Senior_Principal Microbiologist (Site Lead)

A Senior or Principal or Senior Principal Microbiologist is required by CareerWise Recruitment for our client based in Limerick. The Senior/Principal/Senior Principal Microbiologist will be supporting the Technical Services/Manufacturing Sciences groups. The TS/MS Microbiologist will be responsible for establishing and implementing the operational Microbiological, Viral and Environmental monitoring programs at the Limerick manufacturing site. As the Microbiology Lead for the facility the successful candidate will provide technical support for the facility start-up defining Microbial and Viral control strategies in partnership with engineering, operations, quality control and quality assurance. The role will provide support to up and downstream processing areas and will own activities such as EMPQ and preparation of strategy documentation including contamination FMEA and response plans and the product protection control strategy. The successful applicant will have a deep technical expertise in their areas of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process efficiency by implementing new technologies and process improvements. They will maximize the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.

Role of this position

• Have an in-depth knowledge of the science of biotech manufacturing microbiological controls and associated analytical tests. Understand molecule-specific control strategy and basis of specifications and critical quality attributes.
• Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose microbial control strategy is developed and transferred
• Knowledge of virology controls required for mammalian cell culture, virus and mycoplasma analytical methodologies
• Establish and own the EMPQ program, contamination FMEA and contamination response plan
• Creates, revises, or reviews documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs investigations as needed
• Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and monitoring needs are captured in manufacturing electronic documentation
• Work as part of cross-functional teams, and establish partnerships with applicable functions, operations and TSMS Lab to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.
• Understand basic statistical methodologies engage with Statisticians to assign specifications, validation acceptance criteria, material sampling criteria and analysis of batch data for summary reports and product reviews.
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Understand and ensure compliance with safety, compliance, and regulatory expectations
• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies

JOB REQUIREMENTS

• Hons Degree Qualified BSc, MSc, or PhD degree based in microbiology, biotechnology, biochemistry or similar discipline.
• Experience (>5 yrs.) working in large molecule GMP Manufacturing environment, operating in frontline Microbiological support

WORK ENVIRONMENT:

• These are 8-hour day roles. As a manufacturing support function, the need for occasional evening or weekend support can arise.

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.