Olema Oncology · 18 hours ago
Director, Analytical Development
Cambridge, MA
Full-time
Hybrid
Director/Executive
$215K/yr - $230K/yr
10+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Director of Analytical Development, you will be responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation, ensuring alignment with regulatory expectations, and partnering cross-functionally to support various activities.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Hiring Manager
Maribel Teixeira
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
Qualification
Required
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 on managing internal and external teams
Expertise of 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
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 role
Aspires to the highest of scientific and ethical standards
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Keen to improve processes and overcome inefficiencies
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase