Micro/Cell Biologist

Overview

Porex is on a mission to make the world safer, healthier and more productive. Porex is looking for a Micro/Cell Biologist based in Beverly, Massachusetts. The successful candidate will be responsible for developing, implementing, and validating microbial retention filter testing protocols in compliance with ASTM and GMP guidelines. This role is critical to ensuring the safety and efficacy of our products by validating their microbial control.

Responsibilities

We are seeking a highly skilled and motivated Scientist to join our GMP testing team.

About the Role:

• Lead Upstream GMP test method development, validation, and documentation.

• The successful candidate will be responsible for supporting the development, implementing, and validating microbial retention filter testing protocols in compliance with ASTM and GMP guidelines. This role is critical to ensuring the safety and efficacy of our products by validating their microbial control.

• Design and conduct studies to validate the GMP microbial retention tests and author SOPs and validation documents.

• Develop and optimize testing methodologies in accordance with GMP guidelines to ensure accurate and reliable results.

• Prepare detailed reports and documentation that meet regulatory standards for validation studies, including protocol development, execution, and results analysis

• Lead and/or coordinate equipment and instrumentation IQ/OQ/PQ for GMP validated testing

• Lead Microbial Feedstock production and analytics

• Act as the Lab Biosafety Officer and Biosafety committee member

• USP Equipment Maintenance (incubators, Bioreactors, BSCs, Nut/met)

• The ideal candidate will also be willing to contribute to new R&D projects focused on filtration and medical diagnostics, by designing, performing, and analyzing experiments, utilizing advanced scientific techniques and equipment

• Adherance to all safety rules, including the wearing of PPE (personal protective equipment)

Qualifications

• BS/BA in Micro/Cell biology, Biotechnology or related field with 1-5 years experience.

• Strong understanding of GMP guidelines, regulatory requirements, and quality control processes related to microbial control and filtration.

• Experience with Bacterial culture methods, identification, and titer analytics (e.g. counting, LRV, serial dilutions, Gram staining, biochemical tests)

• Experience in Biological Analytical Assay Development

• Experience authoring Standard Operating Procedures (SOPs) and supporting Quality Documentation

• Experience Aseptic handling techniques and Filtration.

• Experience with data analysis and statistical software tools (Excel, Minitab)

• Excellent analytical, problem-solving, and communication skills.

• Ability to work independently and as part of a team in a fast-paced environment.

• Experience leading Upstream GMP test method development, validation, and documentation for liquid filtration products is a plus

• Experience with project management and managing technicians is a plus

• Experience with Process scale Filtration processing is a plus