Biologics Drug Product Operations Leader

Dechra Pharmaceuticals PLC; Boston (MA); Híbrido; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

Dechra Pharmaceuticals PLC seeks a Senior Manager, Biologics Drug Product Operations to lead external DP CDMOs and manage late-stage development and GMP manufacturing for veterinary biologics. The role drives technology transfer, PPQ readiness, and regulatory submissions while ensuring supply continuity and quality across programs.

The successful candidate will coordinate with CMC Development, Operations, Quality and Regulatory Affairs, with 25–40% travel, and a strong track record in biologics

Formación

• Extensive biologics drug product development and manufacturing experience.
• Experience supervising external CDMOs for GMP DP manufacturing.
• Proven ability to lead cross-functional teams and external partners.
• Strong knowledge of CGMP, CMC documentation and regulatory readiness.

Responsabilidades

• Lead external DP CDMOs and manufacturing partners for clinical, PPQ and commercial GMP programs.
• Manage CDMO performance, schedules, budgets and risk mitigation.
• Act as PiP during critical manufacturing, process validation and PPQ campaigns.
• Provide technical oversight for DP development, manufacturing operations, validation and readiness.
• Drive technology transfer, process characterization and PPQ readiness programs.
• Review manufacturing docs, deviations, investigations and change controls.
• Ensure compliance with CGMP and regulatory expectations for DP products.

Conocimientos

Biologics DP development

CDMO management

PiP during GMP

Process validation

PPQ readiness

Regulatory collaboration

Cross-functional leadership

Process transfer

Risk mitigation

Travel flexibility

Educación

Bachelor/Master/PhD in Life Sciences or Bioprocess

Descripción del empleo

Dechra Pharmaceuticals PLC seeks a Senior Manager, Biologics Drug Product Operations to lead external DP CDMOs and manage late-stage development and GMP manufacturing for veterinary biologics. The role drives technology transfer, PPQ readiness, and regulatory submissions while ensuring supply continuity and quality across programs.

The successful candidate will coordinate with CMC Development, Operations, Quality and Regulatory Affairs, with 25–40% travel, and a strong track record in biologics