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 bi…
Skills: Analytical data review, Quality control, cGMP, GLP, ALCOA+
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 bi…
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Lexington Medical, Inc
Senior Manufacturing Engineer
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Lexington Medical, Inc
Quality Control Technician
Bedford, England, United Kingdom · On-site
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Weekend Community Care Companions in Bedford - Be a Weekend Warrior of Care!
Bedford, England, United Kingdom · On-site
Entry level
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Lexington Medical, Inc
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Bedford, England, United Kingdom · On-site
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Lexington Medical, Inc
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Weekend Community Care Companions in Bedford - Be a Weekend Warrior of Care!
Bedford, England, United Kingdom · On-site
Entry level
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Weekend Community Care Companions in Bedford - Be a Weekend Warrior of Care!
Bedford, England, United Kingdom · On-site
$15/hr–$25/hr
Entry level
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$98k–$113k/yr
Full-time
bachelor degree
Posted 13d ago
~40 hrs/week
Responsibilities
The Data Review Specialist is responsible for performing thorough reviews of analytical chemistry, microbiology, and stability data to ensure compliance with cGMP and GLP standards. This role also involves monitoring data trends to identify atypical results and collaborating with cross-functional teams to support batch release and regulatory submissions.
Requirements
Candidates must hold a bachelor's degree in a scientific discipline such as Chemistry or Microbiology and possess at least 5 years of experience in a GMP-regulated QC environment. Proficiency in data integrity expectations, chromatography software, and electronic data management systems is required.
Full job description
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 Data Review Specialist will apply strong technical knowledge of laboratory operations, analytical data review, data integrity requirements, and quality systems to perform thorough reviews of analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations. This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing.
In addition to data review, this role will support QC data monitoring activities, including evaluation of release data, raw material testing data, and stability data trends to identify emerging patterns, atypical results, potential OOT signals, and opportunities for improved product understanding. The Data Review Specialist will serve as a trusted partner to QC, QA, Stability, Manufacturing, Supply Chain, and Analytical Development stakeholders.
Key Responsibilities:
Quality Control Data Review
Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing) to ensure accuracy in calculations, instrument suitability, standards, sequences, and chromatographic integration.
Review and support trending of stability data across applicable drug products, raw materials, and device-related attributes to identify emerging trends, atypical results, potential OOT signals, and data patterns requiring escalation.
Assist with interpretation of stability data in support of timepoint completion, stability reports, annual product reviews, regulatory submissions, and product lifecycle monitoring.
Support monitoring of released testing data for commercial and clinical batches, including review of assay, impurities/degradation products, dissolution/drug release, microbiological, and device performance data where applicable.
Collaborate with QC Stability, Raw Materials, QA, Manufacturing, Supply Chain, and Analytical Development to evaluate data trends and determine whether observed patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
Support trending and monitoring of raw material data, including supplier lot-to-lot variability, retest/expiry data, CoA verification trends, and recurring analytical or documentation issues.
Documentation & Compliance
Ensure reviewed data packages meet cGMP, GLP, FDA/EMA, internal SOP, ALCOA+, and data integrity expectations for lot release, stability, raw materials, device testing, method validation, and regulatory support. Conduct timely and thorough review of data packages to support lot release, stability pulls, device testing, and method verification/validation activities.
Identify and document discrepancies, atypical results, potential data integrity concerns, and review comments; work with QC, QA, and originating groups to resolve issues in a timely manner.
Support OOS, OOT, deviations, CAPAs, audits, APR/PQR inputs, and regulatory requests by evaluating analytical, microbiological, stability, release, and raw material data for trends, anomalies, or potential root causes.
Quality Systems & Continuous Improvement
Recommend and support improvements to data review workflows, documentation templates, JPM, LIMS/Empower interfaces, Smartsheet trackers, and data integrity practices.
Generate and maintain reports, trackers, dashboards, and KPIs to support QC management review, workload visibility, product quality monitoring, and continuous improvement initiatives.
Serve as a technical resource to QC analysts by reinforcing best practices in documentation, audit trail review, ALCOA+ expectations, data monitoring, and inspection readiness
Cross-Functional Collaboration
Work cross-functionally with QC Chemistry, Raw Materials, Analytical Development, QC Microbiology, QA, Manufacturing, Supply Chain, and Product Development groups.
Communicate delays, data discrepancies, and potential risks to QC and QA leadership promptly.
Support cross-functional data requests related to product release, investigations, validations, or regulatory submissions.
Qualifications:
Bachelor’s degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline.
5+ years in a QC laboratory, or data review role or a similar GMP-regulated environment, with a track record of strong performance, reliability, and increasing responsibility.
Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+).
Ability to independently review laboratory data, identify discrepancies, and collaborate effectively with peers and stakeholders to resolve issues in a timely manner.
Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility).
Familiarity with chromatography software (e.g., Empower) and microbiology testing documentation.
Proficiency with electronic data management systems, including JPM, LIMS, Smartsheets and Empower.
Familiarity with statistical software, JMP preferred.
Prior experience with method validation and stability study protocols is a plus.
#LI-LM1
Salary Range
$98,000—$113,000 USD
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes. AXPAXLI™ (also known as OTX-TKI), an investigational axitinib hydrogel administered by intravitreal injection, is Ocular’s leading investigational candidate for retinal disease, based on its proprietary ELUTYX™ technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and has potential applications across other retinal diseases such as non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME).
Offices: 15 Crosby Drive, Bedford, MA 01730, US
RetinaRetinal DiseaseWet AMDNPDRDMEAnti-VEGFTyrosine Kinase InhibitorsOcular Drug DeliverySustained DeliveryOphthalmic Therapies
How many Healthcare jobs are open in Bedford, United Kingdom right now?
There are currently 62 open healthcare positions in Bedford, United Kingdom listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Bedford, United Kingdom?
Companies currently hiring include The Edinburg Center, Ocular Therapeutix, Inc., Ultragenyx, Home Instead, Lexington Medical, Inc, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Bedford, United Kingdom?
Yes — 8 of the 62 open healthcare positions offer remote or hybrid work (0 remote, 8 hybrid).
How do I apply for Healthcare jobs in Bedford, United Kingdom?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.