Overview
Senior Recruitment Consultant | Science and Engineering | Force Recruitment
Role Details
Role Title: Manufacturing Technology (MT) Scientist
Role Location: Dublin 15
Role Type: 12 month Contract
Responsibilities
* Deliver tech transfer readiness activities from facility assessment through PPQ execution and report completion for a new product introduction.
* Demonstrate thorough knowledge of the science behind the molecule and manufacturing processes, with focus on:
* Upstream (Cell culture focus): media preparation, large-scale cell culture bulk drug substance manufacturing (vial thaw, scale up, single use systems, seed and production bioreactors, harvest centrifugation/clarification).
* Downstream: buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration, viral inactivation technologies, and DS formulation and bulk fill.
* Author technical documents, including protocols, reports and SOPs supporting validation of the manufacturing process.
* Identify and implement process improvements (e.g., yield, cycle time) through evaluation of process performance using data analytics tools.
* Generate documentation protocols and lead execution of plant-supporting studies and technical studies on the manufacturing floor at commercial scale.
* Provide on-the-floor support for troubleshooting processing issues and lead investigations into process deviations and resolutions.
* Provide process subject matter expertise for regulatory inspections and interactions with regulatory agencies, representing the site.
* Document and 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 Lean initiatives at site.
Qualifications & Experience
* 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.
* Awareness of cGMP compliance and regulatory agency requirements; strong oral communication and technical writing skills.
* Good interpersonal skills with ability to work in a cross-functional global matrix organization and in local group settings.
* Ability to develop, present and defend technical and scientific approaches in written and verbal form.
* Ability to partner with and influence stakeholders without direct solid-line authority; balance product quality and operational requirements in technical decisions.
Seniority
* Mid-Senior level
Employment Type
* Contract
Job Function
* Manufacturing
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