Who We Are >>> Why You Should Work With Us
Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.
Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer.
Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.
About the Role >>> Director, Chemistry Manufacturing & Controls (CMC) Drug Product Development
The individual in this role will be responsible for all aspects of small molecule drug product development, including drug product formulation and cGMP manufacturing, operations, oversight of laboratory development work and analytical testing at external research, development, and manufacturing organizations (CDMOs). We are looking for an independent, self-starter with experience designing and manufacturing solid oral dosage formulations under cGMP. In addition to review of manufacturing plans, including 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.
What You Will Do:
- Provide technical, functional, and project leadership on drug product development and CDMO management
- Work collaboratively with discovery chemistry, toxicology, pharmacology, quality assurance, CMC regulatory, supply chain, and clinical development to develop and deliver drug products 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 products at CDMOs
- Author and review technical documents, formulation development reports, and drug product sections for IND, IMPD and global marketing applications
- Ph.D. in chemistry, pharmaceutical sciences, or related discipline with 10+ years of experience, or Master with 12 - 15 years of experience, in a CMC development organization
- 5+ years managing managing a CDMO
- 1-2 years of people management experience
- Excellent scientific knowledge in pre-formulation and formulation
- A track record of successful development of solid oral dosage forms and enabled formulations is highly desired
- Knowledge of good manufacturing practices for the preparation of drug products for clinical studies
- 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
- Experience in drafting drug product sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
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
- Goal 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
- Ability to development strong relationships
The base pay range for this position is expected to be $215,000 - $245,000 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.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.