QC Microbiology & Environmental Monitoring Associate III

Job Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are seeking a highly motivated and detail-oriented individual to join our Quality Control (QC) team The QC Microbiology and Environmental Monitoring Associate plays a crucial role in maintaining the highest standards of product quality and environmental safety within our manufacturing facilities. This position is responsible for overseeing microbiological testing and environmental monitoring activities to ensure compliance with regulatory requirements and company standards.

This is an on-site role in Cumberland, RI. This is not a hybrid or remote opportunity.

Also, please note this role is not eligible for agency recruiting support.

Job Requirements

Microbiological Testing: Perform and oversee microbiological testing of raw materials, in-process samples, finished products, and environmental samples using a variety of techniques such as bioburden testing, microbial identification, endotoxin testing, and sterility testing.

Environmental Monitoring: Design, implement, and manage environmental monitoring programs to assess the cleanliness and microbial control within manufacturing areas. Conduct routine monitoring of air, surfaces, water systems, and personnel to detect and mitigate potential sources of contamination.

Method Development and Validation: Develop and validate microbiological testing methods in accordance with regulatory guidelines and industry best practices. Evaluate and implement new technologies to improve efficiency and sensitivity of testing procedures.

Data Analysis and Reporting: Analyze microbiological data and trends to identify areas for improvement and ensure compliance with specifications and acceptance criteria. Prepare and maintain accurate records of testing results, deviations, and investigations in compliance with cGMP requirements.

Investigations and CAPAs: Participate in investigations into microbiological deviations, out-of-specification results, and environmental excursions. Develop and implement corrective and preventive actions (CAPA) to address root causes and prevent recurrence of issues.

Quality Systems Support: Provide support for quality systems related to microbiology and environmental monitoring, including document control, change control, and training. Participate in internal and external audits and assist in implementing audit findings and recommendations.

Collaboration and Communication: Collaborate cross-functionally with manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and effective communication of microbiological and environmental monitoring requirements. Communicate effectively with stakeholders to provide updates on testing activities, results, and compliance status.

Education & Experience

Bachelor's or master’s degree in Microbiology, Biology, Biochemistry, or related field.

Minimum of 3 years of experience in microbiology and environmental monitoring within a biopharmaceutical or pharmaceutical industry.

Certification in Microbiology, such as ASM or RMM, is preferred.

Knowledge, Skills & Abilities

Strong knowledge of microbiological testing techniques, including aseptic technique, microbial enumeration, identification, and sterility testing.

Experience with environmental monitoring programs, including air and surface sampling, viable and non-viable particle counting, and water system monitoring.

Experience with quality systems (e.g., document control, change control, deviation management) and electronic systems (e.g., LIMS, QMS) is a plus.

Familiarity with regulatory requirements and guidelines, including USP, FDA, and EU GMP regulations.

Experience with method development, validation, and qualification of microbiological testing methods.

Excellent analytical, problem-solving, and decision-making skills.

Strong attention to detail and ability to maintain accurate and organized records.

Effective communication skills and ability to work collaboratively in a team environment.

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible! And that’s just the beginning.

Do you share our vision?

Applications are currently being accepted through the Neurotech Career Center.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.