Analytical Scientist IV – API Method Development & Scale-Up

BioSpace; Indiana; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Healthcare options

Retirement savings plans

Job summary

USP in Indiana is seeking a Scientist IV to support process development and scale-up of APIs and related materials. The role focuses on analytical method development and evaluation for in-process samples, plus routine and non-routine analytical testing within a GLP-compliant lab environment.

The successful candidate will guide complex projects, collaborate with scientists and USP personnel, and help ensure high-quality standards for global health applications.

Qualifications

• Hands-on experience with chemical methods and instrument handling (HPLC, GC, LC-MS, GC-MS, FTIR, UV-Visible, wet chemistry).
• Experience in analytical testing and development with focus on process analytical chemistry.
• Ability to perform analytical method development and validation as required.
• Excellent technical writing and verbal communication skills.
• Good interpersonal skills and ability to work in a team.
• We especially welcome applications from historically marginalized and/or underrepresented identities.

Responsibilities

• Support reaction monitoring, scale-up and final analysis of samples per monograph/in-house procedures, including method development/validation if required.
• Plan, execute and complete projects per specifications, timelines and budget.
• Prepare and review SOPs, protocols, and reports.
• Coordinate with external vendors and internal departments to meet project requirements.
• Maintain equipment maintenance/calibration; IQ/OQ/PQ of new instruments as assigned.
• Assist ISO-9001 certification efforts and participate in QA audits.

Skills

Analytical method development

Method validation

Technical writing

Verbal communication

Team collaboration

Education

Analytical Chemistry/M.Pharm degree or PhD

Tools

HPLC

GC

LC-MS

GC-MS

FTIR

UV-Vis

Wet chemistry

Job description

USP in Indiana is seeking a Scientist IV to support process development and scale-up of APIs and related materials. The role focuses on analytical method development and evaluation for in-process samples, plus routine and non-routine analytical testing within a GLP-compliant lab environment.

The successful candidate will guide complex projects, collaborate with scientists and USP personnel, and help ensure high-quality standards for global health applications.