Director/Senior Director, MSAT
Viking Therapeutics, Inc.
June 26, 2026
Remote friendly (San Diego, CA)
United States
Operations
Director / Senior Director of Manufacturing Science and Technology (MSAT)
Responsibilities:
- Lead and direct the MSAT function across external CDMO/CMO partners to support clinical and commercial product supply.
- Develop, implement, and maintain MSAT strategies, standards, and governance for lifecycle management, validation, and manufacturing performance.
- Provide technical oversight for manufacturing processes, validation programs, process monitoring, and continuous improvement.
- Lead external manufacturing technical governance, including technology transfers, validation readiness, and commercial launch support.
- Oversee creation/review/approval of validation master plans, process control strategies, and lifecycle documentation.
- Ensure execution of manufacturing and validation in compliance with global regulatory requirements, cGMP, and data integrity expectations.
- Lead technical governance/business reviews with partners to monitor performance, resolve escalations, and drive operational excellence.
- Direct process validation across lifecycle stages: process design, performance qualification, and continued process verification.
- Support regulatory inspections, audits, investigations, deviations, CAPAs, and regulatory submissions.
- Coordinate cross-functional technology transfer initiatives to ensure process transfer, comparability, and readiness.
- Partner with Quality, Regulatory, Supply Chain, R&D, Commercial, and external stakeholders to execute strategic objectives.
- Build, lead, and mentor team members (where applicable).
Requirements:
- MS/Ph.D. in chemical engineering, chemistry, pharmaceutical sciences, or related field.
- 12+ years in MSAT, process validation, and technical operations in pharma/biotech.
- Experience overseeing CDMOs/CMOs in external/virtual manufacturing.
- Leadership in strategy development, cross-functional execution, and team management.
- Expertise in process validation, lifecycle management, and technology transfer.
- Preferred: sterile, oral solid dosage, biologics, peptides, or high-potency manufacturing.
Knowledge & Skills:
- Knowledge of ICH/FDA/EU; expertise in validation, QbD, CPV, and statistical analysis.
- Ability to lead complex global cross-functional initiatives in regulated environments.
- Strong communication, negotiation, stakeholder management, analytical/problem-solving, and attention to detail.
- Dependable, self-motivated, collaborative, and professional.
Compensation:
- $190,000.00 - $220,000.00 annual salary.
Responsibilities:
- Lead and direct the MSAT function across external CDMO/CMO partners to support clinical and commercial product supply.
- Develop, implement, and maintain MSAT strategies, standards, and governance for lifecycle management, validation, and manufacturing performance.
- Provide technical oversight for manufacturing processes, validation programs, process monitoring, and continuous improvement.
- Lead external manufacturing technical governance, including technology transfers, validation readiness, and commercial launch support.
- Oversee creation/review/approval of validation master plans, process control strategies, and lifecycle documentation.
- Ensure execution of manufacturing and validation in compliance with global regulatory requirements, cGMP, and data integrity expectations.
- Lead technical governance/business reviews with partners to monitor performance, resolve escalations, and drive operational excellence.
- Direct process validation across lifecycle stages: process design, performance qualification, and continued process verification.
- Support regulatory inspections, audits, investigations, deviations, CAPAs, and regulatory submissions.
- Coordinate cross-functional technology transfer initiatives to ensure process transfer, comparability, and readiness.
- Partner with Quality, Regulatory, Supply Chain, R&D, Commercial, and external stakeholders to execute strategic objectives.
- Build, lead, and mentor team members (where applicable).
Requirements:
- MS/Ph.D. in chemical engineering, chemistry, pharmaceutical sciences, or related field.
- 12+ years in MSAT, process validation, and technical operations in pharma/biotech.
- Experience overseeing CDMOs/CMOs in external/virtual manufacturing.
- Leadership in strategy development, cross-functional execution, and team management.
- Expertise in process validation, lifecycle management, and technology transfer.
- Preferred: sterile, oral solid dosage, biologics, peptides, or high-potency manufacturing.
Knowledge & Skills:
- Knowledge of ICH/FDA/EU; expertise in validation, QbD, CPV, and statistical analysis.
- Ability to lead complex global cross-functional initiatives in regulated environments.
- Strong communication, negotiation, stakeholder management, analytical/problem-solving, and attention to detail.
- Dependable, self-motivated, collaborative, and professional.
Compensation:
- $190,000.00 - $220,000.00 annual salary.