Senior HPAPI Process Development Scientist

Sterling Pharma Solutions; Town of Germantown (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/dental/vision/life insurance

Bonus program

401k match

Tuition reimbursement

Flexible work hours

Career training and development

Job summary

Sterling Pharma Solutions is seeking a Senior/Principal Process Development Scientist - HPAPIs to lead development and optimization of robust scalable processes for HPAPI payloads and ADC-related intermediates. The role emphasizes safe handling, containment, and technology transfer to manufacturing, with client-facing accountability.

The candidate will design multi-step routes from starting materials, perform DOE, and supervise lab-to-plant scale-up while ensuring regulatory and company

Qualifications

• Bachelor's degree in Chemistry or related field with 15+ years' experience OR Master's with 9+ years OR PhD with 5+ years
• Experience in HPAPI and payload-linker development, containment strategies, and safe practices
• CDMO or fast-paced development experience preferred

Responsibilities

• Design and execute HPAPI process development from gram to multi-kg scale
• Perform DOE and impurity fate studies to control critical parameters
• Provide on-site support for scale-up and manufacturing transfer
• Lead technical reviews with clients and coordinate lab to plant transfer
• Mentor junior scientists and ensure compliance with cGMP and safety requirements

Skills

DOE design of experiments

Synthesis scale-up

HPAPI handling

Containment strategies

Process development

Cross-functional 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

GC

NMR

LC-MS

KF

Preparative chromatography

Job description

Sterling Pharma Solutions is seeking a Senior/Principal Process Development Scientist - HPAPIs to lead development and optimization of robust scalable processes for HPAPI payloads and ADC-related intermediates. The role emphasizes safe handling, containment, and technology transfer to manufacturing, with client-facing accountability.

The candidate will design multi-step routes from starting materials, perform DOE, and supervise lab-to-plant scale-up while ensuring regulatory and company