Analytical R&D Scientist — Process Development & Scale-Up

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

Job summary

USP is seeking a Scientist IV to support process development and scale-up of APIs and related materials in analytical chemistry. The role involves method development, in-process testing, and routine and non-routine analytical work within a GLP-compliant lab.

You will collaborate with scientists and USP personnel to drive project outcomes, participate in ISO-9001 activities, and contribute to public health standards and quality assurance initiatives.

Qualifications

• Hands-on experience in analytical research and development in pharma.
• Experience with analytical method development and validation.
• Familiarity with quality systems (GLP, ISO-9001) and cGXP.
• Strong technical writing and data interpretation skills.
• Ability to work in cross-functional teams and manage projects.

Responsibilities

• Support reaction monitoring, scale-up and final analysis per procedures.
• 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 requirements.
• Maintain equipment maintenance and calibrations; IQ/OQ/PQ of new instruments.
• Assist ISO-9001 certification/recertification activities and audits.
• Maintain GLP and safety procedures in the lab.
• Contribute to lab management activities and cross-functional collaboration.
• Promote Diversity, Equity, Inclusion & Belonging in the team.

Skills

Technical writing

Verbal communication

Team collaboration

Project management

Education

Bachelor-level degree in Analytical/Organic Chemistry or M.Pharm

PhD in Analytical Chemistry or related field

Tools

HPLC

GC

LC-MS

GC-MS

FTIR

UV-Visible

Wet chemistry

Job description

USP is seeking a Scientist IV to support process development and scale-up of APIs and related materials in analytical chemistry. The role involves method development, in-process testing, and routine and non-routine analytical work within a GLP-compliant lab.

You will collaborate with scientists and USP personnel to drive project outcomes, participate in ISO-9001 activities, and contribute to public health standards and quality assurance initiatives.