Manager, Injectable Products
Viking Therapeutics
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Job summary
Viking Therapeutics, Inc. is seeking a Manager, Injectable Products to lead sterile injectable product development, validation, and lifecycle management.
You will partner with Development, Manufacturing, Quality, Regulatory Affairs, and external CMOs/CDMOs to ensure compliant, robust manufacturing processes across product lifecycles. The role requires 8+ years in pharma/biotech manufacturing with hands-on leadership in aseptic processes, PPQ, and regulatory readiness.
Qualifications
- BS or MS in chemical engineering, pharmaceutical sciences, or related field.
- 8+ years of pharma/biotech manufacturing and technical operations.
- Direct experience supporting sterile injectable products from late-stage to launch.
- Experience supporting PPQ, technology transfer, process validation, and commercial manufacturing operations.
- Strong understanding of aseptic processing and regulatory requirements.
- Excellent project management and cross-functional leadership.
Responsibilities
- Provide technical SME leadership for sterile injectable products from Phase 3 through commercial operations.
- Oversee drug product manufacturing processes: formulation, filling, lyophilization, inspection, packaging, distribution.
- Support validation, control strategies, lifecycle management, and process characterization.
- Ensure compliance with FDA/EMA/ICH GMP requirements and regulatory submissions.
- Lead investigations, CAPAs, change controls, and risk assessments for quality events.
- Support technology transfer, CPV, PPQ, and annual product reviews with partners.
Skills
Education
Job description
The Manager, Injectable Products serves as a technical leader and Subject Matter Expert (SME) for sterile injectable drug products across late-stage development, Process Performance Qualification (PPQ), commercial launch, regulatory approval, and lifecycle management activities.
This role provides strategic and hands‑on technical leadership for biologic and small molecule injectable products, including liquid, lyophilized, and combination presentations. The individual will support technology transfer, process validation, commercial manufacturing, regulatory submissions, inspection readiness, and continuous process improvement initiatives.
The position partners closely with Pharmaceutical Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Analytical Development, and external manufacturing partners (CMOs/CDMOs) to ensure robust, compliant, and reliable manufacturing processes throughout the product lifecycle.
The main responsibilities of this role include:
- Serve as the technical SME for sterile injectable products from Phase 3 clinical development through commercial operations.
- Provide technical leadership for drug product manufacturing processes, including formulation, filling, lyophilization, inspection, packaging, and distribution.
- Support process characterization, control strategy development, validation, and lifecycle management activities.
- Ensure compliance with FDA, EMA, ICH, and global regulatory requirements for sterile injectable products.
- Support preparation and defense of CMC content for regulatory submissions, inspections, and agency interactions.
- Provide technical oversight for commercial manufacturing operations involving sterile injectable products.
- Support technology transfer activities between development organizations, CMOs, CDMOs, and commercial manufacturing sites.
- Lead technical investigations associated with manufacturing deviations, process excursions, product quality events, and yield improvements.
- Support PPQ execution, Continued Process Verification (CPV), Annual Product Reviews, and ongoing process monitoring initiatives.
- Identify and implement process improvements that enhance product quality, manufacturing robustness, compliance, and supply reliability.
- Serve as a technical representative during Health Authority inspections and Pre-Approval Inspections (PAI).
- Lead process validation strategies and execution for commercial injectable products.
- Review and approve validation protocols, reports, risk assessments, and change controls.
- Support equipment qualification, cleaning validation, aseptic process simulations, and container closure validation activities.
- Drive lifecycle management activities, including post-approval changes, process optimization, and manufacturing scale-up initiatives.
- Ensure product and process knowledge is effectively transferred and maintained across manufacturing sites.
- Provide technical support for aseptic processing, sterile filtration, filling operations, lyophilization, and visual inspection processes.
- Evaluate manufacturing performance trends and recommend improvements to process capability and operational efficiency.
- Support contamination control strategies and aseptic manufacturing best practices.
- Collaborate with site operations to resolve technical challenges and support uninterrupted product supply.
- Lead complex investigations related to product quality, manufacturing deviations, out-of-specification results, and process performance issues.
- Facilitate root cause analysis and development of effective CAPAs.
- Ensure compliance with GMP requirements and internal quality systems.
- Participate in audits, inspection readiness activities, and regulatory responses.
- Apply Quality Risk Management principles to support decision-making and process improvements.
- Provide technical support for regulatory submissions, supplements, annual reports, and responses to health authority questions.
- Collaborate with Regulatory Affairs and Development teams to support product approvals and post-approval changes.
- Ensure alignment between manufacturing processes, control strategies, and regulatory commitments.
- Support inspection preparation and regulatory agency interactions.
- Provide technical oversight of CMOs, CDMOs, and critical raw material suppliers.
- Support supplier qualification, technical assessments, investigations, and change management activities.
- Collaborate with external partners to resolve manufacturing and quality challenges.
- Evaluate manufacturing capabilities and readiness to support commercial product demand.
- Partner with Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and Engineering functions.
- Support commercialization activities and launch readiness initiatives.
- Drive alignment between internal stakeholders and external manufacturing organizations.
- Contribute technical expertise to strategic product and portfolio decisions.
- Lead technical workstreams supporting product commercialization, process validation, technology transfer, and lifecycle management.
- Mentor junior engineers and scientists within the organization.
- Manage multiple projects and priorities while ensuring timelines, quality standards, and business objectives are achieved.
- Support strategic initiatives within the Injectables & Devices organization.
- Other duties as assigned.
- BS or MS in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemistry, Biology, or related scientific discipline.
- 8+ years of experience in pharmaceutical or biotechnology manufacturing and technical operations.
- Direct experience supporting sterile injectable products from late-stage development through commercial launch.
- Experience supporting PPQ, technology transfer, process validation, and commercial manufacturing operations.
- Strong understanding of aseptic processing, sterile manufacturing, and injectable drug product lifecycle management.
- Experience leading technical investigations, CAPAs, change controls, and risk assessments.
- Knowledge of FDA, EMA, ICH, GMP, and global regulatory requirements.
- Demonstrated experience supporting regulatory inspections and audit readiness activities.
- Strong project management, technical writing, and cross-functional leadership skills.
- Excellent communication and stakeholder management capabilities.
- Technical Operations Leadership
- Process Validation & PPQ Execution
- Aseptic Manufacturing Knowledge
- Commercialization & Lifecycle Management
- Regulatory Compliance & Inspection Readiness
- Quality Risk Management ␠
- Cross-Functional Leadership ␠
- External Partner Management ␠
- Strategic Problem Solving ␠
- Continuous Improvement & Operational Excellence
- Advanced degree (MS, PharmD, or PhD) in Engineering, Pharmaceutical Sciences, or related scientific field.
- Experience with biologics, monoclonal antibodies, peptides, gene therapies, or other sterile injectable products.
- Experience with lyophilized drug products and aseptic filling operations.
- Experience supporting global regulatory submissions and product approvals.
- Experience managing CMOs/CDMOs and global manufacturing networks.
- PMP, Lean Six Sigma, or related certification.
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.
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