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 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. This individual must have a strong scientific background in solid oral dosage form development and proven track record of experience in cGMP Drug Product Manufacturing at CDMO. The individual must have experience in supporting worldwide wide regulatory filings.

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
• Experience with pre-formulation and early-stage formulation development work to support non-clinical studies.
• A robust understanding of quality requirements for cGMP drug product manufacturing. Knowledge of relevant ICH and compendial (USP/EP) requirements
• Experience managing engineering challenges of large scale solid oral dosage processes involved in manufacturing, such as blending, granulation, compression, and 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 in-depth knowledge and full understanding of GMP requirements
• Experience in leading technology transfer and manufacturing operations with CDMOs
• Experienced with quality systems, identifying and addressing deviations, work on CAPA’s
• Ability to represent Aligos at vendor meetings, on and off-site, 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 (directly and indirectly) and variable workloads with demanding timelines

PREFERRED EDUCATION AND EXPERIENCE:

Experience leading manufacturing commercial products with CDMOs.

ADDITIONAL ELIGIBILITY QUALIFICATIONS/COMPETENCIES

• Effective verbal and written communication skills
• Superb organizational skill and attention to details
• Ability and track record of successfully working in cross-functional teams to progress projects as a representative Drug Product function.
• Ability to proactively navigate issues and be successful in a fast-paced work environment.

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).

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
• Support packaging, labeling activities for finished Drug Product
• 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., Clinical, Nonclinical, Drug Substance, Quality Assurance, and CDMO Quality Control) and participate on Development Project Teams.

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.