operations experience

　　OR High School diploma/GED and 2 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA role.

　　Working Conditions:

　　Employees are required to be available every day on site unless stated by your manager. In our shared office space, designated seating arrangements are available for all Specialists. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize your efficiency and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. It is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training.

　　Although position is primarily office based, some on floor/clean room interactions may be required. Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals and exposure to sanitization agents could be expected. Potential exposure to human blood components and strong magnets. Designated clean room areas will prohibit food, any outside materials such as cell phones, tablets, at a minimum.

　　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 or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

　　If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

　　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

　　Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

　　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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

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

　　Company: Bristol Myers Squibb

　　Req Number: R1577781

　　Updated: 2024-01-18 23:06:31.009 UTC

　　Location: Summit,New Jersey

　　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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.