Downstream Technical Services Specialist

Downstream Technical Services Specialist

Are you ready to make a difference in the world of biopharmaceuticals? As a Downstream Technical Services Specialist, you'll play a pivotal role in supporting the cGMP manufacture of biological bulk drug substances at Alexion's facility in Blanchardstown, Dublin. Your expertise will be crucial in technology transfer, process validation, and routine commercial manufacturing for Downstream processes. Collaborate with various departments to ensure successful facility startup and process qualification, while driving timely completion of milestones related to new product introduction and process validation. Are you up for the challenge?

Accountabilities:

• Provide process expertise in Downstream purification processes including buffer preparation, purification, viral reduction steps, and DS formulation.
• Author and review technical documentation, gap assessments, protocols, reports, and validation documentation.
• Lead or support the continuous process verification program at ADMF.
• Support the introduction and changes of raw materials and consumables.
• Collaborate with Quality, Supply Chain, and Manufacturing Operations to ensure material availability and release.
• Identify and implement process improvements for yield and cycle time reduction.
• Generate documentation protocols and lead plant supporting studies at commercial scale.
• Provide on-the-floor support for troubleshooting processing issues and lead investigations into process deviations.
• Lead key process changes using change control systems.
• Ensure compliance with Quality and Safety standards, liaise with global groups, and provide technical support during audits.
• Author and review CTD sections for regulatory submissions.
• Serve as a subject-matter expert during regulatory agency inspections.

Essential Skills/Experience:

• Minimum 3+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
• Technical and operational knowledge of multiple unit operations in cell culture processing.
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
• Ability to present and defend technical and scientific approaches in both written and verbal form.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Experience of Technology Transfer activities is advantageous.
• Knowledge or experience of start-up or systems would be ideal.
• Detail orientated.
• Technical writing competency.

Desirable Skills/Experience:

• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• Experience of authoring CMC sections of regulatory submissions.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives and your contributions are valued. Our commitment to serving patients drives everything we do, fostering a culture of inclusiveness and integrity. With a rapidly expanding portfolio, you'll have the opportunity to grow alongside exceptional leaders and peers who are dedicated to making a difference. Embrace the entrepreneurial spirit and autonomy of a leading biotech while enjoying tailored development programs that align your growth with our mission.

Ready to join us on this exciting journey? Apply now and be part of a team that's redefining the future of healthcare!