Engineer, Sterile Drug Product

Job Description

Job Description

Description:

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.

Essential Duties and Responsibilities

The main responsibilities of this role include:

• 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 associated qualification activities at manufacturing partners, including aseptic process simulations (media fills), equipment and cleaning validation, component sterilization, and container closure integrity verification, in partnership with Quality, Device Development and Analytical Development.
• Oversee technical review of executed batch records, and provide senior technical review and approval of manufacturing and validation protocols, reports, risk assessments, and change controls for assigned programs.
• Lead resolution of complex technical issues and oversee technical investigations into manufacturing deviations, out-of-specification and out-of-trend results, process excursions, and product quality events; ensure application of structured root cause analysis methods and guide development and effectiveness verification of CAPAs in partnership with Quality.
• Establish performance expectations and oversee trending of manufacturing performance, including yield, process capability, and in-process and release data, to prioritize and drive improvements in product quality, process robustness, and supply reliability, and oversee technical contributions to Annual Product Reviews as applicable.
• Lead the technical strategy, authoring, and review of drug product manufacturing and process validation content for regulatory submissions (INDs, NDAs/BLAs, MAAs) and post-approval supplements, and lead technical responses to health authority questions in collaboration with Regulatory Affairs.
• Direct assessment of proposed manufacturing changes for technical and regulatory impact, ensure alignment between manufacturing processes, control strategies, and regulatory commitments, and lead drug product technical activities for pre-approval inspection readiness, audits, and agency interactions at manufacturing partners as needed.
• Lead drug product manufacturing strategy for launch readiness and supply continuity activities in partnership with Supply Chain, including evaluation of manufacturing partner capacity and capability, scale-up, and second-source considerations.
• Establish priorities and oversee timelines, deliverables, and technical risks for assigned drug product programs; develop resource and budget recommendations, manage approved external technical scope, and communicate status and risk mitigation recommendations at integrated project team meetings and to Technical Operations leadership.
• Establish expectations for maintaining product and process knowledge across manufacturing sites, monitor emerging regulatory guidance and industry practices for sterile manufacturing, and lead the development of internal procedures, templates, and best practices. Provide technical mentorship and direction to internal colleagues and external partners to build sterile drug product capabilities.
• Other duties as assigned.

Education and Experience

• B.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific or engineering field, with 10+ years of sterile injectable drug product manufacturing, manufacturing science and technology (MS&T), or process development experience in the pharmaceutical or biotech industry; or M.S. with 8+ years; or an equivalent combination of education and experience. 
• Experience in technical leadership of late-stage development or commercial manufacturing programs, external manufacturing partners, and cross-functional teams.

Knowledge and Skills

• Direct, hands-on experience and demonstrated technical leadership in aseptic fill-finish manufacturing of sterile injectable drug products in late-stage clinical and/or commercial operations.
• Demonstrated experience leading technology transfer, PPQ, and process validation for parenteral drug products; experience defining validation strategies and overseeing CPV programs across manufacturing partners.
• In-depth knowledge of applicable regulations and guidance, including 21 CFR Parts 210 and 211, EU GMP Annex 1 and Annex 15, ICH Q8, Q9(R1), Q10, and Q12, FDA aseptic processing and process validation guidance, and relevant USP chapters.
• Strong understanding of aseptic processing unit operations, sterile filtration, contamination control, and visual inspection; experience with lyophilization is a plus.
• Experience leading complex technical investigations, change controls, and CAPAs using structured root cause analysis and Quality Risk Management tools, with demonstrated judgment in resolving manufacturing risks and aligning cross-functional decisions.
• Proficiency with statistical analysis tools (e.g., JMP, Minitab) and statistical methods for process monitoring and characterization, including statistical process control, process capability analysis, and design of experiments.
• Experience providing strategic technical oversight of external CMOs and/or CDMOs and leading partner selection, performance management, technology transfer, and manufacturing oversight, including Person-in-Plant support.
• Strong technical writing skills, including protocols, reports, and investigation records; experience leading the preparation and technical review of CMC drug product content for regulatory submissions and supporting health authority responses and inspection readiness.
• Familiarity with peptide or biologic drug product considerations, such as aggregation, surface adsorption, and sensitivity to shear and temperature, and associated cold-chain requirements; experience with GLP-1 or other peptide injectables, or with prefilled syringe or cartridge filling for combination products, is a plus.
• Demonstrated strategic planning and program leadership skills, including the ability to lead without direct authority within a cross-functional, matrixed team, set priorities, guide resource and budget planning, and mentor technical colleagues.
• Strong written and verbal communication skills, including the ability to present technical recommendations, trade-offs, and risk mitigation plans to senior leadership.
• Entrepreneurial, hands-on mindset with the ability to thrive in a fast-paced, lean biotech environment; strong organizational skills, attention to detail, and the ability to manage multiple priorities and external partners simultaneously.
• Travel requirement 20–25%, including domestic and international visits to manufacturing partners and suppliers.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. #LI-DNI

Salary Description

$200,000.00 - $220,000.00 annual salary