PositionSummary:ย
Reporting to the Sr Directorย Pharmaceuticalย Development, theย Associate Director or Director of Pharmaceutical Development will be a liaison for the manufacture ofย Erasca'sย small molecule development drug products (DPs) at external contract development and manufacturing organizations (CDMOs). This individual will work on cross functional teams with colleagues from process development, analytical, formulation development, supply chain, QA, and regulatory CMC to plan, coordinate, and execute internal and external DP development and manufacturing activities.ย
Essential Duties and Responsibilities:ย ย
- Provide scientific, technical, and strategic direction to the design, development, and manufacture of investigational drug products from pre-clinical/clinical to commercial stage.ย
- Manage activities and contractualย relationshipย with contract manufacturers and laboratories performing product/formulation development, manufacturing, analytical development and testing, stability, and validation services.ย
- Lead and collaborate with cross functional project team members to meet CMC goals.ย
- Represent CMC DP and provide strategic recommendations and status reporting to cross-functional program team.ย
- Author, review, and/or approve development reports, regulatory submissions (e.g., IND, IMPD, NDA, MAA), and SOPs.ย
- Act as Subject Matter Expert for knowledge of GMP regulations, ICH guidance, and current regulatory expectationsย regardingย DP manufacture and process control.ย
- Function as a highly effective communicator and team player in a dynamic team culture.ย
- Up to 25% travel will be neededย toย overseeย development and manufacturingย activitiesย as person-in-plantย ย
- Perform all duties in keeping with the Company's core values,ย policiesย and all applicable regulations.ย
Required Education, Experienceย and Attributes:ย ย
- Advanced degree in Pharmaceutics, Chemistry or related fieldย isย highly preferred, equivalent work experience and scientific credibility may be considered.ย
- 10ย to 12+ years of progressive experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing,ย experience inย enabling technologies and solid oral dosage formย manufacturing preferred.ย
- Experienceย managing relationships withย contract manufacturing organizationsย including knowledge of small molecule drug product validation and experience with regulatory submissions.ย
- Familiarity with ICH guidelines and regulatory expectations relevant to drug development andย cGMPsย including regulations in multiple countries.ย
- A strongย track recordย of scientific achievement.ย
- Demonstrated ability to influence without direct control.ย
- Ability to build strong relationships with co-workers of various backgrounds andย expertise.ย
- Ability to function atย a high levelย in a team setting whether asย manager,ย lead scientist,ย or individualย contributor.ย
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.ย
- Effective interpersonal and communication skills; a collaborative team player with a can-do attitude and the ability toย identifyย and implement creative solutions to complex technical problems.ย
- Strong learning orientation, curiosity, andย commitment toย science and patients.ย
The anticipated salary range for this position is $200,000 to $225,000.ย The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.ย ย