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, Formulation Development
As the Associate Director, Formulation Development reporting to the Sr. Director of CMC Drug Product Development, you will lead pre-formulation, formulation development, tech transfer, scale up & manufacturing, and support registration, design of experiments, scale up, process performance qualification & commercialization. This role provides scientific expertise in solid oral dosage formulation development, early to late-stage process development, oversight of GMP drug product manufacturing at contract development sites, authoring global regulatory filings (INDs, IMPDs, NDA, MAA, etc.) and technical oversight of preclinical and clinical formulation development effort.
This position will collaborate with cross functional departments and other CMC functions in a fast-paced, high growth environment to ensure progression of Olema small molecules from discovery through development/commercialization.This role is based out of our San Francisco office and will require 10-25%
travel (domestic and international).Your work will primarily encompass:
- Leading preclinical and early clinical phase formulation development efforts at CMO and providing oversight of tech transfer to GMP vendor for clinical scale up and GMP drug product manufacturing
- Designing and providing oversight for development and characterization studies in evaluating formulation development and drug product unit process feasibility
- Working closely with CMOs to address and refine formulation and process related challenges over the entire course of clinical drug product development
- Developing strategies and execution plans for drug product development from first human dosage through development of late phase ready formulations in accordance with timelines and requirements of overall development programs
- Working closely with the clinical supply team to ensure uninterrupted drug product supply for ongoing studies and strategically risk-mitigate any supply constraint
- Working closely with project management to align on study timeline and corresponding drug product supply plan to adequately secure MP production slots at CDMOs
- Working closely with project management to identify critical CMC decision points, gain alignment at Program Team (PT) level and final endorsement from Executive Commitment (EC)
- Working closely with Olema's regulatory CMC team (and/or consultants) to align on filing strategies, including clearing regulatory responsibilities to provide drug product for studies
- Identifying high quality drug product manufacture CMOs or CDMOs in expertise, capability and capacity for effective collaboration in developing and/or commercializing Olema molecule
- Leading formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at CDMOs
- Reviewing and approving manufacturing documents, protocols and reports
- Supporting manufacturing and quality function to solve technical issues and address deviation investigations
- Writing technical reports and authoring CMC sections of regulatory submissions related to drug product from IND through NDA stage of 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:
- Ph.D. / M.S in Pharmaceutical Science, Chemical Engineering or related field
- Demonstrated experience in late-stage oral solid dose development and manufacturing preferred
Experience:
- 8+ years' experience in pre-formulation, formulation development for small molecules with 5+ years managing outsourced development activities
- Experience in formulation and process development; early stage preferably with direct experience with late-stage oral solid dose manufacturing process
- Experience in leading formulation projects in pre-formulation, formulation development, process selection and scale up, and oversight of GMP manufacture
- Good working knowledge of GMP requirements for drug product development and manufacturing
- Solid understanding of ICH, FDA, EMA guidance in CMC and Quality areas
- Effective written, oral communication and interpersonal skills
Attributes:
- Self-motivated, organized, detail-oriented, team-oriented, a critical thinker and an out-of-the-box problem-solver
- Proactive, strategic and skillful at multi-tasking
- Excels in team settings with the added ability to work independently
The base pay range for this position is expected to be
$183,000 - $191,00annually, 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.
#LI-MT1
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.
