Devens, MA, 01434, USA
5 days ago
(Night 6pm-6am)Lead Manufacturing Associate, Cell Therapy Manufacturing
**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 Cel l Therapy Manufacturing seeks Lead Associates within Manufacturing that bring 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 routine manufacturing operations for Cell Therapy. **R EQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:** **Education:** + 4 + years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience + Bachelors in relevant science or engineering discipline, or equivalent in work experience. **Experience** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + 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. Preferred Qualifications: + Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment. + Experience in the following preferred : Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas. + Cell expansion using incubators and single use bioreactors. **DU TIES AND RESPONSIBILITIES:** + Execute operations described in standard operating procedures and batch records." + Demonstrates strong practical and theoretical knowledge in their work + Complet es documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records." + Solves complex problems; takes new perspectives using existing solutions + Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. " + Completing training assignments to ensure the necessary technical skills and knowledge." + Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities." + Collaborates with support groups on recommendations and solving technical problems. + Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule. + Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status. + Supports investigations + Identifies innovative solutions + Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements" + Training others on SOPs, Work Instructions to successfully complete manufacturing operations." + Working wit h production planning with leadership to execute 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." **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. " 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 scienceā„¢ , 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/ (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. 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. **Company:** Bristol-Myers Squibb **Req Number:** R1584491 **Updated:** 2024-11-13 03:12:21.737 UTC **Location:** Devens-MA 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.
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