Manager, Ecq Operations - Summit, United States - Bristol-Myers Squibb

Mark Lane

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Mark Lane

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Description

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:


  • Management 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.
  • Operational Activities _
  • 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.
  • Promotes and provides excellent customer service and support_
  • 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.
  • Inventory Management_
  • Work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
  • Service Contract Support_
  • Assist with the management of Vendor service contracts to support equipment and systems.
  • Provide feedback to departmental leadership on vendor performance and needs.
  • Regulatory Responsibilities_
  • 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

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