Director, Solid Oral Formulations

Viking Therapeutics, Inc.•San Diego, CA

3d•$210,000 - $220,000

About The Position

The Director, Solid Oral Formulation serves as the technical lead and subject matter expert (SME) for oral solid dosage form development, scale-up, validation (PPQ), commercial manufacturing, and lifecycle management. This role is responsible for providing strategic and technical oversight of external CDMO partners supporting Phase 3, registration, commercial launch, and post-approval operations. The Director will lead formulation and process optimization initiatives to ensure robust, scalable, and commercially viable tablet manufacturing processes while maintaining regulatory compliance and inspection readiness. Working cross-functionally with CMC, MSAT, Quality, Regulatory Affairs, Supply Chain, Technical Operations, and external manufacturing partners, this individual will drive successful commercialization, process validation, Pre-Approval Inspection (PAI) readiness, and ongoing process performance verification throughout the product lifecycle.

Requirements

Ph.D., M.S., or equivalent degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or related scientific discipline.
Minimum 12-15 years of pharmaceutical industry experience with increasing responsibility in drug product development and commercial manufacturing.
Extensive experience with oral solid dosage forms, particularly tablet formulation development, scale-up, validation, and commercial manufacturing.
Demonstrated success managing global CDMOs supporting Phase 3, submission, launch, and commercial supply programs.
Direct experience supporting FDA Pre-Approval Inspections (PAIs), regulatory inspections, and commercial approvals.
Experience leading process validation, technology transfer, commercial readiness, and lifecycle management activities for marketed products.
Recognized technical expertise in solid oral dosage form development and commercial tablet manufacturing.
Deep understanding of cGMPs, ICH guidelines, FDA regulations, QbD principles, process validation, and lifecycle management.
Strong knowledge of granulation, blending, tablet compression, coating, packaging, and commercial manufacturing operations.
Experience with process characterization, statistical analysis, DoE, risk management, and control strategy development.
Proven ability to influence internal and external stakeholders in matrix organizations.
Strong leadership, communication, negotiation, and problem-solving skills.
Demonstrated capability to operate effectively in a fast-paced biotech or pharmaceutical environment while managing multiple products and priorities simultaneously.

Responsibilities

Serve as the company's technical SME for solid oral dosage forms, including immediate-release, modified-release, and specialty tablet technologies.
Provide strategic leadership for formulation optimization, process characterization, scale-up, technology transfer, validation, and commercial manufacturing.
Lead development and implementation of control strategies aligned with Quality by Design (QbD) principles and commercial product requirements.
Drive scientific evaluations and risk assessments supporting formulation improvements, process robustness, and manufacturing efficiency.
Provide technical oversight and governance of CDMO partners responsible for Phase 3, registration, exhibit, and commercial tablet manufacturing activities.
Establish performance expectations and ensure execution of manufacturing, validation, stability, and regulatory commitments.
Review and approve manufacturing strategies, process development plans, protocols, reports, investigations, and change controls.
Lead regular technical and operational reviews with CDMO partners to monitor compliance, project execution, quality metrics, capacity planning, and continuous improvement initiatives.
Assess CDMO readiness for commercial supply and regulatory inspections.
Lead process optimization activities focused on blending, granulation, compression, coating, tablet finishing, packaging, and distribution readiness.
Oversee process characterization studies and design-of-experiment (DoE) activities supporting process validation and regulatory filings.
Provide technical leadership for technology transfer activities between development, pilot, and commercial manufacturing sites.
Review and approve validation strategies, including process performance qualification (PPQ), cleaning validation, hold-time studies, and continued process verification programs.
Ensure commercial processes are capable, reproducible, and aligned with established critical quality attributes (CQAs) and critical process parameters (CPPs).
Lead technical preparation for FDA, EMA, MHRA, PMDA, and other regulatory agency inspections.
Serve as the manufacturing and formulation SME during Pre-Approval Inspections (PAI), regulatory audits, and health authority interactions.
Ensure manufacturing processes, development history, technical reports, validation packages, and control strategies support successful regulatory review.
Author, review, and approve CMC regulatory documentation, including Module 3 submissions, amendments, responses to health authority questions, comparability assessments, and post-approval change submissions.
Partner with Quality and Regulatory Affairs to identify and mitigate compliance and regulatory risks.
Support commercial launch readiness activities, including inventory strategy, manufacturing capacity planning, process validation completion, and supply chain risk management.
Lead technical assessments and implementation of process improvements, cost-of-goods reduction initiatives, yield optimization, and manufacturing efficiencies.
Evaluate and approve commercial manufacturing changes through formal change control processes.
Support annual product reviews, continued process verification, deviation investigations, root-cause analyses, and CAPA implementation.
Develop long-term product lifecycle strategies to ensure sustainable commercial supply and regulatory compliance.
Collaborate across Technical Operations, CMC, Quality Assurance, Regulatory Affairs, Clinical Supply, Supply Chain, and Program Management functions.
Communicate technical strategies, risks, mitigation plans, and recommendations to senior leadership and executive management.
Mentor junior scientists and manufacturing professionals while fostering a culture of scientific excellence and operational execution.
Other duties as assigned.