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Manager, ECQ Operations

4 months ago

Summit, United States Bristol Myers Squibb Full time

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.

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 Manager, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufacturing operations at a multi-product site through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role manages entry, junior, and experienced level professionals providing support across 2 Quads covering 24hrs/day 4 days per week at the Summit West S12 CAR-T Manufacturing Facility, tasked with performing on demand, preventative maintenance, calibration and performance verification activities of equipment according to established policies and procedures. In addition to answering questions and resolving issues for staff, the incumbent spends a portion of their time on individual work or improvements. The incumbent may lead modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.

Shifts Available:

Wednesday - Saturday, 8am – 6pm

Responsibilities:

Lead a team of up to 10 people including full time and contract personnel. Interview and hire internal and / or external personnel to fill necessary roles. Provide direction to internal and external team members. Manage the workload of team members to ensure appropriate work life balance. Delegate, develop and motivate direct and contract reports. Deliver personnel performance reviews. Ensure team members are appropriately trained for duties being performed.  Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines. Ensure the team is in full compliance with local, site and global Celgene policies and procedures.  Directly supervise Equipment Commissioning & Qualification operations staff including the scheduling, execution, and documentation of calibration, maintenance, repair, and equipment performance verification activities in both laboratory and manufacturing areas in Summit facilities. Review and approve calibration, maintenance, repair and performance verification records for accuracy, completeness and compliance to Celgene standards. Supports or leads investigations into deviations and performance verification failures, and develops and implements corrective and preventive actions Ensures compliance with Validation Master Plans. Coordinates and supervises vendors for preventative maintenance, calibration and performance verification functions. Develops and reviews written procedures for calibration, preventive maintenance and performance verification of equipment. Maintain the calibration management system in a validated state.  Assist with the creation of departmental metrics. Understand and review departmental metrics.  Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests. Provides technical support and guidance on calibration, equipment performance verification and validations issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.  Work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. Assist with the management of Vendor service contracts to support equipment and systems. Provide feedback to departmental leadership on vendor performance and needs. Ensure equipment maintenance programs are maintained in compliance. May be called upon to act as SME in both internal and regulatory audits.

Knowledge & Skills:

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. Ability to develop, delegate and motivate others including direct and indirect reports. Understanding of scheduling fundamentals and execution. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business. Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM. Ability to create and analyze meaningful metrics.

Basic Requirements:

BS in Engineering or Science related discipline preferred. Minimum 7 years’ experience in FDA-regulated industry Minimum 5 years’ experience working directly with bench top manufacturing and laboratory equipment (cell counters, liquid handlers, Flow Cytometry, etc.) required. Knowledge of cGMP in the pharmaceutical industry Excellent computer skills including knowledge of calibration management and environmental monitoring systems Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently. Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required 3 years of maintenance coordinating / planning experience, preferably in a laboratory environment. Experience working in a commercial environment preferred.

Working Conditions:

Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs Ability to sit, stand, walk and move within workspace for extended periods Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling. Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes. Ability to work safely and effectively when working alone, or working with others.

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

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

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 . Visit 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.