Director, CMC - Formulations

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

About Codera

Codera is a Tang Capital company that provides in-house, end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.

Position Summary

The Director, CMC - Formulations will contribute to the oversight, planning and execution of Chemistry, Manufacturing and Controls (CMC) strategy, including drug product formulations, in support of Codera’s development programs. In collaboration with internal departments, such as nonclinical, clinical pharmacology and regulatory teams, the Director, CMC - Formulations will contribute to all aspects of chemistry, manufacturing and controls, including design of drug product formulations, oversight of vendors and production of regulatory documents.

Essential Duties and Responsibilities

• Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals
• Contribute to CMC and development strategy
• Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs)
• Assist with the clinical supply logistics
• Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents
• Draft, edit and review sections of regulatory and IP documents
• Provide scientific input for analytical protocols and study reports
• Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence
• Research CMC and formulation topics to support Tang Capital’s investments
• Participate in business development activities, as requested

Qualifications

• Bachelor’s degree or higher in life sciences or related discipline required
• Master’s degree preferred
• Minimum of 5 years in relevant pharmaceutical industry work experience required
• Experience with small molecule formulations required
• Experience with biologics formulations preferred
• Experience working with CDMOs and analytical labs
• Experience with one or more of the following drug product formulation strategies: modified/delayed release, fixed-dose combinations, spray-dried dispersions
• Experience with a wide range of excipients and formulation technologies
• Experience with formulations for oral, subcutaneous and/or inhaled delivery
• Ability to research, synthesize and summarize complex CMC topics
• Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA) sections
• Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission
• Excellent knowledge of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and Good Manufacturing Practices (GMP)
• Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
• Ability to establish and maintain collaborative working relationships with internal and external stakeholders

The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.

The estimated annual base salary for this position is $190,000 - $260,000, commensurate with experience and skills. This role may be eligible for discretionary bonuses and other incentive programs.

Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and include employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs

Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Codera participate in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.

Salary: 190,000 - 260,000