Job Details

Overview

Associate Director, CMC Drug Product Development at Aligos Therapeutics. This role reports to the Senior Director, Drug Product Development, CMC, and manages the development and manufacturing of drug products at CDMOs to support clinical studies. The position level (Associate Director or Director) depends on experience.

This range is provided by Aligos Therapeutics. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$224,000.00/yr - $286,000.00/yr

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

We are seeking a talented individual to join our CMC team. This role will be at the Associate Director or Director level depending on experience and will report to the Senior Director, Drug Product Development, CMC. The person will manage the development and manufacturing of drug products at CDMOs to support our clinical studies. The individual must have a strong scientific background in small-molecule solid oral dosage form development and a proven track record of CMC and pharmaceutical development experience in a virtual development environment. The individual must have experience in supporting worldwide regulatory filings.

Essential Functions / Responsibilities

• Oversee CDMOs to lead the pre-formulation and drug product formulation activities to support the programs from Discovery and into Phase I clinical manufacturing through commercial launch
• Oversight and direction of GMP production activities at contract CDMOs to support later stage clinical trials
• Review and approve master batch records, executed batch records, manufacturing deviations, and investigations
• Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities. Provide technical expertise to troubleshoot manufacturing/packaging process issues
• Generate and/or review experimental plans and lead drug product development activities
• Prepare technical reports in support of planned regulatory submissions
• Write, review and approve CMC portions of regulatory submissions, study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines
• Assist in supply chain logistics for drug product manufacturing activities and clinical trial operations
• Interface effectively with other disciplines (e.g., Regulatory Affairs, Clinical, Nonclinical, Drug Substance, Quality Assurance, and CDMO Quality Control) and participate on Development Project Teams

Required Education and Experience

• Advanced degree (Ph.D.) in pharmaceutics, pharmaceutical science, chemical engineering, or other related scientific disciplines
• 5 to 8+ years of hands-on experience with increasing responsibility in solid oral dosage and sterile drug products and related formulation and manufacturing process development of small-molecule NCEs
• Experience with pre-formulation and early-stage formulation development work to support non-clinical studies
• Robust understanding of quality requirements for cGMP drug product manufacturing. Knowledge of ICH and compendial (USP/EP) requirements
• Experience managing engineering challenges of large-scale solid oral dosage processes (blending, granulation, compression, packaging)
• Experience in writing CMC documents for regulatory submissions (IND/IMPD/NDA/MAA)
• Strong understanding of pharmaceutical development, quality, and regulatory issues
• Hands-on GMP experience with all phases of drug development and full understanding of GMP requirements
• Experience leading development, technology transfer, and manufacturing operations at CDMOs in a virtual/out-sourced development environment
• Experience with quality systems, deviations, CAPAs
• Ability to represent Aligos at vendor meetings and function as a responsible "person in plant" during clinical batch manufacturing
• Experience with enabling technologies for solubility enhancement of BCS class II and IV compounds is a plus
• Ability to flexibly manage tasks and workloads with demanding timelines

Preferred Education and Experience

• Experience manufacturing commercial products at CDMOs

Additional Eligibility Qualifications / Competencies

• Superb verbal and written communication skills
• Superb organizational skills and attention to detail
• Experience working in cross-functional teams to progress projects as a Drug Product function
• Ability to navigate issues successfully in a fast-paced environment

Work Authorization / Security Clearance

All candidates are expected to have authorization to work in the United States.

Supervisory Responsibility

This position may require limited collaboration with and supervision of contractors external to the company.

Position Type and Expected Hours of Work

• This is a full-time position. Hours are Monday through Friday, 40 hours per week.
• Hybrid work model with a minimum of 3 days on-site.

Physical Requirements

• Ability to sit/stand at a desk and use a computer with standard input devices.

Travel

This position is located in South San Francisco, CA and may require travel up to 10%.

Other Duties

Please note this job description is not designed to cover all activities, duties or responsibilities. Duties may change at any time with or without notice.

EEO Statement

Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate based on protected status. Accommodation requests can be directed to Aligos People Operations.

Benefits and Compensation

Aligos provides a competitive benefits package including Medical, Dental, Vision, Life Insurance, Disability, HSA/FSA, 401k, PTO, and Employee Stock Purchase Plan. The anticipated salary range for fully qualified candidates applying for this role is $224,000 – $286,000 (not including discretionary bonus, equity, or benefits).