Sr. Specialist, Engineering (m/f/d)

Overview

In this role you will provide technical leadership and support for the global external manufacturing of commercial sterile drug products. You will partner with contract manufacturers and internal Technical Operations to ensure state-of-the-art processes, drive transfers, and manage investigations and CAPAs. The position offers exposure to senior management and opportunities to lead cross-functional teams on strategic external manufacturing initiatives. You will apply your expertise to maintain compliant, robust manufacturing operations and enable successful regulatory inspections.

Retribuzione / Benefits

annual bonus

long-term incentives

hybrid work arrangements

benefits (unspecified)

competitive compensation

occupational healthcare

Responsabilità

Lead technical issues for global external manufacturing of commercial Drug Product

Provide technical leadership for sterile drug product management within Technical Operations

Support technical transfers of new sterile drug products to contract manufacturing sites

Drive internal and external changes to implement advanced technologies and processes

Lead day-to-day technical activities including troubleshooting, process changes, and new technology implementation

Serve as primary interface on technical matters between Technical Operations and third-party drug product manufacturers

Provide leadership on Change Controls, investigations, CAPAs, and support for Health Authority Inspections

Lead critical technical projects related to manufacturing of commercial sterile drug product

Organize cross-functional teams to manage investigations and CAPA/change control implementations

Coordinate risk assessments and develop innovative solutions for complex issues

Requisiti fondamentali

Bachelor’s degree in engineering, biological/chemistry sciences or related discipline

7+ years in manufacturing (process startup, routine manufacturing, and/or technical transfer)

3+ years in sterile/aseptic Drug Product processing including formulation and filling

Experience in Relationship Management

Cross-functional collaboration

Strong communication skills

Multitasking under tight deadlines

GMP knowledge

Change Control processes

Drug Product Manufacturing validation