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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 Manager, QC Microbiology, is a highly critical role and is responsible for managing the QC Microbiology Laboratory which provides support to the sterile pharmaceutical manufacturing site. This department is responsible microbiological related testing of in-process samples, final product sterility testing, critical utilities sampling and testing, Validation and requalification support, biological indicator qualification, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. The Manager QC Microbiology is responsible to act as the SME during regulatory inspections.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of sterile pharmaceutical products.
- Advanced data integrity knowledge and practices.
- Intermediate understanding of statistics, control charts, action and alert limits.
- Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
- Intermediate knowledge of Good Engineering Practices and Validation Principals:
URS, IQ, OQ, PQ, PVs, etc.
- Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
- Advanced verbal and written communication skills.
- Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
- Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
- Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
- Advanced 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.
- Advanced knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
- Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.
Duties and Responsibilities
Manage QC Microbiology department
- Management and coordination of the Microbiological Laboratory testing program and scheduling to ensure timely testing and results, to support final product testing and release, incoming components and materials testing and release, and monitoring of the critical utilities systems.
- Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory.
- The 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.
- Ensure that Microbiology lab test results which exceed the specification limits investigated, and effective CAPAs are implemented.
- Ensure the site and department objectives are met.
Manage and develop direct reports.
- Management and scheduling of Microbiology laboratory personnel within the department to meet the Manufacturing schedule and needs.
- Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
Drive continuous improvement efforts across the department including implementation of rapid technologies.
Perform other tasks as assigned.
Education and Experience
- Bachelor’s degree required, preferably in Microbiology or related science.
- Advanced degree preferred.
- 7 years’ relevant work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring in an aseptic sterile manufacturing facility.
- 2 years of leadership experience preferred.
- Must have experience in supporting sterile compounding and filling operations.
- Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.
- Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
- An equivalent combination of education of experience may substitute.
- The incumbent will be required to work in an office and Microbiology laboratory environment.
- The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as‑needed basis.
- The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
- Occasional travel may be required.
Definitions and Abbreviations
- USP – United States Pharmacopeia
- MHRA – Medicines and Healthcare Products Regulatory Agency (UK)
- EU – European Union
- JP – Japanese Pharmacopeia
- BP – British Pharmacopeia
- PMDA – Pharmaceuticals and Medical Device Agency (Japan)
- BET – Bacterial Endotoxin
- EM – Environmental Monitoring
- DEA – US Drug Enforcement Agency
- EPA – Environmental Protection Agency
- OSHA – Occupational Safety and Health Administration
- MSDS – Material Safety Data Sheets
- HAZCOM – Hazard Communication
- URS – User Requirement Specification
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- PV – Process Validation
- Process Simulation/Media Fill – A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.
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.
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.