Senior Technical Operations Lead, CMO Partnerships

ARS Pharmaceuticals Operations, Inc.; San Diego (CA); Vor Ort; USD 140.000 - 175.000; Vollzeit

Benefits dieser Stelle

Equity

401(k) matching

Medical, dental & vision insurance

Zusammenfassung

ARS Pharmaceuticals is seeking a Manager / Senior Manager of Technical Operations to oversee outsourced manufacturing and technology transfer for neffy™, ensuring compliant, reliable, and on-time product supply.

You will lead cross-functional teams, manage external partners, and drive process development, scale-up, and process validation across clinical and commercial campaigns. A strong background in cGMP and regulatory CMC is essential.

Qualifikationen

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or a related scientific/technical discipline; advanced degree preferred.
• Minimum 5 years in Technical Operations, manufacturing, or related field; externalCMO/CDMO experience preferred.
• Experience with drug-device combinations, DSCSA, serialization, and regulatory CMC activities is a plus.

Aufgaben

• Lead cross-functional Technical Operations projects with external partners, managing scope, timelines, budgets, risks, and KPIs.
• Serve as technical operations point of contact for CMOs and internal stakeholders to ensure adherence to plans and supply requirements.
• Oversee formulation development, scale-up, technology transfer, and process validation activities.
• Plan clinical and commercial manufacturing campaigns with CMOs; provide on-site support for manufacturing.
• Review batch records, protocols, reports, and change controls for accuracy and performance.
• Lead investigations and CAPAs for deviations; collaborate with QA for corrective actions.
• Assess changes for technical impact with cross-functional teams on quality, supply, and regulatory.
• Monitor process performance data to identify risks and opportunities for continuous improvement.

Kenntnisse

cGMP knowledge

Technical operations

Project management

Vendor management

Regulatory CMC

Cross-functional collaboration

Data analysis

Ausbildung

Bachelor’s degree in pharmaceutical sciences / chemistry / engineering

Advanced degree (MS/PhD) a plus

Tools

Microsoft Office

Project management tools

Jobbeschreibung

ARS Pharmaceuticals is seeking a Manager / Senior Manager of Technical Operations to oversee outsourced manufacturing and technology transfer for neffy™, ensuring compliant, reliable, and on-time product supply.

You will lead cross-functional teams, manage external partners, and drive process development, scale-up, and process validation across clinical and commercial campaigns. A strong background in cGMP and regulatory CMC is essential.