A leading biopharmaceutical manufacturing facility is seeking to recruit a contract Downstream Technology Transfer Manufacturing Technology (MT) Engineer. The Manufacturing Technology group is responsible for process validation and continued technical support for cell culture and primary recovery unit operations in the commercial manufacture of multiple mammalian cell processes. The successful candidate will be a key contributor to a dynamic and highly technical global team, collaborating 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 a new product introduction.
* Possess a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes, with expertise in the following:
* Downstream: Buffer preparation, purification, and viral reduction steps, including chromatography, ultrafiltration, viral reduction filtration, viral inactivation technologies, and drug substance formulation and bulk fill.
* Author technical documents, including protocols, reports, and SOPs, to support validation of the manufacturing process.
* Identify and implement process improvements, such as yield optimization and cycle time reduction, 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 manufacturing investigations into process deviations and resolution strategies.
* Serve as a process subject matter expert for regulatory inspections and interactions with regulatory agencies.
* Document and communicate key findings and insights internally and externally, which may include participation in scientific meetings.
* Identify and support process improvements (through change control or CAPA) and contribute to Lean initiatives at the site.
Qualifications & Experience
* Minimum BSc or equivalent with at least 3 years of experience in drug substance manufacturing technical support within the biopharmaceutical industry, including tech transfer preparation, execution, and post-execution activities.
* Demonstrated awareness of cGMP compliance and regulatory agency requirements.
* Strong oral communication and technical writing skills.
* Excellent interpersonal skills and ability to work effectively in a cross-functional global environment and local group settings.
* Ability to develop, present, and defend technical and scientific approaches in both written and verbal formats.
* Capable of partnering with and influencing stakeholders without direct reporting authority.
* Ability to drive technical decisions while balancing product quality and 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.
Applications are in strict confidence.
Next Generation will never share your data outside of our organisation without your prior written consent.
#J-18808-Ljbffr