Director, CMC Formulations & Strategy

Codera; San Diego (CA); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Employer sponsored insurance plans (medical, dental, vision)

Generous paid time off

Retirement plan options

Wellness and professional development programs

Job summary

Codera is seeking a Director, CMC - Formulations in San Diego, California, to oversee CMC strategy and contribute to drug product formulations. The ideal candidate will have a minimum of 5 years in pharmaceutical industry experience, a Bachelor’s or higher in life sciences, and experience with small molecule formulations. Responsibilities include managing relationships with CDMOs, preparing analytical data, and drafting regulatory documents. This position offers a salary of $190,000 - $260,000, along with comprehensive benefits.

Qualifications

• Minimum of 5 years in relevant pharmaceutical industry work experience required.
• Experience writing and reviewing regulatory documents including IND/NDA sections.
• Experience with formulates for oral, subcutaneous, or inhaled delivery.

Responsibilities

• Assist with designing drug product formulations to achieve PK goals.
• Manage relationships with CDMOs, analytical labs, and CROs.
• Prepare and analyze analytical data for regulatory documents.

Skills

Experience with small molecule formulations

Excellent knowledge of FDA and ICH regulations

Outstanding written and verbal communication

Ability to manage multiple assignments

Ability to establish collaborative relationships

Education

Bachelor’s degree in life sciences or related discipline

Master’s degree preferred

Job description

Codera is seeking a Director, CMC - Formulations in San Diego, California, to oversee CMC strategy and contribute to drug product formulations. The ideal candidate will have a minimum of 5 years in pharmaceutical industry experience, a Bachelor’s or higher in life sciences, and experience with small molecule formulations. Responsibilities include managing relationships with CDMOs, preparing analytical data, and drafting regulatory documents. This position offers a salary of $190,000 - $260,000, along with comprehensive benefits.