Associate Director - Formulation Development

Associate Director of Formulation Development - Permanent - Menlo Park CA

Proclinical is seeking a dedicated and innovative individual for the role of Associate Director, Formulation.

Primary Responsibilities:

The successful candidate will play a crucial role in supporting drug product development and manufacturing of solid oral dosage forms at contract development sites. This role is an exciting opportunity to contribute to the advancement of cortisol modulation treatments for serious diseases.

Skills & Requirements:

• Expertise in solid oral dose formulations for small molecules.
• Hands-on experience in formulating drugs with limited solubility and knowledge about technologies employed to enhance bioavailability.
• Experience in formulation and process development from early to late phase development.
• Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas.
• Good working knowledge of GMP requirements for drug product development and manufacturing.
• Experience in writing CMC sections of regulatory filings.
• Strong written and oral communication skills.
• Good project management and leadership skills, with the ability to lead multiple programs simultaneously.
• Ability to thrive in a fast-paced environment within a matrix organization.

The Associate Director of Formulation Development's responsibilities will be:

• Design and select appropriate formulations for toxicology and first in human studies.
• Support formulation and process development, technology transfer, and clinical manufacturing activities.
• Develop strategies and execute plans for drug product development in line with overall development programs.
• Select and manage contract development and manufacturing vendors.
• Negotiate and approve statements of work and quotes.
• Review and approve manufacturing documents, protocols, and reports.
• Collaborate with internal functional groups to ensure all drug product requirements for clinical trials are met.
• Work closely with Quality Assurance to ensure clinical supplies meet quality requirements.
• Prepare CMC sections of regulatory filings.
• Travel as required (15-20%).

If you are having difficulty in applying or if you have any questions, please contact Alex Bero at a.bero@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDOA