Manager, QC - Microbiology

Bora Pharmaceuticals; Rockville (MD); On-site; USD 108,000 - 150,000; Full time

Job summary

Bora Biologics in Rockville is seeking a Manager of Quality Control - Microbiology to lead a QC team and oversee environmental monitoring and microbiology testing in a cGMP environment.

You will develop, transfer and validate microbial test methods, support contamination control, and prepare for audits and inspections. Strong data integrity and leadership are essential.

Qualifications

• Bachelor's degree in a scientific discipline; 5+ years QC Microbiology cleanroom experience.
• At least 2 years of prior experience supervising staff focused on performance and productivity.
• Significant knowledge of Quality Control processes in a GMP testing environment; microbial method validation.
• Familiarity with EU GMP Annex 1 and data integrity (ALCOA+) requirements.
• Experience with microbial identification and environmental excursion investigations.
• Ability to independently determine schedules, methods and evaluation criteria.

Responsibilities

• Lead and supervise QC Microbiology team to prioritize lab scheduling, testing, and review.
• Oversee environmental monitoring of cleanrooms and GMP facilities per ISO and EU Annex 1.
• Contribute to Contamination Control Strategy and risk assessments for facility and processes.
• Read, trend, and report testing results; recommend changes to senior management.
• Maintain GMP systems and respond to deficiencies; ensure data integrity across records (ALCOA+).
• Support investigations, CAPA, deviations, and risk management; lead root cause analysis.

Skills

Team leadership

GMP knowledge

Microbiology testing

Environmental monitoring

Method validation

Data integrity ALCOA+

Root cause analysis

Communication skills

Education

Bachelor's Degree in a scientific discipline

Tools

SAP

LIMS

Veeva

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

The Manager of Quality Control - Microbiology is responsible for managing a team of QC professionals and overseeing the daily operations of the environmental monitoring and utility monitoring programs and microbiology testing at Bora Biologics Rockville site to ensure compliance with cGMP standards and the current EU GMP Annex 1 expectations for contamination control. This person will interact extensively with other department supervisors, Quality personnel, Manufacturing personnel, other business partners, and external clients and sponsors. This person will also be responsible for the development, transfer and validation of microbial test methods. The Manager supports the microbiological elements of the site Contamination Control Strategy and ensures the integrity (ALCOA+) of all microbiological data across manual and electronic records. This role also supports client- and sponsor-facing quality activities, and readiness for client audits and regulatory inspections.

Essential Functions:

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

• Manages the team to ensure that priorities for lab scheduling, logistics and flow of activities for testing and review are established and followed and that workload is also prioritized and staffing is optimized to ensure timely and effective performance.
• Supervise and monitor the team to ensure that the environmental monitoring of the clean rooms and GMP facilities are performed under ISO and EU specifications and the current EU GMP Annex 1. Address any deficiencies appropriately.
• Contribute to and maintain the microbiological elements of the site Contamination Control Strategy in alignment with the current EU GMP Annex 1, including supporting facility, utility, personnel, equipment, and process contamination risk assessments.
• Read, trend and report testing results to assess compliance and control of facility, utilities, and manufacturing process and recommend any needed changes to senior management.
• Monitor the GMP systems currently in place to ensure compliance with documented policies and regulatory guidance documents and respond to deficiencies appropriately.
• Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures. Lead/support laboratory investigations and facilitate root cause analysis.
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes. Gather metric information for use in continuous improvement of Microbiology area.
• Develop, revise and review SOPs, qualification/validation protocols and reports, and help execute validation studies to support the validation and qualification of manufacturing area.
• Ensure proper oversight and guidance for direct reports in the areas of protocol development, report writing, trend report and deviation management.
• Review proposed changes to EM and utility systems, procedures, methods, as appropriate.
• Participate in and prepare for internal /external audits where necessary.
• Train and mentor staff on technical concepts and methods. Develop and implement mechanism for assessing knowledge and understanding.
• Collaborate with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Clients whenever necessary.
• Ensure data integrity (ALCOA+) across all QC Microbiology records, including LIMS entries, , and manual records.
• Support client- and sponsor-facing quality activities, including responding to client questions on environmental monitoring trends and excursion investigations, and participating in client audits.
• Support the transfer, qualification, and validation of microbial test methods for incoming client products and manage the environmental and utility monitoring programs across a multi-product, multi-campaign CDMO environment.
• Own QC Microbiology performance metrics (e.g., turnaround time, right-first-time, on-time testing) to support batch release schedules and client commitments, and drive continuous improvement.
• Where applicable to site operations, ensure appropriate aseptic practice, personnel and gowning qualification, and viable personnel monitoring programs.
• Perform other duties as assigned.

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:

Minimum Requirements

• Bachelor's Degree in a scientific discipline and minimum of 5 years of QC Microbiology cleanroom experience.
• At least 2 years of prior experience supervising staff focused on managing performance and productivity.
• Significant knowledge of, and experience with Quality Control processes, working in a GMP testing environment, and Microbiological method validation including drafting method validation protocols and reports
• Familiarity with current EU GMP Annex 1 and contamination control strategy expectations and data integrity (ALCOA+) requirements
• Experience conducting laboratory and environmental excursion investigations
• Experience with microbial identification
• Ability to act independently to determine schedules, methods and procedures on new assignments
• Possesses the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
• Able to handle multiple priorities in a fast-paced environment
• Excellent written and verbal communication skills

Preferred Requirements

• Prior experience providing oversight of a cleanroom microbial area of expertise, such as environmental monitoring or utilities monitoring group.
• Experience working on complex problems in which analysis of situation or data requires an in depth evaluation of intangible variables.
• Experience performing risk assessments
• Experience in a CDMO or multi-client/multi-product cGMP environment
• Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
• Proficient in the use of standard business software and GMP data systems, including SAP, LIMS, Veeva, and statistical trending tools.

Salary Range:

$108,000-$150,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.