Director, CMC Quality

Join to apply for the Director, CMC Quality role at Aligos Therapeutics

Join to apply for the Director, CMC Quality role at Aligos Therapeutics

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.

About the Role

The Director, CMC Quality will report to the Executive Director, Quality Assurance and will be responsible for providing Quality oversight and support of cGMP-related CMC activities for Aligos Therapeutics’ development programs to assure that project timelines and deadlines are met efficiently while ensuring that CMC activities adhere to GxP requirements. This role interacts with a broad range of GxP functions. This is an exciting opportunity to make an impact in helping to further define and evolve this function at Aligos.

Responsibilities

• Working with Aligos Quality, Regulatory, and CMC team members in developing strategies for Aligos’ programs to ensure cGMP compliant manufacture of high-quality clinical supplies and potential commercial products across all phases of clinical development.
• Providing guidance to the Aligos CMC teams on the requirements for the progression of products through all clinical phases to commercialization in compliance with applicable regulations.
• Overseeing internal and vendor GMP-related activities from a Quality and Compliance perspective and tracking vendor performance.
• Working with the Quality team to develop and implement Quality programs and policies to ensure compliance with all relevant regulations and promote exacting standards for product quality, study integrity, data integrity, and assurance of patient safety.
• Working with the CMC team in developing Standard Operating Procedures and internal processes for CMC and Quality GMP functions.
• Working with the Head of Quality on the planning and conduct of CDMO audits and CDMO Quality Agreements.
• Identifying potential program level, study-level, and batch-level CMC Quality-related risks and working with colleagues in developing mitigation strategies and communicating risks to relevant parties.
• Managing/participating in all aspects of CMC Quality
• Review and approval of manufacturing batch records across the supply chain.
• Review and approval of analytical testing across the supply chain.
• Disposition of materials at each stage of production.
• Assessment of appropriateness and risk of proposed process and analytical changes, deviations, OOSs/OOTs, complaint investigations, and other development data and plans.
• Assessment of stability plans/protocols/data/reports and shelf-life dating.
• Planning and assessment of test method and process validation activities.
• Working with QP teams to facilitate the release/certification of materials for shipment or release in regions outside of the US.
• Promoting the concepts of ALCOA+4, SQUIPS, GxP, and Quality principles throughout Aligos.
• Developing Quality initiatives to direct procedural and process improvements, including assisting the Quality team in developing and maintaining the Aligos electronic Quality Management System.

Qualifications

• BS/MS Degree with 10+ years of relevant progressive quality management experience related to oversight of drug development.
• Demonstrated experience in the biopharmaceutical industry including an ability to operate in a matrixed project team environment which includes all cross-functional aspects of drug development (e.g., nonclinical, CMC, regulatory, clinical, etc.) to achieve quality goals.
• Demonstrated experience of small molecule CMC quality oversight for manufacturing and release of drug substance, drug product, and worldwide clinical supplies through late-stage development.
• Advanced knowledge of GxP Quality principles, concepts, regulations, industry practices and standards, especially as they relate to cGMP-activities.
• High level of oral and written communication proficiency, organizational skills, and detailed oriented mindset.
• Evidence of strong critical, strategic, and analytical thinking skills.
• Demonstrated record of accomplishment; proven track record of ability to build and manage relationships with CDMO partners.
• Experience with computerized systems requirements/regulations as these relate to laboratory testing, manufacturing processes, and overall data integrity.
• Demonstrated ability to implement risk management tools.

Required Skills

• Experience in oligonucleotide CMC quality oversight desired but not essential.
• Experience in leading quality aspects of product commercialization.

Preferred Skills

• Ability to adapt quickly, succeed in a team environment, and learn new tasks independently.
• Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams.
• The successful candidate must be flexible and adaptable to the needs of a small company.

Pay range and compensation package

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 – $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.

Equal Opportunity 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,

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Biotechnology and Biotechnology Research

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