What are the responsibilities and job description for the Vice President, Chemistry, Manufacturing, and Controls (CMC) position at Tbwa Chiat/Day Inc?
Vice President, Chemistry, Manufacturing, and Controls (CMC)
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role :
Reporting to the Chief Discovery and Nonclinical Development Officer, the Vice President of Chemistry, Manufacturing and Control (CMC) will lead a growing team of highly skilled professionals across multiple disciplines responsible for small molecule drug substance and drug product process development and manufacturing activities for all phases across Olema’s portfolio. This work is carried out by outsourcing to various contract development & manufacturing organizations (CDMO). The candidate will serve as the primary liaison with drug substance, drug product, analytical and other functional areas to ensure that high quality standards are maintained and appropriate documentation (development reports, batch records, regulatory filings, etc.) are completed in an effective and timely manner. In addition to having advanced skills in organic chemistry related to scale up and manufacturing, the ideal candidate is expected to have exceptional leadership, organizational, collaboration, and communication skills.
The role of Vice President, CMC at Olema represents a fantastic opportunity for a motivated, hands-on CMC professional to join a cutting-edge leadership team to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.
This role is based out of our San Francisco, CA office.
What You Will Do :
- Lead a multifunctional team of CMC professionals to supply clinical trial material for Olema’s multiple development programs, and prepare those programs for commercialization.
- Serve as the primary point of contact and source of information regarding CMC activities for Olema’s executive team (periodically including Olema’s Board of Directors) by routinely presenting clear and concise guidance for key decision making.
- Develop overall small molecule drug substance and drug product manufacturing strategy, timelines, and risk mitigation for all process development and manufacturing campaigns for early development through NDA.
- Guide the development of in-process control strategies, normal operating and proven acceptable ranges, starting material, intermediate and drug substance specifications based on sound scientific and regulatory principles.
- Lead problem solving and risk mitigation across the CMC effort, including identifying sources for starting materials and intermediates, developing plans for consistent and continuous supply, identifying process impurities and steps for their control, and working with CDMO on synthesis or isolation of process impurities.
- Lead combined team of internal technical subject matter experts (SME) and CDMOs through technology transfers, scale-up, validation, and problem-solving activities during all stages of manufacturing.
- Evaluate and select appropriate CDMOs for project specific development activities, as needed.
- In partnership with Regulatory, author appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions.
- Direct and approve batch records for drug substance and drug product manufacturing, process development reports and IP applications.
Ideal Candidate Profile :
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge and Experience :
Attributes :
The base pay range for this position is expected to be $330,000 - $360,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package , seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
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Salary : $330,000 - $360,000
