Bristol-Myers Squibb Company

In-Process Laboratory Lead - Night Shift

Location
Syracuse, NY, US
Posted
Nov 29, 2018
Ref
R1511117
Required Education
Bachelors Degree
Position Type
Full time
The In-Process Laboratory (IPC) Lead performs Quality Control testing for in-process, release, stability, and water in a cGMP environment, supports routine data analysis, OOS, OOT, and OAL investigations, and demonstrates knowledge of scientific techniques and practices within area of study. The IPC Lead will provide a direct point of contact for the IPC team to direct and support critical testing and result reporting to support the Syracuse site.

Duties/Responsibilities:
  • Proficient user of IPC instrumentation and related computer systems
  • Responsible for ensuring all lab activities are carried out to highest standards of GMP and EHS compliance
  • Responsible for ensuring the execution of scheduled standard work and reporting of issues within the laboratory to both Manufacturing Shift Managers and QC Management
  • Responsible for adherence to lean scheduled testing and support activities
  • Responsible for attending shift Tier huddle and communicating back to team members
  • Responsible for managing Tier 1 board in SQC IPC area to drive key performance indicators (KPIs), issues resolution, and communication across the shifts
  • Drives inter-shift communication to ensure employees know what is required from shift to shift
  • Supports implementation of projects and new technology
  • Performs instrument performance checks and calibration
  • Demonstrates familiarity with scientific technique and practices within area of study
  • Demonstrates the highest level of good documentation practices and instructs others with less experience on the best documentation practices
  • Assists with the generation or revision of SOPs as required and recognize when a new SOP is required to maintain compliance
  • Demonstrates on-going proficiency in the performance and theoretical understanding of a broad range of assays
  • Assists with Lean scheduling for IPC team
  • Assists with championing OPEX principles in the In-Process lab including standard work, 5S, visual management, human error reduction and tier meetings
  • Enhances Lean practices within lab for continuous improvements to efficiency.
  • Recognized by less experienced QC scientists as in-house expert user of instrumentation and related computer systems in area of responsibility.
  • Accountable to ensure all staff are trained and proficient on assigned specific method and techniques
  • Performs basic troubleshooting of instrumentation.
  • Trains and assists less experienced scientists within area of expertise with assay execution
  • Execute and assist in technical transfer and co-validation activities after demonstrated proficiency in assay execution.
  • Performs data review based on demonstrated proficiency in execution and/or reviewer training.
  • Able to recognize atypical results and trends within the realm of experience and training and follow-up needed.


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:
  • Previous hands-on training and GMP experience within the laboratory setting.
  • Advanced applied knowledge and depth of understanding of analytical techniques.
  • Proficiency in the performance of analytical methodology
  • Strong understanding of safety hazards and best practices for safe working conditions
  • Qualified trainer with ability to successfully coach and mentor individuals on lab practices and techniques
  • Ability to create an environment of trust, compliance, safety, continuous improvement and learning
  • Ability to work across the matrix to direct and support critical functions
  • Problem solving, decision making and communication skills


Education/Experience/ Licenses/Certifications:
  • Minimum BS degree in scientific area with 5 years of related experience or MS/PhD degree with limited or no experience (0-1 years of relevant experience).
  • Demonstrated theoretical understanding of scientific area of study and ability to train others.
  • Demonstrated problem solving ability, interpersonal, oral and written communication skills.
  • Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
  • Demonstrated contributions to a team based, collaborative, and positive environment, clarity of purpose and high commitment to business goals.
  • Adaptable to a fast paces, complex and ever-changing business environment
  • Effective verbal and written communication skills with technical writing skills


Physical Demands:
  • Vision (Acuity, color-correction allowed.)
  • Reaching (Shoulder)
  • Repetitive (Use of Arm, Hands, Wrists)
  • Unassisted lifting of items, not to exceed 50 lbs
  • Bending/Stooping


Work Environment: (

This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE).

This role will require:
  • Contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics.
  • Powdered materials and high temperature liquids and solids may also need to be handled.
  • Use of instrumentation that includes lasers may be required.
  • Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required.
  • This role also requires frequent unassisted lifting (not to exceed 50 lbs).
  • Repetitive use of arms/hands/wrists and grasping is also required.
  • Depending on the work demands, office-based work requires sitting.
  • This position is based indoors and primarily requires working with others, but also independent/alone work at times.
  • This position is a team-based position that requires shift work, weekends, and holidays.


Travel:
  • This position requires up to 5% of travel