Sr. Biologics Manufacturing Project Specialist
Location:
Posted:
October 22, 2016
Reference:
1604500
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

The Bristol-Myers Squibb Devens site is a state-of-the-art biologics manufacturing facility located on 89 acres, just 45 minutes west of Boston. It is here that we will be fulfilling our critical mission to help patients prevail over serious diseases. This 400,000 square foot complex represents the single largest capital investment in the nearly 125 year history of BMS, $750 million, and is a key part of our strategic BioPharma transformation.

Responsibilities:
  • To support manufacturing by managing issues list and providing cross functional visibility to issues identified on the floor
  • Provide support to manufacturing for both upstream and downstream process
  • Responsible for management of ideas, issues, change initiatives that come from the floor, ideas bank, Tier meetings, CAPA, safety projects, or yellow belt initiatives
  • Actively manage the change control process; work closely with change owners (Project Lead and/or Manufacturing Engineering) to develop change schedule and ensure schedule adherence to schedule
  • Develop and report Metrics related to change control
  • Work closely with Manufacturing Engineering and Project Lead managers to understand resource capacity with regard to change ownership and initiation
  • Own and drive prioritization of site change initiatives working closely with Quality, Engineering, Manufacturing, MS&T and Technical Services as needed
  • Ensure alignment on prioritization tools, and effectively communicate prioritized items
  • Maintain and manage manufacturing issues database
  • Attend daily schedule meeting, tier meetings, or other governance meetings to ensure all items are properly captured
  • Work with Safety and CAPA Huddle to understand complete book of work required to support manufacturing
  • Works closely with Engineering Manager and project Lead manager to ensure alignment of priorities and resources, and to assist with resource loading and estimation

Qualifications:
  • Knowledge of manufacturing engineering and science generally attained through studies resulting in a B.S., in engineering (Chemical or Mechanical preferred), a related discipline, or its equivalent
  • A minimum of 6 years relevant experience (or equivalent) in biopharmaceutical industry or its equivalent including experience with manufacturing equipment support in the Biotechnology manufacturing industry
  • The individual should have the ability to execute multiple complex technical projects and have some familiarity with the manufacturing operations of large scale production facilities as well as GMP experience
  • Knowledge of engineering principles related to typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers
  • Demonstrated effectiveness in both a team environment and an individual contributor role
  • Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability
  • Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting
  • Strong project management skills/experience desired.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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