Director, Drug Substance CMC

Job Description

Job Description

About Aligos

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 Director/Senior Director Drug Substance CMC will report directly to the VP and Head of CMC and Supply Chain. They will oversee and be responsible for all aspects of drug substance development and manufacturing, including process research & development, scale-up, technology transfer, process qualification/validation, and authoring of CMC dossiers and other regulatory submissions. Effective management of CROs and CDMOs in a virtual development environment will be a crucial skill and capability required to accomplish the functions mentioned.

Essential Functions / Responsibilities:

• Ensures all development activities related to drug substance are aligned with Company's project goals, budgets, and timelines for all stages of development and through registration and commercialization.
• Works collaboratively with internal stakeholder functions such as Project Management, Non-Clinical, Supply Chain, Quality, and Regulatory to meet program goals. Coordinates seamlessly with CMC colleagues overseeing analytical development/quality control, drug product development, and supply chain activities.
• Coordinates with drug product functions and clinical supply chain management to ensure accurate forecasting and timely supply of drug substance. Assists commercial forecasting.
• Manages all regulatory starting material and drug substance development related activities internally and at external CDMO vendors, including oversight of route scouting, scale-up and process research development (PRD), and nGMP & GMP manufacturing.
• Identifies, evaluates, and selects appropriate external partners and CRO/CDMOs. Participates in technical audits during vendor selection.
• Prepare and manage budgets, prepare RFPs, review & approve work orders, and liaise with legal & Quality departments for MSA & QTA agreements.
• Drafts, reviews, and approves drug substance related technical documents, including process research & development reports, master batch record documentation, campaign reports, and change controls. Oversee reviews of executed batch record documentation and provides technical input toward batch release. Drives resolution of deviation & event investigations.
• Takes an active role and applies subject matter expertise to establish phase-appropriate release & shelf-life specifications in collaboration with CMC colleagues. Takes an owner/customer focused attitude to analytical development/validation and stability study data.
• Implements Quality by Design (QbD) and applies risk-based principles to establish the Quality Target Product Profile and required Critical Quality Attributes & Critical Material Attributes, including technical & quality risk assessments, design of experiments, identification of Critical Process Parameters, and implementation of appropriate manufacturing control strategies.
• Ensures that all work is conducted in accordance with applicable policies and procedures, CGMP, and regulatory standards & guidelines. Maintains an excellent understanding of global laws & regulations applicable to the pharmaceutical industry.
• Prepares internal pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review, and approval of the requisite CMC dossiers for IND, IMPD, NDA, MAA, or other filings. Prepares drug substance related responses to health authority questions. Sets an example when contributing to all regulatory authoring and publication.
• Leads and participates in initiatives for improving functional processes and technical operations within CMC. Works with QA to develop appropriate SOPs.
• Assist senior management and participate in due diligence for potential business development efforts with external parties.
• Functions as person-in-plant as needed during manufacturing campaigns.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Required Education and Experience:

• PhD in Advanced Synthetic Organic Chemistry with 10+ years of drug substance process research & development (PRD), manufacturing, and technology transfer experience in the pharmaceutical industry.
• Substantial majority of this relevant experience gained in development of small-molecule drugs and New Chemical Entities (NCEs).
• Majority experience acquired working in innovator/sponsor companies operating in a virtual CMC and pharmaceutical development environment, overseeing external CRO/CDMO vendors.
• Substantial experience supporting late-stage development (Phase 3/registration), including oversight of commercial tech transfer and process performance qualification/validation (PPQ/PV).
• Demonstrable experience as a primary and accountable SME author for drug substance Module 3/CMC dossier content for IND/IMPD/NDAs.
• Excellent working knowledge of CGMPs, regulatory guidance, and compendial requirements, including those of FDA, EMA, ICH, and USP-NF/EP/JP.

Additional Eligibility Qualifications/Competencies

• Driven self-starter. Shows initiative and seeks out & defines required program and job objectives.
• Team oriented. Able to work collaboratively with internal colleagues & external vendors.
• Must be flexible and able to prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks and uncertainty. Exceptional problem-solving skills.
• Superb technical writing, oral, presentation, and interpersonal communication skills.
• Excellent data presentation & analysis skills, including creation of publication quality tables & graphs.
• Fluent power user in the Microsoft ecosystem, including Word and Excel, and PDF publication & editing software such as Adobe Acrobat. Comfortable with electronic records & digital workflows.
• Fastidiously detail-oriented and organized. Impeccable attention to data QC.
• Understands and anticipates the impact of business and commercial needs on advanced-stage drug development. 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

Manage direct reports and/or collaboration with and supervision of consultants or external contractors as needed or assigned.

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 some travel, including both domestic and international (10-20%).

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 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 $245,000 – $324,000 (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.