Associate Director, CMC Statistics

Associate Director, CMC Statistics

The Associate Director, CMC Statistics, will provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls (CMC) activities. This individual will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to develop scientifically sound, phase-appropriate, and regulatory-defensible statistical strategies for drug substance and drug product development. The role will be accountable for statistical support of specification setting, stability trending and shelf-life assessment, analytical method bridging and transfer, comparability assessments, method validation, process and product monitoring, investigations, and lifecycle management. The successful candidate will translate complex CMC datasets into clear conclusions, risk assessments, and recommendations that support global regulatory submissions, commercial readiness, and ongoing product control.

The position is based onsite in Summit's Princeton, New Jersey office and requires in-office presence four days per week. Periodic travel may be required to support CDMO/CRO oversight, technical meetings, audits, inspections, regulatory interactions, or cross-functional workshops.

The pay range for this role will vary depending on location. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.

Summit is an equal opportunity employer committed to fostering an inclusive workplace. Employment decisions are made without regard to any status protected by applicable law.

Pay Transparency $180,000 $200,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.