What are the responsibilities and job description for the QC Microbiology Manager position at INCOG BioPharma Services?
We are seeking a Quality Control Microbiology Manager that has a passion for leading people, and has familiarity with transformational, situational, and servant leadership concepts. The Manager will support continuous personal and professional development of QC microbiology staff through meaningful goal setting, performance management, and career development plans.
The Quality Control Microbiology Manager will work closely with the Director of Quality Control and will develop the program for performing microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). The Manager will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build.
The Quality Control Microbiology Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Manager will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The manager will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the manager will possess a demonstrated ability to influence positive outcome without direct reporting authority.
Key Responsibilities:
The Quality Control Microbiology Manager will work closely with the Director of Quality Control and will develop the program for performing microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). The Manager will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build.
The Quality Control Microbiology Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Manager will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The manager will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the manager will possess a demonstrated ability to influence positive outcome without direct reporting authority.
Key Responsibilities:
- Recruit, build, and lead a team (initially 2-5 people in the first 12-24 months) to establish the new GMP QC Microbiology Laboratory
- Train, support, and maintain an engaged work force competent in the microbiological testing required to support a state-of-the-art aseptic drug product manufacturing facility.
- Lead through coaching, mentoring, and maintaining at-the-bench presence in the laboratory to ensure rigorous scientific and quality work standards.
- Lead development of a world-class QC platform by leveraging expertise to establish a robust environmental monitoring program and develop laboratory processes that adhere meticulously to procedures and regulatory requirements for the evaluation of microbiological aspects of drug products, excipients, and process materials. This includes, at a minimum, tests for sterility, endotoxin, and bioburden.
- Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
- Establish a laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory. Use a positive and proactive approach to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
- As the subject matter expert, maintain a state of constant inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
- Lead laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
- Utilize various paper and automated systems (Kneat, Veeva, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
- Use applied statistics to analyze and track test results to identify sources of variability and error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.
- Spearhead and leverage robust and current regulatory intelligence on the ever-evolving regulatory landscape, policies, and pharmaceutical industry trends through continuous education, networking, literature, trade organizations, etc.
- As the QC microbiology laboratory owner, partner with program owners to develop PM and calibration plans to coordinate upkeep, conformity and IQ/PQ/OQ of instruments and laboratory environment.
Minimum Requirements:
Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role tied to microbiology testing for aseptic drug products.
Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control. First-hand experience participating in and/or hosting audits/inspections related to Quality Control
Demonstrated experience with microbiology suitability development work and USP/EP microbiology requirements.
Experience with validating and qualifying laboratory instrumentation.
Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, minitab, etc.)
B.S. in Biochemistry, Biology, or Microbiology
Additional Preferences:
- Advanced Degree
- Design or use experience with LIMS (Laboratory Information Management Systems)
- Experience with Kaizen, Six Sigma, and/or Lean principles
- Experience in an isolator-based aseptic drug product manufacturing facility
- Project Management experience
- 2 years of experience as a people leader or supervisor