Senior / Principal Scientist, Formulation and Drug Product Development

The role

The Senior / Principal Scientist will lead formulation and drug product development for the ADC pipeline. This role focuses on late-stage development, regulatory submissions, and product lifecycle management for liquid and lyophilized biologics and ADCs.

What you will do

• Lead formulation development for antibody, drug substance, and ADC drug products.
• Serve as SME for formulation and drug product process development.
• Lead formulation and drug product comparability strategies and assessments.
• Establish and justify normal operating ranges, proven acceptable ranges, and control strategies.
• Collaborate with Drug Substance Development, Analytical Development, Manufacturing, Quality, Regulatory, and Clinical teams.
• Author and review technical reports and regulatory submission sections like IND, IMPD, BLA, and sBLA.
• Support regulatory interactions related to formulation and process development.
• Provide strategic leadership for product lifecycle management initiatives.
• Evaluate and implement emerging technologies in formulation and manufacturing.
• Mentor and develop junior scientists.

Required qualifications

• Bachelors, Masters, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Master’s, or 10 years with a Bachelor’s degree, or equivalent experience.
• Extensive experience in biologics and/or ADC drug product development, including lyophilized dosage forms.
• Demonstrated success leading late-stage development programs through Phase 3, regulatory submission, approval, and/or commercialization.
• Proven experience in formulation optimization, process characterization, comparability assessments, and drug product process development.
• Extensive experience establishing NORs, PARs, design spaces, and control strategies to support process validation and commercial manufacturing.
• Hands-on expertise in lyophilization cycle development, characterization, scale-up, validation support, and technology transfer for biologics.
• Experience leading comparability assessments associated with process changes, formulation changes, manufacturing site transfers, scale-up, and lifecycle management activities.
• Strong understanding of sterile drug product manufacturing, fill-finish operations, process validation, and commercial manufacturing requirements.
• Demonstrated experience authoring and reviewing CMC documentation for INDs, IMPDs, BLAs, sBLAs, and other global regulatory submissions.
• Experience working effectively with CDMOs and managing external development and manufacturing activities.

Benefits

• Medical, dental, and vision insurance coverage for employees and dependents
• 100% company-paid medical premiums for employees
• 401(k) with employer match
• Employer-paid life insurance, short- and long-term disability insurance, and AD&D
• Paid time off
• Company holidays
• A week-long winter break between Christmas and New Years
• Paid parental leave

About the company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. The company is advancing an innovative portfolio of therapeutics, including antibody-drug conjugates.