Process Microbiologist

Job Description:

Janssen Biologics is currently recruiting a Process Microbiologist within our Quality Assurance department to strengthen our team. The Process Microbiologist, Sassenheim is responsible for providing input for microbiological and contamination control of lentiviral product production for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Function description:

The Process Microbiologist has a robust background in microbiological control of biopharmaceutical manufacturing, particularly as it pertains to the manufacturing process and quality assurance with an extensive experience in Good Manufacturing Practices to ensure adherence to applicable regulations. The Process Microbiologist supports the development and/or improvement of the contamination control strategies, contamination prevention, and microbiological hygiene programs. They act as the primary microbiological SME and collaborate with relevant departments to provide input for process/facility contamination control, performance of microbial qualifications, microbiological monitoring, investigation of microbiological contamination issues and provide microbiological training in the facility. Process Microbiologist gives practical advice to production operators, quality and operations departments, and management on topics concerning contamination risk prevention.

Essential Job Duties and Responsibilities:

• Ensure contamination control strategy is consistent with cGMP and applicable regulations (e.g. EUDRALEX Annex 1 for aseptic manufacturing, Annex 2 for biological product manufacturing, Part 4 Advanced Therapy Medicinal Products, and Janssen requirements)
• Review changes related to design/improvement/maintenance of facilities, gowning, cleaning & disinfection, production processes, production equipment, sampling and testing related to microbiological control, aseptic handling, restriction of movement etc.
• Play a lead and proactive role in development and delivery of microbiology related training programs including aseptic operator training
• Play a lead and proactive role in design, qualification/validation, and maintenance of critical aseptic technique related process and studies
• Identify contamination risks and drives improvements related to the reduction of contamination risks on the shop floor with close cooperation with operators and management of the Manufacturing, and Maintenance departments
• Actively supports technical investigations of products, processes, etc. where microbiological input is required, and is part of contamination task forces
• Oversight of environmental monitoring program including design and maintenance of process environmental monitoring, review of routine/process environmental monitoring, water system and utility data for trends and support identification of appropriate corrective/preventive actions as required
• Maintain current knowledge of regulations and industry trends in contamination control
• Work closely with other key stakeholders including the QC Microbiology and QC personnel, Quality Assurance, Compliance groups and Operations

Additional duties

• Work closely with other key stakeholders including the QC Microbiology and QC personnel, Quality Assurance, Compliance groups and Operations
• Network and communicate with other Process Microbiologists at JSC sites within the organization
• May support in internal/external audits

Minimum Qualification

• BSc. or MSc degree in science, preferably in Microbiology
• At least 6 years of work experience in biopharmaceutical production/quality and are familiar with the operational processes.
• Experience in and or knowledge of biological pharmaceutical production related microbial contamination control
• High quality awareness and experience affinity with EUDRALEX volume 4 Annex 2 and low bioburden biopharmaceutical production process
• Excellent communication skills, written and verbal in English

Preferred skills

• Experience in and or knowledge of aseptic processing (Fill / Finish), viral production, biosafety level 2 containment facilities and isolators
• Experience affinity with EUDRALEX volume 4 Annex 1, part 4, and cGMP standards
• Excellent communication skills, written and verbal in Dutch

We also would like to see the following Key Competencies

• You are enthusiastic, independent, innovative (be able to think outside the box) and stress resistant (be able to deal with pressure, fast changes)
• You are able to motivate and coach people and act as trainer on your expertise
• You have the ability to balance risks and make difficult decisions
• You take ownership of your work and have the ability to plan and structure this

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

Hybrid Work