Senior Recruitment Consultant - Responsible for the Irish Life Science Sector
Company Profile:
Here at Hays, we have a fantastic opportunity with our globally renowned biopharmaceutical client based in Dublin who is actively seeking an experienced Downstream Technology Transfer Engineer to join their team. The company has experienced rapid growth in recent years and currently boasts a large product portfolio across various therapeutic fields such as immunology and oncology.
Job Function:
The person will be 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 the facility.
Core Responsibilities:
* Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction.
* Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
* 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.
* Identify and implement process improvements, e.g., yield, cycle time reduction through evaluation of process performance using data analytics tools.
* Generate documentation protocols and lead the 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.
* Provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the 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 the implementation of Lean initiatives at site.
* Minimum of 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.
* Demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
* Good interpersonal skills coupled with a 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.
* Effectively partner with and influence stakeholders without direct solid line authority.
* Drive technical decisions balancing product quality and operational requirements.
Key Features:
* Opportunity to work with a like-minded team of professionals, gaining valuable hands-on experience that will stand to you in your next project.
* Get a foot in the door with a company that has a diverse global framework while making a local impact.
* Be part of an innovative culture that fosters the growth of top talent.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Science
Industries
Staffing and Recruiting, Biotechnology Research, and Pharmaceutical Manufacturing
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