Associate Director, Protein Sciences & IND Readiness

EPM Scientific; Menlo Park (CA); On-site; USD 200,000 - 250,000; Full time

Job summary

EPM Scientific is seeking a senior scientific leader to drive antibody characterization, develop-ability assessments, and early CMC activities for a stealth-mode biotech. You will perform hands-on studies, manage CROs/CDMOs, and guide IND-enabling development to build a robust development program.

The role partners with the CSO, leads cross-functional teams, and may expand a team as the company grows; candidates should have extensive antibody/protein therapeutics experience and a track record in

Qualifications

• PhD preferred; MS/BS with relevant experience acceptable.
• 5+ years in senior roles; 8+ for associate director; 10+ for director in industry.
• Strong experience with therapeutic antibodies and protein biologics.
• Experience supporting IND-enabling development and early CMC activities.

Responsibilities

• Lead characterization and developability assessments of monoclonal and bispecific antibodies.
• Oversee protein expression/purification using mammalian systems.
• Coordinate analytical/biophysical studies (SEC-HPLC, CE-SDS, DLS, etc.).
• Assess aggregation, stability, charge variants, fragmentation, solubility, and CQAs.
• Design and execute formulation and forced degradation studies.
• Troubleshoot developability challenges including low expression and manufacturing liabilities.
• Integrate analytical data to support candidate selection.
• Manage CROs, CDMOs, and analytical partners with timelines and budgets.
• Support process development, tech transfer, and manufacturing readiness.
• Contribute to pre-IND and IND CMC strategy.
• Collaborate with teams in the U.S. and China.

Skills

Antibody characterization

Developability assessment

Protein sciences

IND/CMC experience

CRO/CDMO management

Education

PhD preferred in Protein Chemistry/Biochemistry/Biophysics/Pharmaceutical Sciences/Molecular Biology or related field

MS/BS with relevant experience

Job description

EPM Scientific is seeking a senior scientific leader to drive antibody characterization, develop-ability assessments, and early CMC activities for a stealth-mode biotech. You will perform hands-on studies, manage CROs/CDMOs, and guide IND-enabling development to build a robust development program.

The role partners with the CSO, leads cross-functional teams, and may expand a team as the company grows; candidates should have extensive antibody/protein therapeutics experience and a track record in