Analytical Chemist
Hubot | Tri Pac, Inc. CDMO · South Bend, IN · 1 mo ago
On-siteManufacturingFull-time
About HubotHubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) serving global pharmaceutical and personal care brands — including Fortune 500 clients. With 25–30% projected year-over-year growth through 2030, we're building the infrastructure, systems, and team to match world-class ambition.⭐ 4.8 Glassdoor | 4.7 Indeed | 95% Employee Recommendation Rate This position is not eligible for visa sponsorship. Why Hubot ?🚀 Growth-Stage Opportunity We're forecasting 25–30% year-over-year revenue growth through 2030. This is a rare chance to join a scaling CDMO where your contributions directly shape laboratory capabilities not just maintain them.🌐 Real Client Impact You'll work on products that ship to Fortune 500 pharmaceutical and personal care brands. Your analytical work isn't academic it releases product, supports regulatory submissions, and protects patients and consumers.🔬 Regulated Industry Depth Our laboratory operates under FDA 21 CFR 210/211, ISO 13485, ISO 9001, ISO 14001 and ISO 22716 cGMP standards. You'll sharpen expertise in frameworks that are valued across the global pharmaceutical and personal care supply chain.💻 Ownership Over Systems, Not Just Instruments You'll hold supervisory sign-off authority in LIMS, author the SOPs your team works from, and drive method development from concept through validation with real technical autonomy.📈 A Defined Path Forward We promote from within. Strong performers move into Principal Chemist, Method Development Lead, and ultimately Analytical Sciences Manager with mentorship from senior technical leadership and visibility across client programs from day one. The OpportunityWe're hiring a Analytical Chemist to serve as a technical anchor in our method development and analytical sciences function. This is a hands-on, high-ownership role you'll independently develop, validate, and troubleshoot complex analytical methods, mentor junior scientists, and serve as a trusted point of contact for internal teams and external clients alike.This is not a routine testing position. We're looking for someone who is energized by complex problems, takes pride in airtight documentation, and wants to do meaningful work with real pharmaceutical and consumer products that reach patients and consumers every day. What You'll Own 🔬 Method Development & ValidationIndependently develop, evaluate, validate, and verify analytical methods across chromatographic and spectrophotometric platforms HPLC, GC, UV/Vis, FTIR, and titrationApply methods to excipients, new chemical entities, drug products, and stability samplesSupport cleaning validation method development and associated sample testingServe as the go-to troubleshooting resource for method performance issues — identify root causes, document critical factors, and resolve problems efficiently and cost-effectively 📊 Data Integrity & ReportingInterpret complex data sets, compare results against specifications, and prepare clear, defensible reportsTrend data to proactively flag concerns and identify process improvement opportunitiesAuthor SOPs, analytical testing procedures, batch release testing forms, and document templates for team-wide useServe as the site's resident LIMS expert, including supervisory sign-off authority for electronic reports 🏭 Laboratory Operations & QualityEnsure proper use, calibration, and care of reference standards, timers, thermometers, and analytical instrumentationFollow all method instructions and internal SOPs to minimize repeat testing, deviations, and investigationsReview routine laboratory work completed by junior analysts for accuracy and GMP complianceSupport laboratory management in the preparation and execution of investigations, deviations, and CAPA 🤝 Client & Team CollaborationServe as a technical point of contact for laboratory testing support providing timely, clear updates to supervisors and clientsSupport scheduling and planning of internal and external client project work to maintain efficiency and quality standardsIdentify and recommend improvements in laboratory workflow, turnaround time, and client serviceMentor and onboard new laboratory team members, building a culture of quality and continuous improvement What You BringBachelor's degree or higher in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related field3+ years of analytical chemistry experience in a GMP/GLP-regulated environment pharmaceutical, CDMO, medical device, or OTC consumer productsDirect, independent ownership of method development and validation not just routine testing executionProficiency with HPLC, GC, and FTIR; familiarity with USP/NF compendial methods and ICH Q2(R1) validation guidelinesExperience with LIMS platforms and comfort with 21 CFR Part 11 electronic records environmentsStrong technical writing skills across SOPs, method protocols, and investigation reportsDetail-oriented, self-directed, and capable of managing multiple priorities without losing accuracy Preferred:Experience in a CDMO or pharmaceutical contract laboratory settingAnalytical support for cleaning validation programsOTC drug product or personal care product testing backgroundPrior experience mentoring or providing technical review for junior analystsExposure to aerosol or liquid dosage form testing How We Measure SuccessMethod validation packages completed on time and fully compliant with ICH/USP requirementsZero data integrity findings during internal or external auditsOn-time delivery of testing results and client-facing reportsEffective CAPA closure for laboratory investigations and deviationsMeasurable growth of junior team members through active mentorship What We OfferCompetitive base salary commensurate with experienceMedical, dental, and vision insurance401(k) with company contributionPaid time off and holidaysShort- and long-term disability coverageProfessional development and certification support Apply TodayCome do science that ships. Real products. Real clients. Real impact. 🌐 www.hubot.usHubot, 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