Manager, Material Operations, Cell Therapy (Technical)

BioSpace
Devens, MA Full Time
POSTED ON 6/5/2024 CLOSED ON 7/3/2024

What are the responsibilities and job description for the Manager, Material Operations, Cell Therapy (Technical) position at BioSpace?

Working with Us

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.

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. Read more: careers.bms.com/working-with-us.

Position Summary

This position is responsible for assisting Senior Management drive changes within Material Operations and Warehousing, while ensuring a constant state of compliance within core business operations in the warehouse. This role serves as a subject matter expert for Warehousing and Material Operations and associated SAP transactions. The role interfaces with Incoming QA and other partner organizations to design and improve new and existing processes as our business landscape evolves and scales up. A core expectation of this role is a proven ability to excel and navigate change in a complex regulatory environment within the new and exciting Cell Therapy industry.

Duties/Responsibilities

  • Subject Matter Expert (SME) and process owner for relevant SAP transactions as they pertain to material receipt, movement, replenishment, and issuance
  • Ensure comprehensive and well-thought-out approach to change management and impact assessment for local and global change controls as they pertain to warehousing and material management.
  • Change Control Record initiation and ownership for changes raised within Material Operations
  • Represent department as SME during regulatory audits as needed
  • Open and investigate deviations and assist in robust CAPA development and execution as needed
  • Monitor and manage controlled-temperature units (CTUs) to ensure alarms are reviewed and acknowledged appropriately and that service is current for all units within our scope of control
  • Identify and implement process improvements at site and interface with other sites within the commercial Cell Therapy network to build relationships and improve site-to-site processes
  • Collaborate with partner organizations including but not limited to Incoming QA and Inventory Management to develop and improve upon workflows and communication
  • Support both core business operations and project execution in a fast-paced environment


Qualifications

  • Post-secondary education resulting in an Associates or Bachelors Degree in a relevant discipline
  • 5 years of relevant experience. An equivalent combination of education, experience, and training may substitute
  • Experience within an FDA approved commercial facility. Knowledge and understanding of GMP and compliance within a commercially approved facility in a regulated industry. Experience within the Biotech / Cell Therapy space is preferred.
  • SAP system knowledge and experience. A specialization in Extended Warehouse Management (EWM) is preferred
  • Demonstrated experience and excellence in change management and impact assessment with the Quality Management System. Experience with Infinity is preferred
  • Demonstrated experience and excellence in investigating and documenting deviations and CAPA within the Quality Management System. Experience with Infinity is preferred
  • Proficiency in technical writing with a focus on new document creation and document revision. Experience with SOP, risk assessment, and work practice documentation is preferred
  • Basic knowledge and experience with controlled temperature units such as cold-rooms and freezers in addition to experience with process automation system (PAS) temperature and alarm monitoring. Experience with DeltaV and asset management system such as Maximo is preferred.
  • Microsoft Office Applications such as Outlook, PowerPoint, Excel, and Word
  • Ability to work independently and as part of a team
  • Experience with facilitating training is preferred
  • Experience with project management skillsets and tools including but not limited charters and matrix team leadership


BMSCART

If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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

Responsibilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

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