Senior/ Principal QC Microbiologist

Responsibilities:

The primary role of the Senior/ Principal QC Microbiologist is to provide technical expertise to support early phase cGMP manufacturing, and establishment and implementation of Environmental Monitoring and Aseptic Compliance programs for NJ Bio. Major responsibilities will include establishment of site policies and procedures related to aseptic/sterile processes, including design and execution of the contamination control strategy, airflow visualization support and review, aseptic behavior program, and training. The role will have technical oversight and approval authority of work performed by environmental monitoring contractors and outsourced testing labs. The role is responsible for understanding and applying emerging regulatory expectations, providing subject matter expertise during internal or external audits and drafting audit responses, and aseptic practice guidance and coaching.  The incumbent works cross-functionally with internal departments and external resources on QC related issues. The Senior/ Principal QC Microbiologist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Serve as subject matter expert (SME) for all aspects of microbiological testing, aseptic technique, contamination control, cleaning, disinfection, sanitization, and Environmental Monitoring Process Qualification (EMPQ).
• The candidate will be responsible for the development, oversight, and management of the Contamination Control Strategy (CCS) program which includes but not limited to:
  • leading site-wide contamination control and microbial assurance programs to maintain low bioburden manufacturing standards.
  • overseeing or performing environmental monitoring, reviewing micro testing data from contract laboratories and performing microbial analytics to ensure compliance with microbial quality requirements.
  • lead investigations into microbial contamination events, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
  • establish contamination control metrics and key performance indicators (KPIs), when appropriate, to track and report progress against site goals.
• Perform detailed review of environmental monitoring, endotoxin, bioburden, and sterility data to ensure correctness, accuracy, data integrity, and compliance.
• Analyze and trend environmental monitoring data and report to the Management Review Team (MRT), identify root causes of trends, and propose process improvements.
• Represent QC in interactions with internal and external partners, stakeholders, vendors, and clients.
• Train manufacturing operators in gowning and aseptic technique.
• Prepare and review SOPs, protocols, reports, certificates, etc. as needed.
• Assist senior management with audits, inspections, OOS, risk assessment, and root cause investigations.
• Write deviations, change controls, and CAPAs, and/or assist senior management with these documents.
• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Provide surveillance for emerging regulatory requirements and ensure manufacturing areas remain in compliance with site procedures and global regulatory agency requirements
• Hands-on sampling and testing of materials and environments as needed.
• Perform other tasks and assignments as needed and specified by management.

Requirements:

Required Knowledge, Skills and Abilities:

• Hands-on experience with various microbiological techniques in cGMP manufacturing operations, including non-viable and viable particulate air monitoring, bioburden, endotoxin, and sterility.
• Experience taking environmental monitoring samples.
• Experience with contamination control strategies, airflow pattern testing, and EMPQ
• Extensive knowledge and experience in cGMP, data integrity, FDA, EMA, ICH, USP, and Ph.Eur. guidelines.
• Comprehensive knowledge of clean room classification and regulatory requirements
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirements:

• BS, MS, or PhD degree in microbiology, biology, biochemistry, or related discipline.
• Experience in a GMP manufacturing or CRO setting.
• BS with at least 6 years of relevant experience, MS or higher degree with at least 4 years of relevant experience, or equivalent combination of work experience, education, and training.

Physical Demands:

• Ability to lift heavy objects (≤20 lb.) and perform other labor-intensive tasks as required.
• 50% Sitting and 50% Standing and Walking.
• Requires manual dexterity and visual abilities.

Working Conditions:

Office/ laboratory position

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.