Analytical Chemist

Hubot | Tri Pac, Inc. CDMO; South Bend (IN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

401(k) with company contribution

Paid time off & holidays

Disability coverage

Professional development

Job summary

Hubot, Inc. in Indiana seeks an Analytical Chemist to lead method development and validation within a regulated CDMO environment. This hands-on role develops and troubleshoots complex analytical methods, mentors junior scientists, and supports regulatory submissions.

You will work with HPLC, GC, FTIR, and LIMS, ensuring GMP compliance, authoring SOPs, and delivering clear, defensible analytical reports for internal and external stakeholders.

Qualifications

• Bachelor's degree or higher in Chemistry or closely related field.
• 3+ years of analytical chemistry experience in GMP/GLP-regulated environment.

Responsibilities

• Independently develop, evaluate, validate, and verify analytical methods across chromatographic and spectrophotometric platforms (HPLC, GC, UV/Vis, FTIR).
• Apply methods to excipients, new chemical entities, drug products, and stability samples.
• Support cleaning validation method development and associated testing.
• Author SOPs, testing procedures, and reports for regulatory submission and QA.
• Mentor junior scientists and serve as technical point of contact for clients and internal teams.

Skills

Analytical thinking

Detail-oriented

Technical writing

Education

Bachelor's degree in Chemistry or related

Tools

HPLC

GC

FTIR

LIMS

Job description

Hubot, 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.

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 Opportunity

We'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

• Independently develop, evaluate, validate, and verify analytical methods across chromatographic and spectrophotometric platforms HPLC, GC, UV/Vis, FTIR, and titration
• Apply methods to excipients, new chemical entities, drug products, and stability samples
• Support cleaning validation method development and associated sample testing
• Serve as the go-to troubleshooting resource for method performance issues - identify root causes, document critical factors, and resolve problems efficiently and cost-effectively
• Interpret complex data sets, compare results against specifications, and prepare clear, defensible reports
• Trend data to proactively flag concerns and identify process improvement opportunities
• Author SOPs, analytical testing procedures, batch release testing forms, and document templates for team-wide use
• Serve as the site's resident LIMS expert, including supervisory sign-off authority for electronic reports

Laboratory Operations & Quality

• Ensure proper use, calibration, and care of reference standards, timers, thermometers, and analytical instrumentation
• Follow all method instructions and internal SOPs to minimize repeat testing, deviations, and investigations
• Review routine laboratory work completed by junior analysts for accuracy and GMP compliance
• Support laboratory management in the preparation and execution of investigations, deviations, and CAPA
• Serve as a technical point of contact for laboratory testing support providing timely, clear updates to supervisors and clients
• Support scheduling and planning of internal and external client project work to maintain efficiency and quality standards
• Identify and recommend improvements in laboratory workflow, turnaround time, and client service
• Mentor and onboard new laboratory team members, building a culture of quality and continuous improvement

What You Bring

• Bachelor's degree or higher in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related field
• 3+ years of analytical chemistry experience in a GMP/GLP-regulated environment pharmaceutical, CDMO, medical device, or OTC consumer products
• Direct, independent ownership of method development and validation not just routine testing execution
• Proficiency with HPLC, GC, and FTIR; familiarity with USP/NF compendial methods and ICH Q2(R1) validation guidelines
• Experience with LIMS platforms and comfort with 21 CFR Part 11 electronic records environments
• Strong technical writing skills across SOPs, method protocols, and investigation reports
• Detail-oriented, self-directed, and capable of managing multiple priorities without losing accuracy

Preferred:

• Experience in a CDMO or pharmaceutical contract laboratory setting
• Analytical support for cleaning validation programs
• OTC drug product or personal care product testing background
• Prior experience mentoring or providing technical review for junior analysts
• Exposure to aerosol or liquid dosage form testing

How We Measure Success

• Method validation packages completed on time and fully compliant with ICH/USP requirements
• Zero data integrity findings during internal or external audits
• On-time delivery of testing results and client-facing reports
• Effective CAPA closure for laboratory investigations and deviations
• Measurable growth of junior team members through active mentorship

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
• Professional development and certification support

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