Global Biologics Stability AD

Bristol-Myers Squibb Devens, MA

About the Job

Description:

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.


One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.  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.


At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.


Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.


We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless.  It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.


The Bristol-Myers Squibb Devens site is a state-of-the-art biologics manufacturing facility located on 89 acres, just 45 minutes west of Boston. It is here that we will be fulfilling our critical mission to help patients prevail over serious diseases.


This 400,000 square foot complex represents the single largest capital investment in the nearly 125 year history of BMS, $750 million, and is a key part of our strategic BioPharma transformation.

Reporting to the Director, Network QC and Global Biologics Stability, the Associate Director of Biologics Stability is responsible for the daily activities of a Biologics Stability department and related third party operations.


The Associate Director of Biologics Stability will direct and oversees the Stability Assessment, Study Generation, Sample Management, Stability Data Evaluation and Trending and Stability Data Reporting generation and activities in accordance with cGMP and Company SOPs.

 

Key Responsibilities\:

  • Directs the daily operation of Biologics Stability department and not limited to Stability Assessment, Study Generation, Sample Management, Stability Data Evaluation and Trending and Stability Data Reporting generation and activities.
  • Acts as scientific lead and “voice of stability” in the meetings.
  • 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 Biologics Stability 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 execution of all commercial Biologics Stability studies. 
  • Directs the scheduling of all Biologics Stability studies to assure program activities occur in an efficient and cGMP compliant manner.
  • Ensures that all Biologics Stability 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 stability chambers, 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 activities are carried out.
  • Issues and prepares or approves stability related investigations using electronic investigation management system (e.g. TrackWise), as needed.
  • Administers and maintains Laboratory Information Management System (LIMS).
  • Ensures that stability data supports the retest / expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies.
  • Ensures that stability studies performed at the site are performed according to approved protocols and procedures.
  • Ensures that systems are in place for the development, approval and maintenance of stability protocols.
  • Ensures an effective process is in place for stability sample collection and storage.
  • Ensures that a system is in place for environmental controls and monitoring of stability chambers.
  • Completes Annual Product Quality Review Report elements as established in products/systems schedule.
  • Ensures adherence and compliance of aseptic processing practices, guidelines and overall aseptic processing simulation program where applicable.
  • Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other sites procedures and/or specifications. 

Qualification:

  • Knowledge of science generally attained through studies resulting in a Ph.D. or Master degree in science, engineering, biochemistry, related discipline, or its equivalent is required
  • A minimum of 10 years of experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics operation or a related biopharmaceutical industry.
  • In depth knowledge of biologics stability requirements, analytical biochemistry and the application and interpretation of GMP concepts and guidance requirements e.g. ICH, USP, CFR of daily GMP, statistical model and trends analysis is required to ensure compliant operation is in place for Biologics Stability program.
  • Knowledge of laboratory equipment, instrumentation, and techniques including, but not limited to, HPLC, LCMS, spectroscopy, cell culture, immune assays, EM equipment, Microbiological ID systems, Endotoxin testing, and membrane filtration testing is desired.
  • Experience in building and growing an organization into a high performance team is highly desirable.
  • Experience leading and managing matrix organization is desired.
  • 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 is essential.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of applicable business systems including\: SAP, LIMS, Maximo, SmartLab and Trackwise.
  • 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.

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference.