Full-Time

Associate Director

Formulation

Updated on 5/15/2024

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulation therapies for diseases

Biotechnology

Senior

Menlo Park, CA, USA

Required Skills
Communications
Quality Assurance (QA)
Requirements
  • Technical expertise in solid oral dose formulations for small molecules
  • Hands-on experience in formulating drugs with limited solubility
  • Experience in formulation and process development from early to late phase development
  • Understanding of ICH, FDA, EMA guidance in CMC and Quality areas
  • Knowledge of GMP requirements for drug product development and manufacturing
  • Experience in writing CMC sections of regulatory filings
  • Strong written and oral communication skills
  • Project management and leadership skills
  • Ability to work in a fast-paced environment
Responsibilities
  • 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
  • Select and manage contract development and manufacturing vendors
  • Negotiate and approve statements of work and quotes
  • Review and approve manufacturing documents, protocols, and reports
  • Ensure drug product requirements for clinical trials are met
  • Work closely with QA to ensure clinical supplies meet quality requirements
  • Prepare CMC sections of regulatory filings

At Corcept Therapeutics, we specialize in pioneering selective glucocorticoid receptor antagonists. Our focused efforts extend to over 30 active studies aimed at addressing the detrimental impacts of excess cortisol in endocrine, metabolic, oncologic, and psychiatric conditions. We are dedicated not only to advancing medical science but also to prioritizing the well-being of our team, ensuring a collaborative and supportive work environment that fosters innovation and professional growth.

Company Stage

IPO

Total Funding

$119.1M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

12%

1 year growth

21%

2 year growth

45%