Job Description Summary

Job Summary:

Reporting to the Site Director, the incumbent is responsible for maintaining/ establishing the Lab facility of BD TCI and upkeep including forecasting, scheduling, and assignment of daily lab tasks working closely with the Lab Technicians from other Business platforms. The Lab Manager is also responsible for development and preparation of performance metrics.
Additionally, the Lab Manager is responsible for identifying, planning, scheduling, and executing lab improvement projects.

Job Description

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

About BD TCI

“BD, a 125-year-old global medical device company has started its Enterprise Center in Bangalore, India called BD Technology Campus India (TCI). This Enterprise Center will be an integral part of the global network for BDX. It will have presence of R&D, Quality, Regulatory, IT and other functions. The center boasts of some of the brightest minds who work in a unique environment that fosters and supports ingenuity. BD TCI is dedicated to serving BD’s customers and patients thereby contributing its bit towards “advancing the world of health”.

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

The Lab Manager is an individual contributor role working with cross functional BU’s/ platforms to support them in the Design Verification Tests, Feasibility testing etc.

• Set up the expansion of the current Laboratory based on requirements that may come up in BD TCI
• Work with global counterparts to understand the various test requirements and specific Lab Certifications (ISO/FDA) and recommend capabilities to be developed in BD TCI.     
• Meets with all R&D project teams (across Platforms) to receive testing forecasts
• Works closely with different platforms and their lab team to ensure smooth operations of the lab
• Manage end to end Budget for the LAB
• Understanding of QMS, Defect management procedures and EHS (environmental health and safety) requirements and ensures strict compliance.
• Coordinates and ensures Calibration / Preventive Maintenance / repair schedule with adequate documentation
• Maintains all relevant documentation and presents as needed for quality Audits.
• Clear understanding of FAI and IQ/OQ/PQ.
• Fields testing needs forecasts and requests from non-project sources (e.g QA, Marketing, TMD,etc)
• Addresses inconsistencies on test needs/requests with requestors
• Converts incoming individual test needs into test requests within the lab tracking systems
• Translates forecasts into daily schedules and hosts a daily shift startup meeting
• Adjusts daily schedules for emergencies
• Identifies gaps and improvement needs within the lab
• Develops goals and project plans based on identified needs
• Creates corresponding schedules and work assignments for project completion
• Executes Continuous Improvement projects in the following (but not limited to) areas
  • Equipment or method troubleshooting/repairs
  • Coordinates with Test Method Development and Verification & Validation team for equipment and method validations
  • Method or Equipment Upgrades
  • Fixture maintenance
  • Drawing or Specification modifications
  • Adopt Automation initiatives
• Creates ACR/ECR for Changes generated from CI projects
• Maintains the Tool Crib and Fixture inventory
• Addresses concerns / issues from project teams regarding test results or equipment/method inconsistencies
• Maintains metrics that demonstrate measurable improvements
• Maintains good laboratory practices (GLP) consistent with MDS product development objectives and regulatory guidelines.
• Participates as primary contact for Lab related questions during audits
• Performs other duties as required.
• Proficiency in Microsoft Project or equivalent project planning software
• Demonstrated versatility and learning agility and Team oriented.
• Basic understanding of business / finance concepts (e.g. payback, rate of return, cashflow, income statement, etc.)

Education and Experience:

• Bachelors in relevant field is required (i.e. Mechanical/ Materials/ Chemical/ Industrial) or any other advanced degree. Minimum experience of 8+ years (not more than 12 Years) with 5 years of direct laboratory management experience and a minimum of 2 years of supervisory experience.
• Experience with managing labs related to medical devices.

Knowledge and Skills:

• Knowledge of the operation of mechanical measurement equipment (e.g. Instron) desirable.
• Operation of diagnostic instrumentation desirable.
• Superior communication skills, both written and oral.
• Knowledge of computer programs
• Knowledge of statistical analysis desirable.

Physical Demands: (if applicable)

Work Environment: (if applicable)

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift