Scientific Technical Specialist (Co. Meath)

We are seeking a Tech Transfer Senior Specialist to join our Client's team at their facility in Co. Meath. This role offers the opportunity to be a key contributor to new product introduction (NPI) and to shape the evolving tech transfer strategy at the site.

Key Responsibilities:

• Collaborate with stakeholders to execute program transfer requirements, including late-stage clinical and PPQ (Process Performance Qualification).

• Lead tier meetings to coordinate activities for new drug substance manufacturing processes.

• Develop process descriptions, models, and related documentation for continuous and fed-batch processes.

• Improve local Tech Transfer procedures to streamline new program introductions while ensuring compliance with quality standards.

• Assist in developing innovative solutions to enhance tech transfer efficiency and reduce risk.

• Promote safety, compliance, and quality at all times.

Requirements:

• Education: Bachelor’s degree in Biotechnology, Engineering, Chemistry, or related field.

• Experience: 5+ years in the pharmaceutical/biotech industry, with experience in project management and cross-functional teams.

• Knowledge of upstream/downstream unit operations for mAb manufacturing.

• Strong problem-solving abilities and experience with GMP-regulated environments.

• Familiarity with automation systems (e.g., DeltaV, MES, eVal) and validation processes.

Preferred Experience:

• 3+ years with quality management and compliance systems.

• Experience with single-use systems and validation documentation.