Erasca
Assoc Director/Director, Pharmaceutical Development
South San Francisco, CA · Director
Sponsorship not specifiedDetected 41 days ago
Supply ChainGMPCommunication
About the role
- Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.
- Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.
Responsibilities
- Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products from pre-clinical/clinical to commercial stage.
- Manage activities and contractual relationship with contract manufacturers and laboratories performing product/formulation development, manufacturing, analytical development and testing, stability, and validation services.
- Lead and collaborate with cross functional project team members to meet CMC goals.
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
Requirements
- Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectations regarding DP manufacture and process control.
Nice to have
- Advanced degree in Pharmaceutics, Chemistry or related field is highly preferred, equivalent work experience and scientific credibility may be considered.
- Experience managing relationships with contract manufacturing organizations including knowledge of small molecule drug product validation and experience with regulatory submissions.
- Familiarity with ICH guidelines and regulatory expectations relevant to drug development and cGMPs including regulations in multiple countries.
- A strong track record of scientific achievement.
- Demonstrated ability to influence without direct control.
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
- Effective interpersonal and communication skills
Compensation
- The anticipated salary range for this position is $200,000 to $225,000.
Benefits
- Required Education, Experience and Attributes:
Company info
- Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer.
- Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide.
- The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer.
This listing is sourced directly from Erasca's careers page and normalized into a canonical job model.