Manager, Injectable Products

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Injectable Products to drive sterile injectable programs from Phase 3 through commercial operations. You will own technical manufacturing processes, and ensure robust CMC strategies across global regulatory expectations.

You will lead process validation, tech transfer, and lifecycle management while ensuring compliant operations, investigations, and QRM across CMOs/CDMOs. The role requires strong leadership and cross-functional collaboration.

Qualifications

• 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.

Responsibilities

• Serve as sterile injectable drug product 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.

Skills

Sterile injectables

Process validation

Technology transfer

CAPA / root cause analysis

Regulatory compliance

Quality investigations

Leadership / mentorship

Risk assessments

Multi-site coordination

Education

BS in relevant scientific discipline

MS/PharmD/PhD preferred

Job description

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.