Tech Transfer Engineer

Position Summary

The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.

• Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the clients site.
• Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
• Upstream (Cell culture focus) including media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, single use systems, seed and production bioreactors and harvest centrifugation/clarification).
• Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
• Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
• To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
• To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
• Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Clients site.
• Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings)
• Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.

• Minimum BSc or equivalent with at least 3 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
• You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Can effectively partner with and influence stakeholders without direct solid line authority.
• Drives technical decisions balancing product quality and operational requirements.

Please note that this role may infrequently require periods of extended hours or a modified work schedule and may require on-call availability