Engineer, Sterile Drug Product

The Engineer of Sterile Drug Product provides strategic leadership and technical oversight for sterile injectable drug product manufacturing, technology transfer, and process validation activities across Viking Therapeutics’ pipeline. Working within Technical Operations and in close partnership with internal Chemistry, Manufacturing and Controls (CMC), Device Development, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams, this role serves as the senior technical leader accountable for drug product manufacturing strategy and oversight of external fill-finish contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and critical component and raw material suppliers.

The Engineer will lead the strategy and oversee execution of technology transfer, process characterization, control strategy development, Process Performance Qualification (PPQ), and Continued Process Verification (CPV) for aseptically manufactured parenteral drug products, including peptide drug products filled into prefilled syringes and vials, and will provide technical oversight of clinical and commercial-scale manufacturing campaigns. The role will be accountable for the technical quality and alignment of drug product manufacturing and process validation content in CMC documentation and regulatory submissions supporting Viking’s lead GLP-1/GIP dual agonist program (VK2735) and additional metabolic and endocrine disorder pipeline assets.

The Engineer will establish priorities, guide cross-functional technical decisions, and align manufacturing plans, resources, and risk mitigation with program milestones and commercial readiness.

• Serve as the strategic and technical lead for sterile injectable drug product manufacturing across assigned programs, including formulation compounding, sterile filtration, aseptic filling into prefilled syringes, cartridges, and vials, and drug product inputs to combination product assembly.
• Provide strategic technical oversight of drug product CMOs, CDMOs, and critical component and raw material suppliers, including leadership of technical evaluations for supplier selection and qualification, facility and equipment fit assessments, and management of supplier technical and quality performance in partnership with Quality and Supply Chain.
• Lead technology transfer strategy and oversee execution and scale-up of drug product manufacturing processes into clinical and commercial fill-finish sites, including gap and risk assessments, transfer protocols and reports, and engineering and demonstration batches, and provide senior technical oversight and serve as Person-in-Plant during key manufacturing campaigns as needed.
• Direct process characterization and control strategy development consistent with ICH Q8, Q9(R1), Q10, and Q12, including process risk assessments (e.g., FMEA), linkage of process parameters to critical quality attributes, and definition of proven acceptable ranges.
• Establish and lead the process validation strategy consistent with FDA Process Validation guidance and EU GMP Annex 15, including PPQ strategy, protocols, execution oversight, and reports, and oversee establishment and ongoing governance of Continued Process Verification (CPV) programs.
• Provide technical direction and oversight for aseptic processing unit operations, such as compounding and mixing, sterile filtration and filter validation, filling and stoppering or plunger placement, lyophilization as applicable, and visual inspection, consistent with 21 CFR Parts 210 and 211, FDA aseptic processing guidance, and EU GMP Annex 1.
• Oversee the technical adequacy of contamination control strategies and…