Associate Director, Analytical Development and Quality Control
Aligos Therapeutics, Inc., South San Francisco, CA, United States
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Associate Director, Analytical Development and Quality Control
Full Time South San Francisco, CA, US
9 days ago Requisition ID: 598752615
Salary Range: $232,000.00 To $271,000.00 Annually
About Aligos
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
The Associate Director, Analytical Development and Quality Control will report to the Director & Head of Analytical Development and Quality Control and will be responsible for providing and executing analytical development strategy for small-molecule candidates from early development through late stage, including analytical method development, validation, and transfer; stability programs; and phase-appropriate specifications and analytical control strategies for drug substance (DS), drug product (DP), and related critical materials. The role will manage external CRO/CDMO partners in a virtual development environment and will collaborate closely with Drug Substance, Drug Product, Supply Chain, Quality, Regulatory, Nonclinical, and Clinical teams to achieve program goals.
Essential Functions / Responsibilities
Develops and executes phase-appropriate analytical strategies and plans to support development of small-molecule candidates (preclinical through Phase 3 and registration readiness), aligned with project goals, budgets, and timelines.
Leads external CRO/CDMO activities for analytical method development, optimization, validation, verification, and transfer for assay, purity/impurities, and discriminating dissolution methodologies; supports identification/qualification of impurities and degradation products; reference standard qualification; and physical (solid-state) characterization as needed.
Develops and maintains phase-appropriate analytical control strategies for DS and DP, applying risk-based principles and Quality by Design (QbD) concepts where appropriate.
Designs, manages, and monitors DS and DP stability programs, ensuring protocols, pulls, testing, and reporting support clinical supply needs and regulatory objectives (including retest and expiration dating, and their extension through appropriate extrapolation).
Reviews and quality-checks analytical data packages (e.g., batch release, stability, validation/verification packages), ensuring scientific soundness, traceability, and appropriate conclusions.
Partners with CRO/CDMOs and internal stakeholders to troubleshoot analytical issues and lead/support investigations (e.g., OOS/OOT, deviations), including definition of root cause, CAPA recommendations, and change control support as applicable.
Authors, reviews, and approves technical documentation including analytical methods, development reports, validation protocols and reports, stability protocols and reports, specifications, and data summaries.
Serves as the Analytical Development and Quality Control representative on cross-functional project teams and communicates status, risks, mitigation plans, and key decisions at program and functional meetings.
Contributes to regulatory submissions by authoring/reviewing analytical sections of CMC dossiers (e.g., IND/IMPD, NDA/MAA) and supporting responses to health authority questions.
Supports selection and oversight of external vendors, including technical evaluations, scope definition, RFP inputs, and participation in vendor audits as needed.
Manages budgets for analytical development activities and supports contracting workflows (e.g., SOW review, work order approvals) in coordination with internal partners.
Participates in initiatives to improve functional processes and technical operations within CMC, including development/revision of SOPs in collaboration with Quality.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Required Education and Experience
PhD in analytical chemistry with over 10 years, or Master's with 15 years of analytical development and Quality Control in pharmaceuticals; experienced with cGMP and drug development regulations.
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.
Additional Eligibility Qualifications/Competencies
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.
Work Authorization / Security Clearance
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.
Physical Requirements
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).
Travel
This position is located in South San Francisco, CA and may require a limited amount of travel ( 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.
This position works in both a standard office setting.
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 Aligos 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 $232,000 to $271,000 (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.
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Associate Director, Analytical Development and Quality Control
Full Time South San Francisco, CA, US
9 days ago Requisition ID: 598752615
Salary Range: $232,000.00 To $271,000.00 Annually
About Aligos
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
The Associate Director, Analytical Development and Quality Control will report to the Director & Head of Analytical Development and Quality Control and will be responsible for providing and executing analytical development strategy for small-molecule candidates from early development through late stage, including analytical method development, validation, and transfer; stability programs; and phase-appropriate specifications and analytical control strategies for drug substance (DS), drug product (DP), and related critical materials. The role will manage external CRO/CDMO partners in a virtual development environment and will collaborate closely with Drug Substance, Drug Product, Supply Chain, Quality, Regulatory, Nonclinical, and Clinical teams to achieve program goals.
Essential Functions / Responsibilities
Develops and executes phase-appropriate analytical strategies and plans to support development of small-molecule candidates (preclinical through Phase 3 and registration readiness), aligned with project goals, budgets, and timelines.
Leads external CRO/CDMO activities for analytical method development, optimization, validation, verification, and transfer for assay, purity/impurities, and discriminating dissolution methodologies; supports identification/qualification of impurities and degradation products; reference standard qualification; and physical (solid-state) characterization as needed.
Develops and maintains phase-appropriate analytical control strategies for DS and DP, applying risk-based principles and Quality by Design (QbD) concepts where appropriate.
Designs, manages, and monitors DS and DP stability programs, ensuring protocols, pulls, testing, and reporting support clinical supply needs and regulatory objectives (including retest and expiration dating, and their extension through appropriate extrapolation).
Reviews and quality-checks analytical data packages (e.g., batch release, stability, validation/verification packages), ensuring scientific soundness, traceability, and appropriate conclusions.
Partners with CRO/CDMOs and internal stakeholders to troubleshoot analytical issues and lead/support investigations (e.g., OOS/OOT, deviations), including definition of root cause, CAPA recommendations, and change control support as applicable.
Authors, reviews, and approves technical documentation including analytical methods, development reports, validation protocols and reports, stability protocols and reports, specifications, and data summaries.
Serves as the Analytical Development and Quality Control representative on cross-functional project teams and communicates status, risks, mitigation plans, and key decisions at program and functional meetings.
Contributes to regulatory submissions by authoring/reviewing analytical sections of CMC dossiers (e.g., IND/IMPD, NDA/MAA) and supporting responses to health authority questions.
Supports selection and oversight of external vendors, including technical evaluations, scope definition, RFP inputs, and participation in vendor audits as needed.
Manages budgets for analytical development activities and supports contracting workflows (e.g., SOW review, work order approvals) in coordination with internal partners.
Participates in initiatives to improve functional processes and technical operations within CMC, including development/revision of SOPs in collaboration with Quality.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Required Education and Experience
PhD in analytical chemistry with over 10 years, or Master's with 15 years of analytical development and Quality Control in pharmaceuticals; experienced with cGMP and drug development regulations.
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.
Additional Eligibility Qualifications/Competencies
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.
Work Authorization / Security Clearance
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.
Physical Requirements
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).
Travel
This position is located in South San Francisco, CA and may require a limited amount of travel ( 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.
This position works in both a standard office setting.
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 Aligos 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 $232,000 to $271,000 (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.
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