Manager, Manufacturing Project Lead

Bristol Myers SquibbDevens, MA
Hybrid

About The Position

Manufacturing Support Project Leads drive the initiation, management, and implementation of change initiatives that impact Manufacturing Electronic Batch Records. Project Leads act as the voice of manufacturing operations in tech transfers, lead complex manufacturing-owned projects such as Product Changeover, and support investigations and troubleshooting in relation to manufacturing automated systems.

Requirements

  • B.S. in science, engineering or related discipline is required.
  • A minimum of 4 years process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
  • Knowledgeable in multiple facets of biologics technical development, manufacturing, and quality
  • Proven track record of success in biologics technology, technology transfer, process development, and manufacturing operations support.
  • Demonstrated ability to successfully prioritize multiple activities, including people, business processes and projects.
  • Demonstrated ability to drive for results and lead innovations
  • Excellent matrix leadership skills with the ability to motivate and manage a team with dotted-line reporting relationship.
  • Adaptable to a fast paced, complex, and ever-changing business environment.
  • Ability to effectively communicate verbally and in writing, with cross-functional groups to achieve effective and timely results.

Nice To Haves

  • Experience in Lean, Yellow Belt, Agile, Tiers, Six Sigma or other operational excellence methodologies is preferred.
  • Proficiency with Syncade and DeltaV, and experience with process analytics trending tools, Trackwise, Infinity, Maximo, and SAP preferred.

Responsibilities

  • Acts as the voice of manufacturing operations in the change control process.
  • Owns the initiation, management, and closure of complex change initiatives
  • Provides user requirements in the form of functional specifications, user requirements, or other documentation.
  • Leads cross-functional teams to complete projects within agreed-upon timelines.
  • Interfaces frequently with Manufacturing shifts to provide change communication management and training
  • Utilizes Service Now and Infinity to perform change management tasks.
  • Understands and participates in site business processes for change management systems.
  • Works to continuously improve change management process
  • Effectively estimates resource and timelines for cross-functional activities.
  • Provides Manufacturing Operations technical support for electronic batch records
  • Participates in daily cross-functional meetings and other technical forums to provide support and input.
  • Authors and reviews CAPAs, procedures and instructions.
  • Leads and owns safety and compliance investigations and risk-assessments.
  • Supports technical transfer of new products as SME of process and Syncade recipes.
  • Participates in equipment design discussions, consumable needs, Facility Fit, and owns Syncade functional specifications.
  • Provides direct audit support.
  • Owns and drives a program-level initiative such as: Leads and improves Product Changeover
  • Acts as departmental lead in Tech Transfers
  • Leads P2 and P3 projects.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
  • Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
  • All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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