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Manufacturing Lead, CAR T Media Preparation, ide-cel Manufacturing Operations
Summit West, S12
PURPOSE AND SCOPE OF POSITION:
The Manufacturing Lead is responsible for assisting the Media Supervisor with shift management, direction and coordination of production personnel, processes, schedule, and is expected to maintain a compliant, effective, safe and efficient operation. The expectation is that the Lead actively performs routine manufacturing activities in a controlled, cleanroom environment while assuring proper execution of production activities within manufacturing are being performed following all cGMP's and SOP's. The Lead will be the acting supervisor, working closely with the Media Manager in the absence of a supervisor (vacation, sick time, etc.). This position is for the Weekday Shift Monday through Friday with shift coverage from 12:00 am to 8:30 am (Shift 3). Start and end times are subject to change based on business demands.
This position is for the Manufacturing Organization.
Pre-requisites: This position requires Senior Manufacturing Associate or equivalent experience.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Understanding of media and solution preparation requirements for cell culture, and aseptic processing and/or lab techniques.
Advanced proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
Familiarity with cGMP/FDA regulated industry.
Basic mathematical skills.
Ability to read, execute and document steps in a GMP batch record.
Technical writing capability to support batch record revisions, deviation investigations, and closure of CAPAs.
Proficient in MS Office applications.
Advanced written and verbal communication skills.
Enforce and sustain all safety guidelines
Education and Experience:
Bachelor's degree and 2-4 years of experience in pharmaceutical manufacturing
or Associate/Medical Technical degree and 6+ years of experience in pharmaceutical manufacturing
or High School diploma/GED and 8+ years of experience in pharmaceutical manufacturing.
DUTIES AND RESPONSIBILITIES:
Provides effective floor level leadership to the Manufacturing function.
Consistently projects a positive attitude and example for other department team members.
Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
Trains and mentor's department personnel to the tasks that are performed within their assigned department.
Continuous Improvement Champion open to change and implementation of ideas brought forward by operators.
Facilitate execution of these ideas and develop the team while doing so.
Openly communicate with operators and management to ensure employees have the resources needed to meet or exceed their goals.
Work with management to ensure adequately trained personnel are available to perform all manufacturing activities.
Maintain manufacturing areas that are compliant, efficient, effective and safe.
Participate in shift exchanges of information to ensure seamless operations.
Other duties may be assigned, as necessary.
WORKING CONDITIONS (US Only):
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to push, pull, reach, balance, and/or lift greater than 20 lbs.
Sufficient vision and hearing capability to work in a cleanroom environment.
Must have the ability to work around controlled, enclosed and restricted cleanroom environments with assigned air pressure and temperature conditions.
Cleanroom garments and personal protective equipment will be required in designated areas which may 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.
Use of reagents, chemicals, and exposure to sanitization agents are expected.
Ability to work in the vicinity of strong magnets is required.
Designated areas may prohibit food, any outside materials such as cell phones or 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Bristol Myers Squibb