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Director/Sr. Director, Late Stage CMC Drug Substance Development

Employer
Olema Oncology
Location
San Francisco, California
Start date
Dec 5, 2023

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Discipline
Science/R&D, Pharmacology, CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Who We Are >>> Why You Should Work With Us

Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated both as a single agent in an ongoing Phase 2 clinical trial, and in combination with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Palazestrant has been granted FDA Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com, or follow us on Twitter and LinkedIn.

Onto something big, 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. 

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, Late Stage CMC Drug Substance Development

As the Director of Late Stage CMC Drug Substance Development reporting to the Vice-President of CMC, you will have direct ownership and oversight of all aspects of small molecule drug substance development at Olema. 

This will include process development and cGMP manufacturing; operations; and oversight of laboratory development work and analytical testing at external research, development, and manufacturing organizations (CDMOs). In addition to reviewing manufacturing plans (including master and executed batch records), you will also be responsible for the preparation and review of technical development reports and authoring of the CMC sections of regulatory submissions (INDs, IMPDs, NDAs, etc.).

This hands-on role requires an independent self-starer with experience developing process and manufacturing small molecule drug substance under cGMP. The role will be based out of our San Francisco office and require occasional travel.

You will primarily:

  • Provide technical, functional, and project leadership on drug substance development, manufacturing, and CDMO management
  • Develop and deliver drug substances for all phases of preclinical and clinical development, working collaboratively with Discovery Chemistry, Toxicology, Pharmacology, Quality Assurance, CMC Regulatory, Supply Chain, and Clinical Development departments
  • 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, and intermediate and drug substance specifications based on sound scientific and regulatory principles
  • Stay current with state-of-the art approaches and applicable global regulations and industry standards

Ideal Candidate Profile >>> Independent Self-Starter with Experience in Late Stage Small Molecule Drug Substance under cGMP

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 in a CMC development organization
  • Expertise in small molecule process development and manufacturing for a Phase III asset(s) required
  • Demonstrated success in using GMP for the preparation of drug substance for clinical studies
  • Broad understanding of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance product
  • Demonstrated success in drafting drug substance sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review

Attributes:

  • Demonstrated track-record of leadership and success
  • Strong decision making skills
  • High level of curiosity and intelligence; highly analytical
  • Self-starter with great initiative who’s able to work independently and deliver on follow-through
  • Positive can-do attitude
  • Good communication and interpersonal skills; able to work cross-functionally
  • Driven to meet goals 
  • Able to multi-task and shift priorities rapidly to meet tight deadlines
  • Aspires to the highest level of scientific and ethical standards
  • Keen to improve processes and overcome inefficiencies

The base pay range for this position is expected to be $215,000 - $240,000 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.

#LI-MK1

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.

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.

Company

We exist to develop therapies that offer the potential to improve outcomes for women living with cancer. We approach these goals with a single-minded focus.

At Olema Oncology, we leverage our deep understanding of endocrine-driven cancers, nuclear receptors and mechanisms of acquired resistance with the goal of transforming the standard of care for women living with cancer by focusing on developing more convenient and effective therapies. Join us as we aim to design therapies for improving lives.

Why Join Us?

We 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 provide equal opportunity to all employees and applicants for employment and offer competitive compensation and benefits.

Olema seeks to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers.

Located in Cambridge, MA and San Francisco, CA

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Company info
Website
Location
780 Brannan Street
San Francisco
California
94103
United States

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