Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Purpose and Scope of Position:
The Sr. Manager - Environmental Monitoring, is a highly critical role and is responsible for managing the QC Microbiology Environmental Monitoring department. This department is responsible for the monitoring of the sterile manufacturing environment in the controlled areas to ensure that sterility assurance standards are met with regards to viable microorganisms and non-viable particulates. The environments monitored must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. This is a three shift operation (covering 5 to 6 days per week), which has a dedicated Environmental Monitoring team that supports and monitors the sterile manufacturing operations and environments to ensure that it remains in compliance. The Sr. Manager QC Environmental Monitoring is also responsible for the Aseptic Gowning training and Qualification program, Aseptic Technique training, trending of environmental and gowning data, and Environmental Monitoring deviations and associated CAPAS. The EM Monitoring department is a vital component of the Process Simulation/Media Fill process, assuming the role of the Quality Control oversight, as well as the inspection of the media fill vials and final records. The Sr. Manager QC Environmental Monitoring is responsible to act as the SME during regulatory inspections.
Duties and Responsibilities:
The Sr. Manager – QC Environmental Monitoring is responsible for managing the Environmental Monitoring department located at the Celgene Abraxane manufacturing facility. This department is responsible for monitoring and ensuring that the environmental conditions where the product is manufactured meets cGMP and regulatory requirements with respect to viable microorganisms and non-viable particulates. EM Monitoring support for the manufacturing operations is scheduled for 24 hours per day, and 5 to 6 days per week.
The Sr. Manager-QC Environmental Monitoring is responsible for:
• Management and scheduling of EM Monitoring personnel within the department to meet Manufacturing schedule and needs
• Management and optimization of the Aseptic gowning training and qualification program
• Development and management of the Aseptic Technique training program.
• Monitoring and trending of Aseptic personnel time spent in the Sterile Manufacturing area.
• Development and management of SOPs and forms required to support the Environmental Monitoring of the controlled areas where aseptic manufacturing is conducted.
• The Sr. Manager EM Monitoring is responsible for ensuring the all environmental monitoring results are read or reviewed by trained personnel, and recorded using Good Documentation Practices.
• Environmental isolates, if recovered for the Aseptic area or during gowning monitoring are isolated and then an identification determined using an outside lab. A history of all isolates identified is maintained as compliance records.
• The Environmental Monitoring Manager is responsible for ensuring that all non-viable and viable data is captured in spreadsheets and trended.
• Monthly and quarterly Environmental Mentioning reports are issued to support QA and regulatory requirements.
• The Sr. Manager, QC Microbiology plays a critical role in ensuring that all materials, products, methods and equipment are within specifications and ensuring accurate and timely disposition of test results and compliance investigations. The incumbent is the Subject Matter Expert for the EM program.
• The Sr. Manager- EM Monitoring is responsible in ensuring that environmental or gowning monitoring excursions which exceed the specification limits, are submitted as a Deviations in the eQRMS system, investigated, and effective CAPAs are implemented.
• The Sr. Manager Environmental Monitoring acts as a vital component of the Media Fill/Aseptic Process Simulation process, approving the protocols, providing QC monitoring during the media fills, and is responsible for the incubation and inspection of media filled vials, compiling the results to be reported in the Media Fill documentation
• The Sr. Manager QC Environmental Monitoring is responsible to act as the SME during regulatory inspections.
• This position is responsible for the management of the Environmental Monitoring department whose purpose is to ensure that the sterile manufacturing area is suitable, meeting or exceeding FDA, MHRA, PMDA, etc. regulations and guidelines. This is a management position supporting manufacturing (24 hours per day/ 5+ days/week) and laboratory operations.
• The incumbent will be required to work in an office environment.
• Additionally, the incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, on an as-needed basis.
• Will be required to occasionally work in the vicinity of high speed filling equipment, conveyors, autoclaves, depyrogenation tunnels, washers, lyophilizers, vial cappers, etc. located in Grade A and B areas.
• The incumbent will additionally be required to work in the Microbiology laboratory: having a good understanding of microbiology lab equipment and processes.
• The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving Environmental Monitoring excursions or questions during shift operations.
• Occasional travel may be required.
• Strong knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of sterile pharmaceutical products.
• Strong data integrity knowledge and practices.
• Strong understanding and demonstrated use of statistics, control charts, action and alerts related to environmental monitoring,
• Must have experience in supporting sterile compounding and filling operations.
• Demonstrated knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
• Demonstrated expertise in Media Fills or Process Simulations.
• Strong knowledge of Good Engineering Practices and Validation Principals: URS, IQ, OQ, PQ, PVs, etc.
• Experience in participating and supporting regulatory audits: FDA, MHRA, PMDA, etc.
• Ability to manage and practice continuous optimization of the site EM Monitoring, Aseptic Technique training, and Gown qualification programs. .
• Strong experience in working with Quality Systems: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• Requires excellent verbal and written communication skills. Ability to collaborate with outside department to drive operational and quality excellence.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
• Lead the department to ensure that site and department objectives are met.
• Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
• Demonstrated mentoring and coaching, influencing, negotiating and personal interaction skills.
• Demonstrated resource management and planning skills. Must be flexible and adaptable, and able to work under pressure, while meeting designated time lines.
• Demonstrated ability to develop, manage, and forecast budgets.
• Knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
• Proficiency with the use of Microsoft Word, Outlook, Excel, PowerPoint, etc.
Education and Experience:
• Requires a Bachelor's degree in Microbiology or related science from an accredited college or university. An advanced degree, training or qualifications is a plus.
• A minimum of 9 years' experience working in the Environmental Monitoring area and/or Microbiology laboratory in an aseptic sterile manufacturing facility is required. Strong Environmental Monitoring management experience in a sterile manufacturing site is required.
• 3+ years of progressive management experience.
• Strong knowledge of FDA, MHRA, PMDA, etc. aseptic manufacturing regulations and guidelines.
• Minimum of 9 years working in an aseptic manufacturing environment.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.