Director, CMC Drug Substance Development

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 >>> Director, CMC Drug Substance Development

As the Director of CMC Drug Substance Development reporting to the Senior Director of CMC Drug Substance Development, you will be responsible for drug substance process development and cGMP manufacturing at external contract manufacturing and development organizations (CDMOs). We are looking for an independent, experienced process chemist with a track record of successful oversight of manufacturing of small molecule drug substances under cGMP. In addition to leading process development activities and managing manufacturing campaigns, including reviews of master and executed batch records, this individual will be responsible for the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions including INDs, IMPDs, NDAs, etc.

This role is based out of our San Francisco, CA or Cambridge, MA office and will require up to 10% travel.

Your work will primarily encompass:

• Provide technical, functional, and project leadership on drug substance development, manufacturing, and CDMO management.
• Work collaboratively with discovery chemistry, toxicology, pharmacology, quality assurance, CMC regulatory, supply chain, and clinical development to develop and deliver drug substances for all phases of preclinical and clinical development.
• Collaborate with SMEs in the CMC department on the development and validation of analytical test methods for drug substances at CDMOs.
• Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications.
• Develop in-process control strategies, normal operating and proven acceptable ranges, starting material, intermediate and drug substance specifications based on sound scientific and regulatory principles.
• Staying current with state-of-the art approaches and applicable global regulations and industry standards.
  
  

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:

• Ph.D. in Organic Chemistry, or related discipline with 10 years of experience, or Masters with 12-15 years of experience, in a CMC development organization.
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role.
• Expertise in small molecule process development and oversight of GMP manufacturing, including process validation.
• Experience authoring and reviewing technical documents including, but not limited to development reports, master batch records, analytical testing methods, and specifications.
• Knowledge of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance and drug products.
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency reviews.
• Effective written, oral communication and interpersonal skills.
  
  

Attributes:

• A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally.
• Strong initiative and follow-through are essential for this job.
• Specific personal characteristics include:
• Highly analytical and detail oriented
• Self-Starter
• Goal and data driven
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Aspires to the highest of scientific and ethical standards
• Keen to improve processes and overcome inefficiencies
  

The base pay range for this position is expected to be $ 207,000 - $ 215,000 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.

Important Information >>>

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.

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.