Senior Supervisor, Quality Control Microbiology
Warren County, New Jersey
Expiry Date :
Fri, 18 Dec 2020 23:59:59 GMT
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At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through 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. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMSs continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. Purpose and Scope of Position The Senior Supervisor, QC Microbiology is responsible for routine and non-routine microboiologcal testing, environmental monitoring in support of cell therapy product manufacturing. The Senior Supervisor, QC Microbiology is also responsible for peer review, training, supporting document management, projects, CAPAs and investigations in accordance with the organizations policies, procedures and state, federal and local laws and compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times. Required Competencies: Knowledge, Skills, and Abilities – Advanced hands on experience with various microbiological testing techniques, environmental monitoring techniques and scientific knowledge. – Advanced knowledge of how to conduct effective training and coaching of analysts – Influence routine testing strategies and sampling requirements in support of regulatory submissions – Act as a technical lead on microbiology test validations and method qualifications. – Develop environmental monitoring programs for cell therapy product candidates. – Manage the day to day activities of the environmental monitoring team. – Follow directions well; work cooperatively as a team leader, an individual contributor and as a team member. – Responsible for maintaining the laboratory test schedule for all microbiology activities and delivery of results within established batch release timelines. – Perform duties of a Qualified trainer and assist department Management with employee training, qualification and professional development. – Prepare Microbiology employee task assignment schedules and allocation of resources to execute department required activities in support of operations. – Advanced management and organizational skills. – Advanced team and individual leadership skills. – Advanced understanding of relevant scientific and technical principles. – Basic project management skills; capable of participating in departmental teams. – Advanced knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring. – Advanced written and verbal communication skills. – Ability to develop detailed instructions accurately. – Ability to gown and maintain a sterile work environment. – Ability to work under limited supervision. – Ability to mentor peers on day-to-day tasks and more technical tasks; cooperative and works well with a team. – Communicates effectively with peers, management and cross-functionally across the site. – Intermediate knowledge of laboratory and aseptic processes. – Advanced critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments. – Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections Duties and Responsibilities – Performs routine laboratory and EM activities. – Prepares schedules and sample labels. – Read EM and testing plates and assess against alert and action levels as appropriate. – Performs microbial isolation techniques, Gram stains and supports microbial identification process. – Performs environmental monitoring activities in support of manufacturing. – Maintain qualification status on aseptic gowning, sterility testing, etc. – Demonstrates aseptic technique when performing a Microbiological Test or EM. – Perform testing/monitoring activities associated with protocols or special projects as required. – Review all data in accordance with applicable procedures and cGMP requirements. – Apply technical knowledge and abilities to ensure all testing is performed in a compliant matter. – Complete all review in accordance with required timelines. – Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. – Train new analysts to general job duties and specific testing and monitoring activities. – Complete necessary training to become a qualified trainer. – Document training per procedural and cGMP requirements. – Determine training schedule and develop training content. – Participate in hiring and onboarding processes of new analysts. – Coach other analysts in troubleshooting microbiology methods, EM techniques and scientific equipment. – Assists with developing best practices in the laboratory – Coordinates testing and monitoring activities within the QC lab and manufacturing facility. – Ensure proper tracking of non-routine testing events. – Follow up on testing execution with analysts, ensure communication to Laboratory Management. – Responsible for tracking tools (EM batch release, sample trackers, etc.) – Supports lab management in mid to long range capacity planning. – Assist with allocation of resources, such as instrumentation and analyst availability. – Communicate effectively with management regarding more complex issues. – Perform assigned tasks within a CAPA, deviation or project. – Participate in more complex projects and continuous improvement efforts. – Draft and review technical documents, such as SOPs and protocols. – Communicate effectively with management regarding task completion, roadblocks and needs. – Assist in the development and implementation of corrective actions. – Prepares written QC Microbiology trend reports. – Determines impact of changes to QC department and supported GxP computerized systems. Responsible for assisting in Development Operations QC sample management programs. – Collaborates with the QC Sample Management team and ensures GMP compliance of the laboratory area and operations under her/his responsibility. – Ensures the chain of custody of QC samples is maintained throughout the complete life span of samples including raw materials, bulk drug substances, packaging materials and stability samples Drive and Manage projects within the group – Using technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department. – Participate on tech transfer QC teams for assay qualification of molecular and cell- based assays for cell therapy programs. Design and generate assay qualification protocols and reports. – Accepts responsibility for group projects; designs and executes experiments, analyzes results, and writes technical summary reports. – Capable of handling complex issues and solving problems with minimal guidance. – Prepare and present continuous improvement projects to management. – Utilize advanced scientific principles to assist in analytical testing methods and the proper use of laboratory equipment. Carry out management authority for review and approval activities – Serve as author or technical reviewer of appropriate departmental procedures. – Review documentation as required by laboratory procedures. – Perform approvals for relevant laboratory activities. Provide Guidance and Leadership – Assist senior management with the development, implementation, and deployment of training. – Coach analyst on troubleshooting analytical methods and scientific equipment. – Teach junior scientists on theory and application of analytical methods. – Lead and develops best practices. Education and Experience – Bachelors Degree, particularly in Microbiology or Science related field, required. – 10 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement. – An equivalent combination of education / experience may substitute. Working Conditions – The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment. – The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc. – The incumbent will have to perform work in a controlled environment with strict glove and gown requirements. – The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product. – This position requires regular medical surveillance and may require incumbent to wear a respirator or gown. – The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required. – The incumbent may analyze data and work with spreadsheets and graphs on a daily basis. – The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day. – The incumbent must be able to lift/carry NMT 25 lbs. If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMSCART This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. 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.