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Barden are delighted to be supporting our Global Biopharmaceutical client in their search for a Senior Microbiologist – Technical Services / Manufacturing Sciences for their state-of-the-art start up biotech manufacturing campus in Limerick.
ABOUT THE ROLE:
The Senior Microbiologist Technical Services / Manufacturing Sciences will be responsible for establishing and implementing the operational microbiological, viral and environmental monitoring programs at the Limerick manufacturing site. You will provide technical support for the facility startup 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.
Roles & Responsibilities:
- 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.
ABOUT THE PERSON:
Education & Work Experience:
- Hons Degree Qualified BSc, MSc, or PhD degree based in microbiology, biotechnology, biochemistry or similar discipline.
- 5+ Year working in large molecule GMP manufacturing environment, operating in frontline microbiological support.
- Demonstrated technical capability with high productivity.
- Proven track record of curiosity with learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
Candidates must be an EU Citizen or hold a valid work permit/visa to be considered.
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.
