Contract Upstream/Downstream Technology Transfer MT Engineer
My client is seeking a contract upstream and/or downstream technology transfer MT engineer to join the Manufacturing Technology group. This team is responsible for process validation and continued process technical support to cell culture and primary recovery unit operations for the commercial manufacture of multiple mammalian cell processes in a multi product facility. The successful candidate will be a key contributor to a dynamic and highly technical global team, working closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Global Regulatory Sciences groups.
Key Responsibilities
* Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for new product introductions.
* Demonstrate thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes, including:
* Upstream (Cell culture): media preparation, large scale bulk drug substance manufacturing (vial thaw, scale up, single use systems, seed and production bioreactors, harvest centrifugation/clarification).
* Downstream: buffer preparation, purification, viral reduction steps (chromatography, ultrafiltration, viral reduction filtration, viral inactivation), DS formulation and bulk fill.
* Author technical documents including protocols, reports, and SOPs to support manufacturing process validation.
* Identify and implement process improvements such as yield and cycle time reduction through data analytics.
* Generate documentation protocols and lead execution of plant support studies and technical studies at commercial scale.
* Provide on the floor support for troubleshooting issues and lead investigations into process deviations.
* Act as a subject matter expert for regulatory inspections and interactions with regulatory agencies.
* Document and communicate work and learnings internally and externally, which may include participation at scientific meetings.
* Identify or support process improvements (via change control or CAPA) and contribute to Lean initiatives on site.
Qualifications & Experience
* Minimum BSc or equivalent with at least 3 years of experience in drug substance manufacturing technical support in the biopharmaceutical industry, including tech transfer activities.
* Strong knowledge of cGMP compliance and regulatory agency requirements.
* Excellent oral communication and technical writing skills.
* Strong interpersonal skills and ability to work effectively in a cross-functional global matrix environment.
* Proven ability to develop, present, and defend technical and scientific approaches both in writing and verbally.
* Ability to influence stakeholders and drive technical decisions that balance product quality with operational requirements.
The Next Step for you
Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
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