MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
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 MacroGenics to ensure compliance with cGMP standards. This person will interact extensively with other department supervisors, Quality personnel, Manufacturing personnel, and other business partners. This person will also be responsible for the development, transfer and validation of microbial test methods.
Responsibilities and Job Duties:
- 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 maximized 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. Address any deficiencies appropriately.
- 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, and submissions to regulatory agencies, 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 Regulatory Affairs whenever necessary
- Perform other duties as assigned.
Education, Experience, & Credentials:
- Bachelor’s Degree in a scientific discipline and minimum of 6 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
- Prior experience providing oversight of a cleanroom microbial area of expertise, such as environmental monitoring or utilities monitoring group.
- Experience working on extremely complex problems in which analysis of situation or data requires an in?depth evaluation of intangible variables.
- Experience performing risk assessments
- Experience conducting laboratory and environmental excursion investigations
- Experience with microbial identification
Knowledge, Skills and Abilities:
- 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
- Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
- Broad knowledge base of cGMP requirements for quality control testing
- Flexibility and adaptability to facilitate the movement into different areas of QC
- Proficient in the use of Microsoft or equivalent software; word processing, email, spreadsheet or other analysis tools, database, and Internet
- Excellent written and verbal communication skills.
- This position may have supervisors, individual contributors, and QC analysts reporting to them.