Associate Director - Microbiology and Aseptic Processes

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Bristol Myers Squibb
Associate Director - Microbiology and Aseptic Processes
in
Manati
Puerto Rico
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
This position is responsible for managing the Microbiology Laboratory and the Aseptic Processes Support. The incumbent will be responsible for managing the microbiological testing of Drug Substance, Raw Material, in process samples and combination products finished drug product testing. In addition, the incumbent will be overseeing the environmental monitoring program providing technical and scientific leadership to the BMS-Manatí site in the Microbiology field and as the Aseptic process and Sterile Manufacturing Center of Excellence. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. This position will interface with all Health Authorities and external liaisons in the review of scientific elements for Drug product approval.
MAJOR DUTIES AND RESPONSIBILITIES:
Develops and implements goals, objectives and mechanisms to ensure the optimum operational, financial and regulatory performance of the microbiological testing laboratory consistent with departmental and site strategies, SOPs and WWQ&C policies. Oversights microbiological testing of raw materials, finished products, USP water and cleaning samples. Supports validation activities of the site ensuring microbiological testing of validation samples is performed as required period. Coordinates administrative activities, ex. HR issues, budget, hiring, performance partnerships, etc. Provides technical leadership and guidance to the site QC Microbiology and Aseptic Processes staff to insure timely completion of goals and objectives. Prioritizes projects and determines resource constraints when necessary. Ensures that site Microbiology and Aseptic Processes staff receives training in appropriate procedures and protocols, including safety, cGMP training, etc. Overall, assures compliance with all accepted laboratory and safety procedures. Ensures that the Microbiology and Aseptic Processes personnel have the required materials, equipment and tools to support site operations. Serve as a key liaison with the Microbiology and Compliance Network. Participates on project teams to ensure that laboratories representation is provided on technical issues. Assures that data and reports generated by direct reports are consistent and accurate. Interfaces with other BMS groups in GPS on project issues to build collaboration and harmonization within the development and manufacturing network at BMS. Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, etc.). Maintains a safe work environment for Microbiological laboratories and Aseptic Processes personnel. Interacts and supports inspections and regulatory submissions with regards to Microbiology and Aseptic Processes matters. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives. Ensures that deviations from procedures and specifications are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence / recurrence of deviations and that no materials are released before the completion of the investigation. Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Assures that the Microbiology and Aseptic Processes equipment (if required) and personnel are formally qualified before release testing of products/materials is performed. Ensures the effectiveness of the environment review committee (ERC) for the review and adherence of conference of corrective and preventive actions associated to the sterile operations environment controls. Assures accuracy and completion of Annual Product Quality Review Report elements pertaining the laboratory inputs as established in products / systems schedule. Approves or reject procedures affecting drug products, raw material, and USP water or packaging components.
Knowledge/Skill:
BS in Microbiology, Biology or Equivalent scientific field
Ten (10) years of progressive managerial experience within the quality operations function of a pharmaceutical/health care industry and regulatory agencies, with experience in chemical analytical and/or microbiology laboratories.
Knowledge in microbiological instrumentation and techniques and aseptic processes.
Strong leadership skills
Proficient in cGMP's and FDA regulations and requirements.
Excellent interpersonal skills
Working knowledge in PC's and electronic tools.
Excellent communication skills in both English and Spanish
A systematic decision maker, assuring decisions are fact based and clearly documented
Planning skills
Excellent analytical and problem solving skills
Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management
Must be innovative and creative and utilize all available resources.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 with the resources to pursue their goals, both at work and in their personal lives. Company:****
R1521953_EN Updated:
2020-06-17 00:00:00.000 UTC Location:
Manati, PR
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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