Senior Associate Scientist

Catalyx is seeking a Senior Associate Scientist to join our team and work on our customer site in Cork on a 12-month fixed term contract.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

The Role :

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success.  As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

Responsibilities:

• Driving method development, validation and verification of Microbiological methods for the introduction of New Products/ New Methods.

• Writing and Management of Protocols and Reports.

• Provide Microbiological technical expertise to the QC team with respect to microbiological testing methodologies and techniques, equipment troubleshooting and compliance activities.

• Lead, support and coordinate the introduction of new QC test laboratory, including design and installation.

• Support the deployment of rapid micro techniques and emerging technologies that may be required in QC.

• Provide technical mentoring and feedback to the team.

• Provide technical support to manufacturing, Quality and QC during manufacturing and/or QC investigations.

• Manage and perform activities to support site projects such as disinfectant efficacy studies.  

• Review and approve documentation on behalf of QC.

• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives.

• Management and communication of QC metrics such as Site routine metrics, Safety and compliance expectations.

• Liaise and support Site Microbiologist when required.

• Ensure compliance to GxP, safety and environmental standards.

• Conduct and document out-of-specification/out-of-trend result investigations.

• Provide QC support for site plans, protocol executions, and summary reports.

• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.

• Lead and implement initiatives that add value to QC Operations.

Requirements:

•  Degree in Biology, Chemistry, or related field.

• Minimum of 5 years of relevant experience in a laboratory setting.

• Strong knowledge of molecular biology, cell biology, and biochemistry.

• Experience with a variety of laboratory techniques, including but not limited to: PCR, Western blotting, cell culture, and microscopy.

• Excellent communication and interpersonal skills.

• Ability to work independently and collaboratively with a team.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.