Manager, Injectable Products
Viking Therapeutics, Inc.
August 17, 2026
Remote friendly (San Diego Metropolitan Area)
United States
$140,000 - $155,000 USD yearly
Operations
Manager, Injectable Products
Responsibilities:
- Serve as sterile injectable drug product technical SME from Phase 3 through commercial operations.
- Lead technical efforts for manufacturing processes: formulation, filling, lyophilization, inspection, packaging, and distribution.
- Support process characterization, control strategy development, validation, and lifecycle management.
- Ensure compliance with FDA/EMA/ICH/global requirements; prepare and defend CMC content for submissions and inspections.
- Provide technical oversight for commercial manufacturing; support technology transfer with CMOs/CDMOs.
- Lead investigations for deviations, excursions, quality events, and yield improvements; support PPQ, CPV, APR, and process monitoring.
- Lead process validation strategy/execution and review/approve validation protocols, reports, risk assessments, and change controls.
- Support aseptic processing, sterile filtration, aseptic simulations, and container closure validation; drive contamination control best practices.
- Lead quality investigations, RCA, CAPAs; support GMP compliance, audits/inspection readiness, and QRM.
- Provide technical regulatory support (submissions, supplements, annual reports) and inspection preparation.
- Oversee suppliers/CMOs/CDMOs; evaluate readiness/capability to meet demand.
- Lead technical workstreams, mentor junior staff, and manage multiple priorities.
Requirements:
- BS/MS in relevant scientific discipline.
- 8+ years in pharma/biotech manufacturing and technical operations.
- Experience supporting sterile injectables from late-stage development to commercial launch.
- Experience with PPQ, technology transfer, process validation, and commercial manufacturing.
- Strong aseptic/sterile manufacturing and injectable lifecycle knowledge.
- Experience leading investigations, CAPAs, change controls, and risk assessments; FDA/EMA/ICH/GMP knowledge.
- Demonstrated inspection/audit readiness experience.
Preferred:
- MS/PharmD/PhD.
- Experience with biologics/monoclonal antibodies/peptides/gene therapies.
- Lyophilized products and aseptic filling experience.
- Global regulatory submission/approval experience.
- CMO/CDMO/global network management; PMP/Lean Six Sigma certification.
Responsibilities:
- Serve as sterile injectable drug product technical SME from Phase 3 through commercial operations.
- Lead technical efforts for manufacturing processes: formulation, filling, lyophilization, inspection, packaging, and distribution.
- Support process characterization, control strategy development, validation, and lifecycle management.
- Ensure compliance with FDA/EMA/ICH/global requirements; prepare and defend CMC content for submissions and inspections.
- Provide technical oversight for commercial manufacturing; support technology transfer with CMOs/CDMOs.
- Lead investigations for deviations, excursions, quality events, and yield improvements; support PPQ, CPV, APR, and process monitoring.
- Lead process validation strategy/execution and review/approve validation protocols, reports, risk assessments, and change controls.
- Support aseptic processing, sterile filtration, aseptic simulations, and container closure validation; drive contamination control best practices.
- Lead quality investigations, RCA, CAPAs; support GMP compliance, audits/inspection readiness, and QRM.
- Provide technical regulatory support (submissions, supplements, annual reports) and inspection preparation.
- Oversee suppliers/CMOs/CDMOs; evaluate readiness/capability to meet demand.
- Lead technical workstreams, mentor junior staff, and manage multiple priorities.
Requirements:
- BS/MS in relevant scientific discipline.
- 8+ years in pharma/biotech manufacturing and technical operations.
- Experience supporting sterile injectables from late-stage development to commercial launch.
- Experience with PPQ, technology transfer, process validation, and commercial manufacturing.
- Strong aseptic/sterile manufacturing and injectable lifecycle knowledge.
- Experience leading investigations, CAPAs, change controls, and risk assessments; FDA/EMA/ICH/GMP knowledge.
- Demonstrated inspection/audit readiness experience.
Preferred:
- MS/PharmD/PhD.
- Experience with biologics/monoclonal antibodies/peptides/gene therapies.
- Lyophilized products and aseptic filling experience.
- Global regulatory submission/approval experience.
- CMO/CDMO/global network management; PMP/Lean Six Sigma certification.