Process Lead

Role Summary

Process Lead at AstraZeneca, responsible for leading bioprocessing activities within a cGMP and process development setting to accelerate product candidates into the clinic, with expertise in cell culture, purification, and related support activities. This role involves representing the processing area as a Subject Matter Expert, supporting investigations, CAPAs, and tech transfer information, and leading manufacturing execution and process improvements.

Responsibilities

• Lead manufacturing execution and drive process improvements in the Clinical Biologics team.
• Represent the processing area as a Subject Matter Expert, supporting investigations, CAPAs, and tech transfer information.
• Apply adaptable, science-driven approaches to accelerate product candidates into the clinic.
• Develop expertise in cell culture, purification, and downstream processing operations.

Qualifications

• Required: Bachelor's degree in a science or engineering field with minimum 4+ years' biotechnology or pharmaceutical industry experience.
• Required: Ability to perform work with minimal direction.
• Required: Strong technical knowledge to achieve project targets in a timely fashion and to quality standards.
• Required: Demonstrated scientific knowledge development and capability, with potential specialist expertise in a specific area.
• Required: Logic, decision-making, critical thinking, and troubleshooting skills with long-lasting influence on outcomes.
• Required: Excellent verbal and written communication skills; ability to interact with multiple departments.
• Required: Ability to work in a team environment and lead a team of peers.
• Required: Proficiency in downstream operations such as chromatography, virus inactivation/filtration, ultrafiltration/diafiltration, various filtration techniques, antibody-drug conjugate processing, and related downstream processing.

Desirable Skills/Experience

• Strong communication and engagement abilities; independent and self-starting with minimal supervision.
• Experience in biologics process development and/or cGMP manufacturing.
• High drive and initiative; ability to develop new techniques and methodologies.
• Experience in investigation and troubleshooting methodology; leadership, organization, and time management skills.
• Flexibility and willingness to adapt ways of working; experience with continuous manufacturing processing.

Education

• Bachelor's degree in science or engineering field (as noted in Qualifications).