Job Details
Director, Analytical Development
2025-08-05 Aligos Therapeutics South San Francisco,CA
Description:
Required Education and Experience:
All candidates are expected to have authorization to work in the United States.
Supervisory Responsibility
This position may require collaboration with and supervision of contractors external to the company.
Position Type and Expected Hours of Work
Travel
This position is located in South San Francisco, CA and may require a limited amount of travel (<10%).
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.
Work Environment
This position works in both a standard office setting as well as in a functional laboratory, with specialized laboratory equipment
EEO Statement:
Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to People Operations.
Benefits and Compensation
Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short- and Long-Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan).
The anticipated salary range for fully qualified candidates applying for this role will be $223,500 - $286,000 (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.
Ready to make a difference in the lives of patients all around the world? As an innovative clinical-stage biotechnology company, that's our top priority.
Founded in 2018 and headquartered in South San Francisco, California, Aligos was founded with the mission to become a leader in the treatment of liver and viral diseases. Our employees thrive in a science-first culture with many critical domains represented on staff. Our team of respected scientists use their decades of experience to build a cutting-edge pipeline of transformative treatment options that have the potential to change lives.
At Aligos, you'll have an opportunity to pursue your passion among the best in the industry. It's a place where you'll be challenged, supported, and inspired. A highly-collaborative, fast-paced work environment where we honor accountability, transparency, and diversity.
Position Summary/About the Team:
TheAssociate Director / Director Analytical Development will report directly to the Senior Director CMC and will be responsible for providing analytical strategy for development of small molecule candidates from Phase I through NDA for both drug substances (DS) and drug products (DP) and contribute to the overall CMC strategy of drug development at Aligos.
Essential Functions / Responsibilities:
- Guide CRO/CDMO to design and perform method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity and dissolution methodologies; compendial methods verification; identification of impurity and degradation products; reference standard qualification, and physical (solid-state) characterization.
- Develop phase-appropriate specifications and quality control strategy for DS and DP.
- Develop and manage phase-appropriate DS and DP stability study programs and ensures retest and expirations dates can support clinical development and regulatory objectives & timelines.
- Review and QC of batch record analytical data packages.
- Help troubleshoot analytical issues and OOS investigations with CRO/CDMO.
- Author analytical development/validation and stability reports and analytical sections in IND/IMPD and NDA/MAA filings
- Coordinate with other CMC functions, QA and Regulatory, Clinical and Toxicology, regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing.
- Serve as the Analytical representative in cross functional project teams
- Interface effectively with other disciplines (e.g., Drug Substance, Drug Product, Quality Assurance, Clinical, Nonclinical, and CDMO QC/QA)
- Assists in the responses to health authority questions.
- Present project progress including critical needs/issues at project meetings.
- Manage budgets for analytical development activities
- Participates in initiatives for improving functional processes and technical operations within CMC at Company.
Required Education and Experience:
- PhD in analytical chemistry with 10+ years of analytical development experience in the pharmaceutical industry, with practical knowledge of cGMP and regulatory expectations for drug development.
- Excellent scientific knowledge in analytical chemistry and experience with using traditional and advanced analytical techniques, including but not limited to HPLC, UPLC, SEC, GC, LC-MS, GC-MS, FTIR, UV, XRPD, PSD, Dissolution.
- Demonstrated track record of managing CROs and CDMOs, preferably on both analytical and bioanalytical projects, in developing methods and quality control strategy for testing of small molecule drug candidates supporting Phase I to commercial launch.
- Demonstrated track record in preparing analytical sections of IND/IMPD and NDA/MAA.
- Experience in preparing, reviewing and submitting required documentation pertaining to the cGMP and GLP environment.
- Excellent verbal and written communication skills.
- Excellent data presentation & analysis skills, including creation of publication quality tables & graphs.
- Fastidiously detail-oriented and organized. Impeccable attention to data QC.
- Ability and proven track record of successfully working in cross-functional teams to progress projects as a representative Analytical function.
- Ability to navigate and be successful in a fast-paced biotech work environment. Distinguishes research from development.
- A desire to be part of a highly innovative company aimed at helping patients with serious diseases.
All candidates are expected to have authorization to work in the United States.
Supervisory Responsibility
This position may require collaboration with and supervision of contractors external to the company.
Position Type and Expected Hours of Work
- This is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week.
- Required to work in a hybrid work model with a minimum of 3 days a week spent on site.
- It is expected that the employee is able to sit / stand at a desk and have full use of a computer through its standard input devices (e.g., mouse and keyboard).
- While in the laboratory, employees will be expected to wear appropriate safety equipment, including a lab coat, gloves, goggles and mask. Appropriate precautions and safety measures are to be followed.
Travel
This position is located in South San Francisco, CA and may require a limited amount of travel (<10%).
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.
Work Environment
This position works in both a standard office setting as well as in a functional laboratory, with specialized laboratory equipment
EEO Statement:
Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to People Operations.
Benefits and Compensation
Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short- and Long-Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan).
The anticipated salary range for fully qualified candidates applying for this role will be $223,500 - $286,000 (not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.