JOB SUMMARY

The Senior Manager, QC Microbiology will lead, develop, and direct the QC Microbiology and Sterility Assurance programs at the site. This role will develop and maintain all documentation with regards to testing requirements and strategies and serve as a subject matter expert (SME) for microbiology and sterility assurance issues and provide technical expertise aligned with current GMPs and current industry practice. Responsible for EMPQ and Quarterly and Annual EM/Utility Monitoring reports.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Lead, manage and professionally develop all staff members.
• Oversee the execution of EMPQ, Cleaning Disinfection studies, and ensure a compliant site EM/Utility monitoring program.
• Manage, develop and maintain the Environmental Monitoring Program and prepare quarterly and annual trend reports and provide suggestions for continuous improvement.
• Accountable for, but not limited to, testing of raw materials (microbial testing), utilities/environmental monitoring and in-process/final product samples.
• Assures that the QC laboratory operations are appropriately staffed and trained to meet both internal and external compliance (cGMP) requirements.
• Accountable for managing the sterility assurance program to ensure quality, product specifications and adherence to all current GMPs, ICH and FDA guidance documents, Annex 1, local procedures and Emergent Global standards.
• Ensure the laboratory remains current with all changes to applicable compendia and ability to implement changes in a timely manner.
• Review and approve technical protocols and reports.
• Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigations and deviations.
• Manage relevant quality control activities and prioritize work to ensure site and project timelines are met.
• Interface with other departments and sites regarding special projects and quality issues.
• Coordinate and supervise collection of testing, trending, and data reported in the Quality Management Review and Annual Product Review.
• Liaise with Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

• Bachelor's degree in Microbiology, Biology, Chemistry or related scientific field. Advanced degree (e.g. Masters) is preferred.
• 8+ years relevant experience within the vaccine and biopharmaceutical industry with experience in aseptic processing required.
• 5+ years of supervisory experience or demonstrated leadership role.
• Demonstrated knowledge in Sterility Assurance program is required.
• Demonstrated knowledge of GMPs and FDA requirements is required.
• Quality Systems experience desirable.
• Must be able to critically evaluate data summaries and conclusions.
• Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
• Must possess cGMP knowledge across all QC functions.
• Must have a knowledge and experience with cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines.
• Must be a team player.
• Ability to influence without authority and influence within a highly matrixed organization.
• Excellent interpersonal skills both verbal and written

If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $171,500 to $207,500. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.