Bristol-Myers Squibb Company

Manager, Quality Control Technical Support (QCTS) Bioassay

Location
Devens, MA, US
Posted
May 12, 2018
Ref
R1504636
Required Education
Bachelors Degree
Position Type
Full time
Reporting to the Associate Director, QC Technical Support, the QCTS Bioassay Manager role will be responsible for leading a team of SMEs/analysts responsible for the technical transfer, troubleshooting, and technical documentation related to bioassay / immunologic-related assays. The QCTS Bioassay Manager may also perform other duties and participate on a variety of network teams (technical/ strategic) in support of business processes/ improvements.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Manage the Scientists and QC Specialists participating in method technical transfers/ validations for bioassay and other immunological assays (e.g., ELISA).
  • Participate on a variety of network teams (technical/strategic) in support of business processes/ improvements.
  • Manage data review, trending analyses and prepare protocols and reports to support the bioassay/immunoassay QC labs.
  • Provide support for investigation/trending program for area related QC events and data.
  • Ensure cGMP compliance in all aspects of laboratory operations.
  • Develop and implement SOPs for various Quality Control operational procedures including but not limited to: training, trending, equipment maintenance and calibration, method execution, investigations, and laboratory processes.
  • Recruit and develop a high performing team with diverse backgrounds and talents. Coach and counsel team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
  • Maintain and communicate performance metrics for her/his team, setting and maintaining high expectations for team performance.
  • Develop and drive staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.
  • Provide technical guidance to QC and serves as Subject Matter Expert in cross functional, cross departmental work teams.
  • Perform review of regulatory dossiers as on needed basis.
  • Identify and drive business improvement projects on site and in network.


KNOWLEDGE AND SKILL:
  • Knowledge of science generally attained through studies resulting in a B.S./ M.S. in science (molecular biology, chemistry, biochemistry, a related discipline or its equivalent) is required.
  • A minimum of 6 years (MS)/ 8 years (B.S.) experience in biopharmaceutical quality with a minimum of 4 years of laboratory management responsibility.
  • Strong background and demonstrated effectiveness with method validation transfer for biologics methodology.
  • Extensive knowledge of US and EU cGMP regulations and guidance.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of applicable business systems including: SAP, LIMS, Trackwise and laboratory EDMS.
  • Experience with regulatory agency (FDA, EMEA, TGA) inspections required.
  • Strong working background in QC laboratory systems and applications including LIMS sample manager, Smartlab ELN, and their integration to other systems.
  • SME of the Quality system to understand impact of changes to these systems and their integration.


CONTACTS:

Incumbents have daily interaction with their subordinates and other members of the site Quality organization. This role has business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Automation, Technical Services, EHS and Manufacturing staff. Less frequent contact with general business functions including human resources, and Finance and BMS staff at other locations, including corporate headquarters. Occasional contact with outside vendors and contact with representatives from health authorities / regulatory agencies during site audits.

WORKING CONDITIONS:

Work is largely performed in a modern office and a cGMP laboratory / manufacturing facility where one must maintain a high attention to detail and to be aware of the presence of workplace hazards including pressurized liquids gases, steam, biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required the laboratories and in some portions of the facility.

DECISION MAKING:

Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment with in generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates Scientist/ QC Specialist accordingly. Establishes and recommends changes to policies which affect subordinate organization. Develops a coaching and mentoring environment for subordinates that fosters open communication. Works with peers to ensure alignment of priorities and agreement of project ownership.

SUPERVISION RECEIVED:

Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with establishes policies. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.

SUPERVISION EXERCISED: Directly: 3 - 6 exempt; up to 2 - 4 non-exempt.

Travel Required: Up to 10%