Bongene Search is a fast growing US leading biotech recruiting firm.
We partner with the world’s leading biotech and pharmaceutical companies, as well as emerging players in the biopharma industry, to fulfil their most critical staffing needs. Bongene Search has proven record of success in placing highly qualified candidates in roles that perfectly complement their career goals and expectations.
Bongene Search represents the below opening from our client. This client is one of the world’s top healthcare companies.
Title: Microbiology Regional Manager
Location: Columbus, Ohio ( Relocation Assistance Available )
Position Summary
The role will serve as the Regional Subject Matter Expert (SME) for all microbiology-related issues affecting assigned nutrition plants. The manager will coordinate activities between the affected plant(s) and larger R&D QA or Quality organizations to provide rapid resolution of emerging and outstanding microbiological quality issues.
Responsibilities:
- Assist and support factory microbiology quality engineering and other personnel in conducting:
- Hazard analyses (HACCP) and risk assessments related to microbiological hazards.
- Microbiological root-cause investigations.
- Conduct and ensure plant level review and interpretation of microbiological data and relevant KPIs to drive improvements.
- Act as the SME for the consistent and practical application of Environmental Monitoring Programs (EMP), hygiene protocols, cleaning and sanitation practices, microbiological analyses, and standards.
- Work with functional group peers to define and/or assess ingredient, product, process, and package attributes relative to microbiological quality control.
- Ensure processes used in development can be duplicated in commercial operations while maintaining microbiological quality and safety.
- Anticipate conflict in project attributes and operations capability, and drive resolution.
- Design, manage, and interpret results of research projects that support microbiological safety and quality of new and existing nutritional products and production processes.
Core Responsibilities:
- Monitor ingredient, product, process, and package quality performance to identify microbiological quality issues and trends.
- Develop and implement corrective actions to support microbiological quality/safety.
- Collaborate closely with R&D, Sterilization Technology, and Quality Systems on diverse and challenging problems requiring innovative solutions.
- Possess knowledge in food microbiology, hazard analysis, quality risk assessment, statistical process control, and other advanced data analysis/problem solving techniques.
- Serve as a technical expert in designated product categories within the assigned region, collating and communicating information related to microbiology.
- Provide guidance and support in establishing microbiological quality criteria, and evaluating new manufacturing facilities, third-party manufacturers, and suppliers.
- Analyze data, scientific literature, and experimental results to translate into actionable recommendations with identified risks.
- Contribute to the oversight and/or preparation of quality documentation to support policies, procedures, methodologies, formulation changes, and specifications.
Supervisory/Management Responsibilities:
- Lead a team or teams, providing direction to accomplish objectives within a given timeframe and with limited resources.
- Manage non-exempt employees or direct the activities of other exempt employees on a project basis.
- Interact frequently with all levels across the division and production facilities, functional peer project managers, and other division management.
- Monitor quality performance criteria, identify trends, recommend corrective actions, and, where appropriate, independently implement corrective actions.
- Act as a resource and coach to members of site microbiology laboratories.
- Effectively deal with people of varying functions and levels of expertise.
Position Accountability/Scope:
- Apply experience to effectively anticipate and prioritize potential quality issues, even in novel situations, with minimal supervision.
- Assess risk of significant issues and develop action plans to minimize risk.
- Understand broad implications of decisions across functions and the impact of quality-related design criteria on product and operational costs.
- Use communication skills to influence decisions and other functional groups.
- Identify and articulate costs, risks, and benefits of alternative solutions.
- Track and report project costs and expenses.
- Make independent decisions with moderate risk profiles due to a broad base of knowledge and judgment.
- Solve complex technical issues and ensure proactive resolution in conjunction with management.
- Manage multiple assignments and/or tasks concurrently while meeting appropriate deadlines.
- Able to travel up to 40% (varies).
Education and Experience:
- Required: Bachelor’s Degree in Microbiology or a closely related area (e.g., Biology, Food Science). Advanced degree preferred or an equivalent combination of education and work experience.
- Preferred: Previous experience managing projects and/or work groups.
- Attention to detail and accuracy are important for effective performance.
- Broad understanding of Food Safety Microbiology.
- 10-12 years of experience in the food, pharmaceutical, health care, or related industry preferred.
Miscellaneous:
- This is an onsite role located in Columbus, OH. This is not a remote role.
