Description
The Associate Director, Formulation Development, assists in the design and development of drug delivery systems, specifically for oral dosage forms and injectables to advance Viking Therapeutics’ pipeline. This role partners closely with internal discovery and development teams and with external CRO/CDMO organizations to drive programs from early development through late-stage clinical development and, as needed, toward commercialization readiness. The Associate Director will translate physicochemical properties and target product profiles into phase-appropriate formulation strategies, evaluating options and designing robust formulations across development stages. This position has responsibility for formulation strategy, process development, and manufacturing support, with an emphasis on oral solid dosage forms and injectable drug products (including subcutaneous presentations). The role will contribute to programs spanning Viking’s portfolio, including small molecule therapies and peptide-based therapies, and will apply life-cycle management principles to enable scalable, reliable, and patient-appropriate dosage forms.
Essential Duties and 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 to ensure alignment 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, and 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 drug product processes.
- Communicate data-driven recommendations through protocols, reports, and presentations; present development strategy, risks, and tradeoffs to technical and executive stakeholders.
- Drive execution in a fast-paced biotech environment, emphasizing scientific rigor, collaboration, and continuous improvement to advance programs to the clinic.
- Other duties as assigned.
Requirements
Education and Experience
- Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline
- At least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications)
Knowledge and Skills
- 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 is a plus.
- Track record of accomplishment in managing CMC drug product projects at early and late development stages.
- Experience enabling external CRO/CDMO to achieve project goals on time and under budget.
- Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment.
Travel Requirements
Approximate travel: less than 10% of the time
