Bristol-Myers Squibb Company

QC Manager, Bioanalytics

Location
Syracuse, NY, US
Posted
Oct 10, 2018
Ref
R1510114
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
The Syracuse Quality Control (QC) Laboratories support the onsite commercial manufacturing facility, as well as network and third party manufacturing facilities. The Manager coordinates and provides oversight to activities related to the test of release, stability, and in-process samples for Syracuse Quality Control. The Manager supervises laboratory and/or project work activities for staff analysts. They perform laboratory duties in accordance with cGMP regulations and departmental procedures. The Manager is also responsible to drive operational excellence activities to continually improve laboratory efficiency.

Duties/Responsibilities:
  • Applies knowledge and in-depth understanding of analytical techniques within and outside of their specific group
  • Manages work schedules for sample analysis for release, stability and in-process testing
  • Ensures sample testing deadlines are met and tracks due dates through completion to meet or exceed metrics
  • Accountable for results generated by their respective testing teams
  • Oversees Change Controls and Laboratory Investigations within their teams
  • Reviews and approves analytical instrumentation qualification calibration, repairs and documentation
  • Ensures method performance and sample data trending is kept up to date
  • Maintains cGMP compliance within their laboratories
  • Generates, revises, and/or approves SOP or test methods
  • Reviews and ensures training requirements are completed and maintained for analysts and self
  • Maintains a safe working environment in the laboratory and participates in safety and compliance inspections
  • Supports regulatory inspections and audits
  • Provides leadership, direction, and communication of business critical information to staff
  • Supports Lean Laboratory scheduling


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:
  • Applied knowledge and in-depth understanding of GMP Quality Control systems
  • It is preferred the candidate have analytical experience with ELISA, PCR, cell-based bioassay, gel electrophoresis, and/or B7
  • 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
  • Contribute to a team based, collaborative environment promoting candor, clarity of purpose and high commitment to business goals.


Education/Experience/ Licenses/Certifications:
  • BS degree in scientific area with a minimum of 10 years' experience, MS with 4 years' experience or PhD with limited or no experience and demonstrated theoretical understanding of scientific area of study
  • Six Sigma and/or Lean Practitioner training/certifications preferred


Physical Demands:

This position is primarily office-based work that routinely requires sitting for extended periods of time at computer workstations. Walking between and within buildings to collaborate with others and oversee areas of responsibility is required. This position also involves entry into lab spaces which require appropriate levels of personal protective equipment (PPE). Repetitive arm, hand, and finger movements for computer work are required.

Work Environment:

This position is based indoors primarily working with others, however, also independently and alone at times.

Travel:

This position does not routinely travel however minimal travel may be needed (

Supervisory Responsibilities:

This position requires supervision of personnel.