QC Micro Associate II

Job Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform, Encapsulated Cell Technology (ECT), designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, by leveraging ECT's innovative approach providing sustained, targeted treatment directly to the eye.

We are currently seeking to add a QC Microbiology & EM Associate II who will be involved in the development and execution of microbiological testing and environmental monitoring activities to ensure compliance with regulatory requirements and quality standards. This position offers an excellent opportunity for experienced analysts to continue their growth and maturity in GxP and Quality Control functions within a compliance-focused, patient-centric environment.

The QC Micro Associate II plays a critical role in maintaining the highest standards of product quality and contamination control within our manufacturing facility and cleanrooms. This role provides support within the laboratory and cleanrooms in various functions including the receipt, processing, testing, inventory, and maintenance needs to ensure the laboratories comply with regulatory standards and internal quality specifications for product and materials.

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

Job Requirements

Work collaboratively with other QC team members and departments to identify issues, remediate as appropriate, and improve processes.

Participate in training programs and maintain knowledge of current QC, Microbiology, and contamination control practices and regulations.

Support growth of junior analysts by providing SME training, where appropriate.

Support compliance with regulatory authorities and guidelines.

Maintaining the laboratories in audit-ready state.

Support internal and external audits.

Foster relationships with external suppliers and contract testing laboratories, including support with Supplier and Vendor Qualification and ensuring adherence to established Quality Agreements.

Works closely with Facilities to support scheduled and unscheduled equipment maintenance.

Engage with Warehouse & Logistics department to ensure external laboratory testing samples are shipped and received promptly and accurately.

Supports routine laboratory testing, sampling, peer review, and reporting.

Routine and Dynamic EM support in sampling, reviewing, and reporting results. Assist in investigations as needed.

Sampling, testing, review, and reporting of Purified Water and Utility Gases. Assist in investigations as needed.

Assist senior roles in development and improvement of existing or new methods.

Prepares samples for analysis, ensuring adherence to procedures and maintaining sample and data integrity.

Maintain laboratories in 5S state. Holds ownership of specific areas of expertise within laboratories.

Assists in the routine cleaning and maintenance of laboratory equipment to ensure optimal performance and compliance with quality standards.

Support Sample Management in receipt, process, and purging of materials and test samples.

Conducts routine testing including but not limited to, Bacterial Endotoxins, Growth Promotion, Sterility, Bioburden, Method Development and Validation, and other relevant functions, in accordance with established protocols and procedures.

Maintain laboratory records in compliance with GDP, GMP, GLP, and associated regulatory guidelines.

Responsible for quality systems management and support including Laboratory Investigations, OOSs, OOTs, Deviations, CAPAs, Effectiveness Checks, Change Controls, Regulatory Submissions, and Test Method Development.

Education & Experience

Bachelor of Science in Microbiology, Biology, or related science degree.

2 - 4 years of relevant laboratory experience, preferably in a pharmaceutical or biotechnology setting. Internship or co-op experience may be considered

Knowledge, Skills & Abilities

Strong knowledge of microbiological principles and testing techniques, including aseptic techniques, relevant regulatory guidelines, Release and Stability DS and DP testing.

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

Trending and review of EM and testing results to ensure processes remain in a state of control. Provide support in creating efficiencies and building new processes, where necessary.

Experience in laboratory equipment and software for data management (e.g., LIMS, QMS).

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

Strong attention to detail and ability to maintain accurate and organized records and follow protocols precisely.

Excellent communication skills both, verbal and written.

Ability to work both independently and collaboratively in a team environment.

Ability to lead and foster professional growth for junior analysts.

Familiarity with GMPs, GLPs, GDPs, and industry guidelines, including USP, FDA, EU, ISO, and ICH.

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.

Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Full-time