Position Details

Salary $117K – $184K USD / year

Type Full-Time

Experience mid

Exp. Years 4 years

Education BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical Engineering

Category Engineering (Non-Software)

About this role

Senior Scientist, Engineering- Small Molecule Drug Substance Process Development develops and optimizes manufacturing processes for small molecules in a collaborative, cGMP-compliant environment, including tech transfer to pilot and production facilities.

Key Responsibilities

Process development experiments
Scale-up and technology transfer
Regulatory filing support
Cross-functional collaboration
Maintain GDP and data integrity

Technical Overview

Role spans bench and kilo labs with emphasis on chemical process development, chromatographic operations, scale-up, and regulatory documentation; requires cross-functional collaboration and adherence to cGMP.

Ideal Candidate

The ideal candidate is a mid-to-senior scientist with hands-on chemical process development in small molecule drug substance, strong understanding of cGMP and scale-up, and ability to lead cross-functional technology transfer initiatives.

Must-Have Skills

BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical EngineeringExperience in chemical process developmentcGMP complianceDOEProcess scale-upTechnology transfer

Nice-to-Have Skills

Experience performing regulatory filing/validation planningKnowledge of QbD (Quality by Design)Pilot plant experienceMathematical modeling

Tools & Platforms

HPLCSDS-PAGEUV-VisLight Scattering

Required Skills

BioreactorscGMP RegulationsChemical EngineeringChemical TechnologyChromatographic TechniquesData AnalysisDesign of Experiments (DOE)GMPManufacturing ProcessesProcess DevelopmentProcess OptimizationProcess Scale UpSmall MoleculesTechnology Transfer

Hard Skills

BioreactorscGMP RegulationsChemical EngineeringChemical TechnologyChromatographic TechniquesData AnalysisDesign of Experiments (DOE)Good Manufacturing Practices (GMP)Manufacturing ProcessesProcess Development (PD)Process OptimizationProcess Scale UpSmall MoleculesTechnology Transfer

Soft Skills

AdaptabilityCommunicationCollaborationInterpersonal RelationshipsTime ManagementDetail-Oriented

Industry & Role

Industry Healthcare & Medical

Job Function Develop and optimize small molecule drug substance processes from lab to production scale.

Clearance & Visa

Visa Sponsorship Yes

Keywords for Your Resume

bioreactorscGMP regulationschemical engineeringchemical technologychromatographic techniquesdata analysisdesign of experimentsGMPmanufacturing processesprocess developmentprocess optimizationprocess scale upsmall moleculestechnology transferregulatory filingvalidation planningpilot plantcGMPsafety compliancecross-functionalchemical process developmentDOEprocess scale-uptech transferHPLCQA documentation

Deal Breakers

Lack of experience in small molecule process development, No exposure to cGMP manufacturing, Inability to operate in hybrid work model, No BS/MS/PhD in relevant fields

Apply for this Position →

Get matched to jobs like this

Luna finds roles that fit your skills and career goals — no endless scrolling required.

Create a Free Profile