Associate Director, CMC Drug Substance Development and Manufacturing

About Olema Oncology

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

Associate Director, CMC Drug Substance Development and Manufacturing

As the Associate Director, CMC Drug Substance Development and Manufacturing reporting to the Senior Director of CMC Drug Substance you will support drug substance process development and cGMP manufacturing activities at external contract manufacturing and development organizations (CDMOs). We are looking for an experienced process chemist with a track record of successful oversight of manufacturing small molecule drug substances under cGMP. In addition to supporting process development activities and managing manufacturing campaigns, including reviews of master and executed batch records, this individual will contribute to 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 or Boston office and will require up to 10% travel.

Your work will primarily encompass:

• Provide technical guidance and lead drug substance process development, manufacturing and CDMO management
• Lead technical meetings with CDMOs and provide status updates to internal teams
• Represent drug substance function on cross-functional CMC and project teams, providing technical and strategic input
• Review manufacturing documentation to enable GMP drug substance production and clinical supply
• Collaborate with QA/QC to identify and evaluate deviations, CAPAs and change controls
• 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
• Stay current with emerging technologies, regulatory trends, and industry best practices in drug substance development

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:

• M.Sc. or Ph.D. in Organic Chemistry, or related discipline with 8+ years of experience in a CMC development organization
• Expertise in small molecule process development and GMP manufacturing, preferably across all phases of development (pre-IND to commercial manufacturing)
• Knowledge of good manufacturing practices for the preparation of drug substance for clinical studies
• Knowledge of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
• Experience authoring and reviewing technical documents including, but not limited to development reports, master batch records, analytical testing methods, and specifications
• Effective written, oral communication and interpersonal skills
• Power-user of Microsoft Office Suite, Chemdraw, Scifinder, etc.

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
• Highly analytical and detail oriented
• Strong data and document organization skills
• 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

Compensation

The base pay range for this position is expected to be $175,000 - $185,000 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.