Associate Director, Analytical Development
Olema Oncology
1 month ago
On-site
Boston, 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 analyses 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
- Provide technical input and resolve analytical and quality control issues, deviations, and OOS/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, global regulations, and industry standards
Qualifications / Required:
- 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
- Minimum 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)
Preferred / Skills:
- Experience driving CDMO capabilities to meet milestones for multiple projects while maintaining in-house technical expertise
- Experience partnering with cross-functional teams; analytical development leadership across programs/projects
- Effective written, oral communication, and interpersonal skills
- Analytical thinking, problem-solving, and ability to adapt to changing priorities and deadlines
- Teamwork and collaboration
- Commitment to high scientific and ethical standards
- Process improvement mindset; ability to overcome inefficiencies
Compensation / Benefits:
- Base pay range: $190,000–$205,000 annually (varies by location/market/skills/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 analyses 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
- Provide technical input and resolve analytical and quality control issues, deviations, and OOS/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, global regulations, and industry standards
Qualifications / Required:
- 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
- Minimum 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)
Preferred / Skills:
- Experience driving CDMO capabilities to meet milestones for multiple projects while maintaining in-house technical expertise
- Experience partnering with cross-functional teams; analytical development leadership across programs/projects
- Effective written, oral communication, and interpersonal skills
- Analytical thinking, problem-solving, and ability to adapt to changing priorities and deadlines
- Teamwork and collaboration
- Commitment to high scientific and ethical standards
- Process improvement mindset; ability to overcome inefficiencies
Compensation / Benefits:
- Base pay range: $190,000–$205,000 annually (varies by location/market/skills/experience); total compensation includes equity, bonus, and benefits
Application instructions:
- Olema does not accept agency resumes; not responsible for fees related to unsolicited resumes