Job Description

We are hiring an ADC manufacturing leader, please reachout to me if you have experience in biologics drug product filling, lyophilization and formulation.

Job Description:
As an Assistant General Manager/Deputy General Manager in our Advanced Biologics (ADCs) division, you will ensure the long-term effectiveness of the team by overseeing and executing various activities, including filling, lyophilization, equipment preparation, formulation, buffer preparation, support processing, quality of product and services, comply with all regulatory requirements, and build an inclusive culture of high performance for the team.

Qualifications

• Degree, Master’s or PhD in Biotechnology, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline
• A minimum of 5 years of experience in batch processing, automation, commissioning, and validation in an FDA/HPRA-regulated industry.
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
• Has a technical background in pharmaceutical, biologics, ADCs or similar industries
• Experience of start-ups and/or new product introductions to bio-pharmaceutical/pharmaceutical facilities (Biologics Preferred). Must be able to lead & project manage these activities.
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.
• A minimum of 5 year team direct supervisory experience in a team environment