- Mar 15, 2023
Horizon Therapeutics are currently seeking a Drug Substance Technical Scientist to join their expanding team on a 12 month contract for their manufacturing site in Co. Waterford.
The person will work within a cross functional team in the set-up of lab upstream/downstream and related analytical equipment and processes to allow the establishment of cell culture and downstream processes in the new Tech Dev lab. A key goal is the establishment of scale down models and their qualification to enable process characterization studies. The person will work with the team and external vendors on equipment introduction and installation, verification and qualification. In parallel lab processes including utility commissioning, operation flows, safety risk assessments, chemical introduction processes, consumable ordering, consumable management and documentation will be established to ensure a fully functioning GLP lab.
As a drug substance technical scientist for lab-based drug substance processing you will bring technical knowledge and practical know-how of aseptic technique, cell culture, harvest and downstream processing, chromatography and process analytics. You will work with a cross-functional team introducing new equipment, equipment management and lab management skills, bringing technical capability to help build a lab function to support product and process understanding for the Horizon product portfolio. This is key to the set up of the Technical Development lab function at the Horizon Waterford site as we establish and grow our capability in DS and DP manufacture.
The role requires an agile, questioning approach to problem solving and excellent communication and teamwork and a collaborative mindset.
- Contribute to the set-up of the Waterford Tech Dev Upstream and Downstream lab capability to ensure all required equipment is installed and available for use
- Liaise closely with vendors to support equipment receipt, ordering and vendor set up, vendor and equipment management and installation, verification, familiarisation and training on Upstream/Downstream equipment
- Engage and work with Horizon functions such as IT, Procurement, Legal, and Finance to manage the introduction and set up of lab equipment
- Contribute to the set up and management of lab consumables ordering, reconciliation and replenishment, sample management and waste streams management
- Contribute to the technical transfer of upstream and downstream processes and scale down model establishment and qualification
- Support the establishment of documentation systems to document the introduction and management of equipment, and lab operations documentation (electronic lab notebook)
- Prepare buffer / solutions to support DS/DP/Analytical work as required
- Perform safety risk assessments and promote a safety culture
- Work collaboratively with the Waterford Tech Dev team and the wider stakeholder groups
- Adhere to all site safety, environmental and industrial hygiene procedures and practices.
Qualifications and Skills Required:
- Experience of biologics lab operations including protein solution sample handling, buffer and solution prep, equipment operation and maintenance
- Experience of lab-related procurement processes and managing vendor and equipment purchasing and introduction
- Experience of cell culture processes from shake flask to bioreactor bench scale is desirable.
- Experience with cell culture and /or downstream process analytics and in-process control using on-line and at-line analytics is desirable.
- Minimum of a bachelor's degree in life science or engineering field or diploma qualification plus 2-5 years of experience
- Minimum of 2 years relevant experience in the biotechnology or pharma industry. Direct experience with CHO cell culture bioreactor processing will be a plus.
- Strong planning and tracking skills, capable of managing multiple projects, excellent time management with respect to priorities and self-management
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Excellent written and oral communication skills
- Proficient in Microsoft Office.
- Professional, proactive demeanour.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.