R&D Chemist - Stability Coordinator

R\&D Chemist – Stability Coordinator

Hubot, Inc. \| Winchester, Virginia \| Full-Time \| On-Site

Reports to: R\&D Manager

This position is not eligible for visa sponsorship. Applicants must be authorized to work for any U.S. employer.

About Hubot

Hubot, Inc. is an FDA-registered CDMO headquartered in South Bend, Indiana, specializing in liquid and aerosol filling for global pharmaceutical and personal care brands including Fortune 500 clients across consumer health, beauty, and personal care. ⭐ 4\.8 Glassdoor \| 4\.7 Indeed \| 95% Employee Recommendation Rate

The Opportunity

We're hiring an

R\&D Chemist – Stability Coordinator

to own and operate the stability program at our Winchester, Virginia facility. This is a dual-function role — you'll coordinate all stability activities across OTC, cosmetic, and medical device product lines while supporting active formulation development projects in the R\&D lab.

You'll be the primary point of contact for all stability programs at the site, working cross-functionally with R\&D, QC, and production to keep studies on schedule, data trends identified early, and regulatory requirements met.

If you take pride in meticulous program management, thrive in a GMP-regulated lab environment, and want to do meaningful work on products that reach consumers every day — this role is worth a close look.

Why Hubot

🚀

Growth-Stage Opportunity

Join a scaling CDMO at a pivotal moment with 25–30% projected YoY growth through 2030, you'll have real influence over how systems and programs develop.

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Dual-Function Depth

This role sits at the intersection of stability science and formulation development giving you breadth across OTC, cosmetic, and medical device product categories.

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Regulated Industry Experience

Our operations run under FDA 21 CFR 210/211, ICH stability guidelines, ISO 13485, ISO 9001, ISO 14001, GMP, Health Canada and ISO 22716 cGMP standards sharpening expertise that travels across the industry.

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Cross-Functional Visibility

You'll work directly with R\&D, QC, and production leadership with clear visibility and direct impact on product quality and client deliverables.

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Defined Path Forward

Strong performers grow into Senior R\&D Chemist, Stability Lead, or R\&D Project Manager with mentorship from site and U.S. leadership.

What You'll Own

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Stability Program Management

• Serve as the primary site authority for all stability programs across OTC, cosmetic, and medical device product lines
• Initiate stability studies, author protocols, coordinate sample pulls, and ensure testing schedules are met across routine campaign and non-routine project studies
• Analyze stability data, evaluate trends, and author interim and final stability reports in compliance with FDA ICH guidelines and internal SOPs
• Maintain the site stability tracker for routine annual and lab stability studies
• Escalate emerging trends to the R\&D Manager and support investigations based on test data
• Manage stability-related deviations, CAPAs, and change controls through to closure
• Coordinate shipment of stability samples to external laboratories as required
• Collaborate with QC laboratories to ensure stability samples are tested within specified timeframes for actives and microbiology
• Support business requests related to stability data including temperature excursion assessments, regulatory requests, and investigational work

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Formulation Development Support

• Support R\&D lab formulation development activities for OTC, cosmetic, and medical device products across aerosol, liquid, and bag-on-valve (BOV) formats
• Lead formulation development projects with stability as the primary lens — designing studies that anticipate shelf-life and regulatory requirements from the outset
• Support improvement of existing product formulations based on stability data and trend analysis
• Perform routine lab testing including viscosity, pH, specific gravity, and API characterization

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Data Management \& Reporting

• Report stability data trends through structured data management and trend analysis using appropriate software
• Maintain accurate and audit-ready study documentation in compliance with GMP and GLP requirements
• Proficiently manage stability and project documentation using Microsoft 365

What You Bring

• Associate's or Bachelor's degree (B.A. or B.S.) in Chemistry, Pharmaceutical Sciences, or a related scientific discipline
• 2\+ years of experience in a GMP-regulated laboratory environment
• Direct experience coordinating or conducting stability studies - including protocol authoring, sample scheduling, data analysis, and report writing
• Working knowledge of FDA ICH stability guidelines (Q1A-Q1F) and GMP/GLP requirements
• Familiarity with common analytical techniques - viscosity, pH, specific gravity, API testing
• Experience with stability-related deviations, CAPAs, and change control processes
• Strong organizational skills with demonstrated ability to manage multiple concurrent studies and deadlines
• Proficiency with Microsoft 365

Preferred:

• Experience with OTC drug products, cosmetics, or medical device product categories
• Familiarity with aerosol, liquid, or BOV dosage form development
• Knowledge of statistical methods applied to stability trend analysis
• Prior experience coordinating external laboratory shipments and testing schedules

How We Measure Success

• Stability study initiation and sample pull schedule adherence
• On-time delivery of stability reports and regulatory data packages
• Zero audit findings on stability documentation and study execution
• CAPA and deviation closure rate for stability-related quality events
• Formulation development milestone adherence in support of R\&D project timelines

What We Offer

• Competitive base salary commensurate with experience
• Medical, dental, and vision insurance
• 401(k) with company contribution
• Paid time off and holidays
• Short and long-term disability coverage
• Education assistance program for continued personal and professional development
• Ongoing technical training and certification support

Apply Today

Come build programs that protect products and the people who use them.

🌐 www.hubot.us

Hubot, Inc. is an Equal Employment Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.