QC Manager Bioanalytics

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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 (<10% of travel).

Supervisory Responsibilities:

This position requires supervision of personnel.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com