Analytical Chemist: Method Development Lead (GMP)

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. 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.