Manufacturing Associate- CAR-T
Bristol Myers Squibb
Summary
Our Manufacturing Associate, CAR-T team manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.
Job description
Shift Available: Sunday - Wednesday (with e/o Wednesday off), Onsite Day shift, 5 a.m. - 5:30 pm.
Responsibilities
- Create inclusive culture that builds relationships with support groups
- Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)
- Executes transactions and process in all electronic systems and adheres to business continuity processes
- Prioritizes safety of self and others
- Reports safety events within 24 hours
- Immediately escalates any/all issues that may impact compliance or safety of self and/or others
- Complete documentation required by Source Governing Documents contemporaneously
- Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+
- Complete training assignments prior to assigned due date to ensure necessary technical skills and knowledge
- Train for proficiency in process systems and some supporting business systems
- Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
- Work within a control cleanroom environment and execute aseptic processing procedures (as assigned)
- 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
- Continues to refine and improve manufacturing process technique to improve individual operational times
- Verifies training completion prior to performing any GxP tasks
- Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements
Knowledge & Skills
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
- Background to include an understanding of biology, chemistry, medical or clinical practices
Basic Requirements
- A minimum high school diploma and/or equivalent is required.
- An associate or bachelor's degree in a related field is preferred
- 0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
Working Conditions
- Must be able to stand/walk for extended periods of time
- Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection
- Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
- Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
- Work in areas that may have strong magnets
- Must be able to work in a BSL2 / ML1 work environment handling human blood components
- Work in areas with exposure to vapor phase liquid nitrogen
- Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays
Requirements
- A minimum high school diploma and/or equivalent is required.
- An associate or bachelor's degree in a related field is preferred
- 0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
- Knowledge of cGMP/FDA regulated industry
- Basic mathematical skills
- General understanding of cGMPs
- Technical writing capability
- Proficient in MS Office applications
- Inventory control and/or management
- Background to include an understanding of biology, chemistry, medical or clinical practices
- Must be able to stand/walk for extended periods of time
- Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection
- Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
- Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
- Work in areas that may have strong magnets
- Must be able to work in a BSL2 / ML1 work environment handling human blood components
- Work in areas with exposure to vapor phase liquid nitrogen
- Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays
Benefits
- Wellbeing support
- Retirement benefits
- Financial protection benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Paid volunteer days
- Summer hours flexibility
- Leaves of absence
- Global shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.