Senior HPAPI Process Development Scientist - Flexible Hours

Sterling Pharma Solutions; Town of Germantown (WI); Hybrid; USD 140,000 - 195,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Life Insurance

Paid Time Off

Bonus Program

401k Match

Tuition Reimbursement

EAP

Flexible Hours

Career Training

Job summary

Sterling Pharma Solutions in Germantown, WI is seeking a Senior/Principal Process Development Scientist to drive HPAPI process development from lab to cGMP transfer, focusing on highly potent compounds, payloads and ADC payloads.

You will lead cross-functional teams, design scalable routes, perform DOE studies, and prepare development reports and tech transfer documents for clients and regulatory filings. The role emphasizes containment, safety, and collaboration in a fast-paced CDMO environment.

Qualifications

• Experience in synthetic route development, reaction optimization, and scale-up for HPAPIs.
• Experience with highly potent compounds, containment, and safe laboratory practices.
• Minimum education and years: 15+ years with Bachelor's, 9+ with Master's, or 5+ with PhD.

Responsibilities

• Lead process development for HPAPIs from lab to manufacturing transfer.
• Perform DOE and impurity studies to understand and control critical parameters.
• Support lab-to-plant scale-up and containment, collaborating across teams.
• Design multi-step syntheses for HPAPI payloads, linkers, and intermediates.
• Prepare development reports, specifications, and technology transfer documents.

Skills

HPAPI development

Process design & optimization

DOE experiments

Tech transfer documentation

Regulatory/cGMP knowledge

Project leadership

Education

Bachelor's degree in Chemistry or related field

Master's degree in Chemistry or related field

PhD in Organic Chemistry or related field

Tools

HPLC

NMR

LC-MS

GC

Preparative chromatography

Job description

Sterling Pharma Solutions in Germantown, WI is seeking a Senior/Principal Process Development Scientist to drive HPAPI process development from lab to cGMP transfer, focusing on highly potent compounds, payloads and ADC payloads.

You will lead cross-functional teams, design scalable routes, perform DOE studies, and prepare development reports and tech transfer documents for clients and regulatory filings. The role emphasizes containment, safety, and collaboration in a fast-paced CDMO environment.