Bristol Myers Squibb Associate Director, Quality Control Release and Stability in Devens, Massachusetts
Directs the daily operation of a biologics QC department testing and reporting of release and stability samples for drug substance and drug product.
Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
Establishes and communicates performance objectives for QC staff that are consistent with the businesses unit goals, Quality and BDO objectives.
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent.
Directs the efficient and timely technology transfer of methods.
Directs the training and scheduling of scientists in cell and immunological biochemistry, separation sciences, spectroscopy and physical analyses to assure testing activities occur in an efficient and cGMP compliant manner.
Ensures that all QC personnel have adequate training, education and experience to perform their GMP related job function effectively.
Directs programs or procedures which assure the proper qualification/calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations.
Participates in compliance related teams working towards the goal of continuous improvement.
Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
Ensures all necessary testing is carried out.
Issues and prepares or approves laboratory investigations using electronic investigation management system (e.g. TrackWise), as needed.
Administers and maintains Laboratory Information Management System (LIMS), stability and retention programs.
Ensures that stability data supports the retest / expiry date and storage conditions of the product.
Ensures that stability studies performed at the site are performed according to approved protocols and procedures.
Ensures an effective process is in place for reserve sample collection and storage.
Completes Annual Product Quality Review Report elements as established in products/systems schedule.
Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Knowledge of science generally attained through studies resulting in a Master of Science degree in science, engineering, biochemistry, related discipline, or its equivalent is required
A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics Quality Control laboratory or a related biopharmaceutical industry.
In depth knowledge of analytical biochemistry quality control procedures, and the application and interpretation of GMP concepts and compendia requirements e.g. USP, CFR of daily laboratory operations.
Knowledge of laboratory equipment, instrumentation, and techniques including, but not limited to, HPLC, LCMS, spectroscopy, cell culture and immune assays.
Experience in building and growing an organization into a high performance team is highly desirable.
Experience leading and managing a large, multi-leveled organization is essential.
Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance is required.
Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise.
Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable
Associate Directors have business needs to interact with any employee at any level of the Devens facility with daily interactions with other Quality Unit staff, Supply Chain, IT/Automation, Technical Services and Manufacturing staff. Additional contact with general business functions includes human resources, EHS, Finance and interaction with BMS staff at other locations including corporate. In addition there is periodic contact with outside vendors as well as the occasional direct interaction with representatives from health authorities / regulatory agencies.
Work is largely performed in a modern office, laboratory and manufacturing facility where one must be aware of the presence of workplace hazards including pressurized liquids gases, steam and hazardous chemicals. Use of Personal Protective Equipment (PPE) will be required in some portions of the facility.
Establishes operational objectives and delegates assignments to subordinates. Objectives are reviewed by senior management to determine success of the operation. The incumbent is involved in developing, modifying, and executing company policies that affect immediate operations and may have company-wide effect. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budget, schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
Works with minimal supervision on the accomplishment of agreed upon goals and objectives. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled