Quality Control Principal Analyst, Microbiology

Ocular Therapeutix•Bedford, MA

6d•$135,000 - $145,000•Onsite

About The Position

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary : The Quality Control (QC) Principal Analyst, Microbiology is responsible for overseeing and coordinating microbiological activities to support the release and testing of in-process samples in compliance with cGMP and regulatory requirements. This role provides technical expertise in microbiological testing and environmental monitoring (EM), and contamination control strategies, ensuring high quality standards across the laboratory. The QC Principal Analyst, Microbiology drives continuous improvement, ensures timely execution of testing, supports deviation/investigation resolution, and assists in the development and training of junior analysts. This position serves as a key liaison between QC, Manufacturing, Quality Assurance, and other cross-functional teams to ensure seamless laboratory operations and compliance.

Requirements

Bachelor’s degree in microbiology, biology, or a related scientific discipline is required
6-8+ years of relevant laboratory experience in a GMP-regulated pharmaceutical, biotech, or medical device environment is required
Strong proficiency in aseptic techniques and microbiology test methodologies (including bioburden, endotoxin and sterility testing) as well as an expert understanding of cGMP, USP, and regulatory guidelines (e.g., FDA, EMA)
Excellent communication and leadership skills are necessary

Nice To Haves

Prior experience performing method development/method transfer/method verification of microbial assays
Proficiency with LIMS, EM software, and Microsoft Office suite

Responsibilities

Spearhead and write EM trend reports and perform trend analysis
Manage and write EM excursion investigation reports, OOS and OOT investigations
Create and maintain database of EM data tracking and trends
Write and support laboratory investigations, deviations, CAPAs, and change controls
Coordinate and work with vendors to schedule testing requirements and turnaround time commitments
Conduct routine and non-routine analysis of microbiology methods in accordance with standard operating procedures (SOP’s) or compendial methods
Serve as a subject matter expert (SME) for microbiological methods, aseptic techniques, and contamination control
Review and approve microbiological data, ensuring accuracy, completeness, and compliance with cGMP and regulatory standards
Receive test results/data from contract laboratories and perform data review and entry into the appropriate database
Mentor and train junior analysts, providing technical guidance and performance feedback
Create new SOP’s and work instructions and update or revise existing SOP’s and other controlled documents as required for continuous improvement, gap assessment, or in-house testing transfer support
Perform individual projects independently with supervision
Train and mentor junior analysts on microbiological techniques and GMP practices
Support method validation, equipment qualification, and implementation of new technologies
Participate in internal and external audits and regulatory inspections, preparing documentation and responding to inquiries
Contribute to continuous improvement initiatives and process optimization
Collaborate with cross-functional teams (e.g., Manufacturing, Quality Assurance, and Regulatory) to support product lifecycle and quality initiatives