Olema Oncology
About the Role
Director, Analytical Development reporting to the Senior Director, Analytical Chemistry, you will be responsible for driving progress of both early and late‑stage molecules by delivering phase‑appropriate analytical methods and validation. You will drive method innovation, ensure alignment with regulatory expectations, and partner cross‑functionally to support process development, formulation, CMC, and quality activities. This role is based out of either our San Francisco or Boston offices and will require 10% travel.
Responsibilities
Oversee 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.
Manage stability programs, monitor 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.
Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions.
Represent Analytical Chemistry at internal and external scientific team meetings as needed.
Remain current with state‑of‑the‑art approaches and applicable global regulations and industry standards.
Ideal Candidate Profile Knowledge and Experience
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small‑molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration.
Minimum of 5 years direct leadership experience managing internal and external teams.
Expertise in cGMP, ICH, and FDA regulations/guidance.
Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND, IMPD, information requests, amendments, briefing books, NDA, MAA, etc.).
Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones.
Experience in partnering with cross‑functional teams providing analytical development leadership across programs and projects.
Demonstrated interpersonal skills, including strong oral and written communication abilities.
Attributes
A high level of curiosity, intelligence, ability to work independently, a "can do" attitude, and ability to work cross‑functionally. Strong initiative and follow‑through are essential.
Aspires to the highest scientific and ethical standards.
Ability to multi‑task and shift priorities rapidly to meet tight deadlines.
Keen to improve processes and overcome inefficiencies.
Compensation The base pay range for this position is expected to be
$215,000 – $230,000
annually, although it may vary depending on location, market, relevant knowledge, skills and experience. The total compensation package also includes equity, bonus, and benefits. A summary of benefits is available for all applicants.
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.
Fraud Alert We are aware of employment scams where individuals pose as representatives of Olema Oncology and use our company name to defraud job seekers. Official Olema email addresses end in @olema.com. Our official website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is linked. Please visit those sites for official information. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments, or make job offers without an in‑person interview.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
#J-18808-Ljbffr
Responsibilities
Oversee 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.
Manage stability programs, monitor 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.
Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions.
Represent Analytical Chemistry at internal and external scientific team meetings as needed.
Remain current with state‑of‑the‑art approaches and applicable global regulations and industry standards.
Ideal Candidate Profile Knowledge and Experience
PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small‑molecule drug substance and drug product analytical development and quality control, including late‑stage clinical development and preparation for product registration.
Minimum of 5 years direct leadership experience managing internal and external teams.
Expertise in cGMP, ICH, and FDA regulations/guidance.
Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND, IMPD, information requests, amendments, briefing books, NDA, MAA, etc.).
Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones.
Experience in partnering with cross‑functional teams providing analytical development leadership across programs and projects.
Demonstrated interpersonal skills, including strong oral and written communication abilities.
Attributes
A high level of curiosity, intelligence, ability to work independently, a "can do" attitude, and ability to work cross‑functionally. Strong initiative and follow‑through are essential.
Aspires to the highest scientific and ethical standards.
Ability to multi‑task and shift priorities rapidly to meet tight deadlines.
Keen to improve processes and overcome inefficiencies.
Compensation The base pay range for this position is expected to be
$215,000 – $230,000
annually, although it may vary depending on location, market, relevant knowledge, skills and experience. The total compensation package also includes equity, bonus, and benefits. A summary of benefits is available for all applicants.
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.
Fraud Alert We are aware of employment scams where individuals pose as representatives of Olema Oncology and use our company name to defraud job seekers. Official Olema email addresses end in @olema.com. Our official website is
olema.com ; our careers page is
olema.com/careers ; our LinkedIn page is linked. Please visit those sites for official information. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments, or make job offers without an in‑person interview.
Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
#J-18808-Ljbffr