Director, CMC Formulations — Strategy & CDMO Leadership

Visa Hunt; United States; On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Discretionary bonuses

Comprehensive benefits package

Employer sponsored insurance (medical,

Generous paid time off

Retirement plan options

Job summary

Codera, a Tang Capital company, seeks a Director of CMC - Formulations to oversee strategy for drug product formulations across development programs. You will work with nonclinical, clinical pharmacology and regulatory teams to design formulations, oversee vendors and prepare regulatory documents.

You will lead CMC discussions, manage CDMO relationships, and contribute to regulatory submissions while advancing a fast-paced, data-driven scientific culture.

Qualifications

• Bachelor’s degree or higher in life sciences or related discipline required.
• Experience with small molecule formulations required; biologics formulations preferred.
• Minimum of 5 years in relevant pharmaceutical industry work experience required.
• Experience with CDMOs and analytical labs
• Experience with IND/NDA regulatory documentation writing or reviewing

Responsibilities

• Assist design and evaluation of drug product formulations to achieve PK goals.
• Contribute to CMC and development strategy.
• Manage relationships with CDMOs, analytical labs and CROs.
• Assist with clinical supply logistics.
• Prepare and interpret analytical data for regulatory/IP documents.
• Draft, edit and review regulatory and IP sections.
• Provide scientific input for analytical protocols and study reports.
• Contribute to a fast-paced data-driven culture.
• Research CMC topics to support Tang Capital’s investments.
• Participate in business development activities as requested.

Skills

Regulatory writing

Project management

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in life sciences

Master's degree

Job description

Codera, a Tang Capital company, seeks a Director of CMC - Formulations to oversee strategy for drug product formulations across development programs. You will work with nonclinical, clinical pharmacology and regulatory teams to design formulations, oversee vendors and prepare regulatory documents.

You will lead CMC discussions, manage CDMO relationships, and contribute to regulatory submissions while advancing a fast-paced, data-driven scientific culture.