Olema Oncology · 3 weeks ago
Senior Director, CMC Drug Substance Development & Manufacturing
San Francisco, California
Full-time
Onsite
Director/Executive
$270K/yr - $290K/yr
12+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. The Senior Director of CMC Drug Substance Development & Manufacturing will lead technical project management and oversee manufacturing activities for small molecule drug substances, ensuring compliance with quality standards and regulatory requirements.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Provide technical and functional project leadership on drug substance process development, manufacturing, and CMO management
Create and disseminate technical transfer information and documentation required for familiarization, transfer, validation and routine manufacturing
Collaborate with SMEs within the CMC department on the development and validation of analytical test methods for drug substances
Lead or support documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition
Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations
Partner with Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate CMC procedures to ensure the drug substance meets established quality standards and adheres to established and regulatory agency approved parameters
Work closely with SMEs to execute shipment of drug substance batches
Partner with supply chain teams to design API production schedules while maximizing production and cost efficiencies
Author and review technical documents, process development reports, and drug substance sections for IND, IMPD and global marketing applications
Stay current with state-of-the art approaches and applicable global regulations and industry standards
Qualification
Required
Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience, in a CMC development organization
A minimum of 5+ years of direct people management and leadership experience
Demonstrated successful leadership in a pharmaceutical CMC drug substance development role
Broad experience working with CDMOs and managing external development and manufacturing partners
Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation
Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations
Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications
Thorough understanding of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substances
Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews
Effective written, oral communication and interpersonal skills
Publications in peer reviewed journals and patent applications record
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
Demonstrated ability to collaborate effectively within cross-functional teams
Highly analytical and detail oriented
Self-Starter
Goal and data driven
Ability to multi-task and shift priorities rapidly to meet tight deadlines
Aspires to the highest scientific and ethical standards
Motivated to improve processes and overcome inefficiencies
Benefits
Equity
Bonus
Benefits
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