Associate Director, CMC Drug Product Development

Associate Director, CMC Drug Product Development

Join to apply for the Associate Director, CMC Drug Product Development role at Aligos Therapeutics

Associate Director, CMC Drug Product Development

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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

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. 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 regulatory filings.

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., Clinical, Nonclinical, Drug Substance, Quality Assurance, and CDMO Quality Control) and participate on Development Project Teams.

Qualifications

• 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 Skills

• Experience leading manufacturing commercial products with CDMOs.

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 $224,000 – $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, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation please reach out.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Manufacturing

• Industries

  Biotechnology

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