Associate Director, Analytical Development
Olema Oncology
1 month ago
On-site
Cambridge, MA
Operations
Associate Director, Analytical Development
Responsibilities:
- 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 analysis from CDMOs for batch release and stability testing of drug substances and drug products
- Work on stability programs, monitor/trend stability data, and establish retest periods or shelf lives for drug substances or drug products
- Provide technical input and resolve analytical/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
Qualifications:
- MS or PhD in Chemistry or equivalent scientific discipline
- Expertise in analytical development and quality control for drug substances (emphasis) and drug product
- Knowledge of cGMP, ICH, and FDA regulations/guidance
Experience:
- Minimum of 7+ 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
- Experience driving CDMO capabilities to meet milestones for multiple projects while maintaining internal technical expertise
- Experience partnering with cross-functional teams and providing analytical development leadership
- Effective written/oral communication and interpersonal skills
Skills/Attributes:
- Analytical thinking and strong problem-solving; ability to adapt to changing priorities and deadlines
- Self-motivated, enthusiastic fast learner
- Teamwork and collaboration; gives/welcomes feedback
- Aspires to the highest scientific and ethical standards
- Keen to improve processes and overcome inefficiencies
Travel/Location:
- Based in San Francisco, CA or Boston, MA; requires 10–15% travel
Compensation/Benefits:
- Base pay range: $190,000–$205,000 annually (varies by location/experience); total compensation includes equity, bonus, and benefits
Application instructions:
- Olema does not accept agency resumes; not responsible for fees related to unsolicited resumes
Responsibilities:
- 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 analysis from CDMOs for batch release and stability testing of drug substances and drug products
- Work on stability programs, monitor/trend stability data, and establish retest periods or shelf lives for drug substances or drug products
- Provide technical input and resolve analytical/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
Qualifications:
- MS or PhD in Chemistry or equivalent scientific discipline
- Expertise in analytical development and quality control for drug substances (emphasis) and drug product
- Knowledge of cGMP, ICH, and FDA regulations/guidance
Experience:
- Minimum of 7+ 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
- Experience driving CDMO capabilities to meet milestones for multiple projects while maintaining internal technical expertise
- Experience partnering with cross-functional teams and providing analytical development leadership
- Effective written/oral communication and interpersonal skills
Skills/Attributes:
- Analytical thinking and strong problem-solving; ability to adapt to changing priorities and deadlines
- Self-motivated, enthusiastic fast learner
- Teamwork and collaboration; gives/welcomes feedback
- Aspires to the highest scientific and ethical standards
- Keen to improve processes and overcome inefficiencies
Travel/Location:
- Based in San Francisco, CA or Boston, MA; requires 10–15% travel
Compensation/Benefits:
- Base pay range: $190,000–$205,000 annually (varies by location/experience); total compensation includes equity, bonus, and benefits
Application instructions:
- Olema does not accept agency resumes; not responsible for fees related to unsolicited resumes