Associate Director, Formulation Development
Viking Therapeutics, Inc.
4 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Associate Director, Formulation Development
Responsibilities:
- Lead governance of external CRO/CDMO partners for formulation and drug product development based on modality fit, technical capability, quality systems, and delivery performance.
- Develop RFPs/SOWs and evaluate technical proposals aligned with target product profile (TPP), CQA/CPP strategy, timelines, and budget.
- Define and execute formulation development and process optimization activities (e.g., preformulation, prototype development, DoE/QbD) to enable scale-up, GMP manufacture, packaging/labeling, and stability programs.
- Own drug product development history and CMC documentation (development reports, control strategy, specifications, tech transfer packages) to support IND-enabling work, clinical supply, and lifecycle improvements.
- Partner cross-functionally (CMC, Analytical, Nonclinical, Clinical Ops, QA, Regulatory, Supply Chain) to align formulation strategy, risk mitigation, and stage-appropriate deliverables.
- Author, review, and approve drug product CMC sections for IND/CTA submissions and amendments (e.g., 3.2.P), including comparability, change controls, and regulatory responses.
- Maintain current knowledge of regulatory requirements, USP/ICH/FDA expectations, and cGMP requirements to ensure compliant, robust, and scalable processes.
- Communicate data-driven recommendations via protocols, reports, and presentations; present development strategy, risks, and tradeoffs to stakeholders.
- Drive execution in a fast-paced biotech environment with scientific rigor, collaboration, and continuous improvement.
Requirements:
- Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline.
- At least 10 years of industry experience (title commensurate with experience/qualifications).
Knowledge and Skills (Required/Preferred):
- Highly familiar with current formulation principles and industry practices.
- Extensive process development/optimization, scale-up, and process validation expertise, with emphasis on solid oral dosage forms.
- Experience with injectable formulations and modern enabling technologies (plus).
- Track record managing CMC drug product projects at early and late development stages.
- Experience enabling external CRO/CDMO to achieve goals on time and under budget.
- Strong written/communication skills, problem-solving abilities, and ability to work effectively with diverse teams.
Travel:
- Approximate travel: less than 10% of the time.
Salary:
- $175,000.00 - $195,000.00 annual salary.
Responsibilities:
- Lead governance of external CRO/CDMO partners for formulation and drug product development based on modality fit, technical capability, quality systems, and delivery performance.
- Develop RFPs/SOWs and evaluate technical proposals aligned with target product profile (TPP), CQA/CPP strategy, timelines, and budget.
- Define and execute formulation development and process optimization activities (e.g., preformulation, prototype development, DoE/QbD) to enable scale-up, GMP manufacture, packaging/labeling, and stability programs.
- Own drug product development history and CMC documentation (development reports, control strategy, specifications, tech transfer packages) to support IND-enabling work, clinical supply, and lifecycle improvements.
- Partner cross-functionally (CMC, Analytical, Nonclinical, Clinical Ops, QA, Regulatory, Supply Chain) to align formulation strategy, risk mitigation, and stage-appropriate deliverables.
- Author, review, and approve drug product CMC sections for IND/CTA submissions and amendments (e.g., 3.2.P), including comparability, change controls, and regulatory responses.
- Maintain current knowledge of regulatory requirements, USP/ICH/FDA expectations, and cGMP requirements to ensure compliant, robust, and scalable processes.
- Communicate data-driven recommendations via protocols, reports, and presentations; present development strategy, risks, and tradeoffs to stakeholders.
- Drive execution in a fast-paced biotech environment with scientific rigor, collaboration, and continuous improvement.
Requirements:
- Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline.
- At least 10 years of industry experience (title commensurate with experience/qualifications).
Knowledge and Skills (Required/Preferred):
- Highly familiar with current formulation principles and industry practices.
- Extensive process development/optimization, scale-up, and process validation expertise, with emphasis on solid oral dosage forms.
- Experience with injectable formulations and modern enabling technologies (plus).
- Track record managing CMC drug product projects at early and late development stages.
- Experience enabling external CRO/CDMO to achieve goals on time and under budget.
- Strong written/communication skills, problem-solving abilities, and ability to work effectively with diverse teams.
Travel:
- Approximate travel: less than 10% of the time.
Salary:
- $175,000.00 - $195,000.00 annual salary.