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, Analytical Chemistry
We are seeking an experienced, driven colleague to lead our analytical development and quality control efforts. This role will
report to the Senior Director, Analytical Chemistry
and will be responsible for driving progress of both early-stage and late-stage molecules by delivering phase-appropriate analytical methods and validation and working closely with cross functional teams.This position is available in either our San Francisco or Boston office with minimal travel.
Your work will primarily encompass:
- Support analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
- Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
- Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
- Work on stability programs, monitoring/trending stability data and establish retest periods or shelf lives for drug substances or drug products
- Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
- Support regulatory filings (IND, IMPD, NDA, MAA) submissions as needed
- Represent Analytical Chemistry at internal and external scientific team meetings as needed
- Stay current with state-of-the art approaches and applicable global regulations and industry standards
Ideal Candidate Profile
>>>
Key Requirements
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:
- BS degree in chemistry or equivalent scientific discipline with 10+ years of relevant industry experience
- MS in Chemistry or equivalent scientific discipline with 7+ years of relevant industry experience
- PhD in Chemistry or equivalent scientific discipline with 5+ years of relevant industry experience
Experience:
- Exposure to small molecule drug substance analytical development and quality control, including late-stage clinical development and preparation for product registration
- Expertise in analytical development and quality control for both drug substances and drug product
- Knowledge of cGMP, ICH, and FDA regulations/guidance
- Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects
Attributes:
- Able to be proactive and self-disciplined, you can meet deliverable timelines, and effectively use your time and prioritize
- Ability to build strong working relationships with internal teams and external vendors
- Ability to effectively communicate (verbal and written) analytical findings
- Excellent analytical, problem-solving, strategic planning, and interpersonal skills
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization
- Have impeccable professional ethics, integrity, and judgement
The base pay range for this position is expected to be $193,300 - $214,000 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-SB1
Important Information
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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.
