Manufacturing Associate liso cel CAR T

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose and Scope of Position:

Manufactures human blood derived components per Standard Operating Procedures (SOPs) 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. Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday. Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands.

Duties and Responsibilities:

Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.

Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift.

Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.

Weighs and measures in-process materials to ensure proper quantities are added/removed.

Adheres to the production schedule ensuring on-time, internal production logistics.

Records production data and information in a clear, concise, format according to proper GDPs.

Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.

Works in a team based, cross-functional environment to complete production tasks required by shift schedule.

Motivated, team consciousness individuals are needed to fulfill job requirements.

Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead.

Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.

Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Required Competencies:

Knowledge/ Skills, and Abilities:

Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique

Knowledge of cGMP/FDA regulated industry

Basic mathematical skills

General understanding of cGMPs

Technical writing capability

Proficient in MS Office applications

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

Education and Experience:

Bachelor’s degree

or Associate/ Medical Technical degree and 3 years of Manufacturing or Operations experience

or High School diploma/GED and 2 years of Manufacturing or Operations experience.

Working Conditions:

Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.

Must be comfortable working with contained human blood components.

Physical dexterity sufficient to use computers and documentation.

Sufficient vision and hearing capability to work in job environment.

Ability to lift 25 pounds.

Must have the ability to work around laboratories and controlled, enclosed, restricted areas.

Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.

Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.

Flexibility to don clean room garments and personal protective equipment (PPE).

Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.

Routine exposure to human blood components. Exposure to strong magnets is likely.

Designated areas may 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.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com