Description
My Client a Leading Pharmaceutical Company based in Belgium requires an IPSA Technician for biologicals.
The Biologics Pilot Plant is manufacturing biological Drug Substance for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.
The mission consists of operational and analytical support to the Biologics Pilot Plant, with special focus on, but not limited to, analytical support to the In-Process Control team as well as supporting the implementation of improvements to SOPs and process related documents (sampling plans, batch records, check-lists, et.al.)
The Biological Pilot Plant is located in Braine-l'Alleud, Belgium.
The role includes primarily, but is not limited to, the following responsibilities:
- Routinely perform analytical testing of IPCs, to ensure a timely monitoring of the GMP and non-GMP process as well as various GMP and non-GMP process samples for understanding of the manufacturing process and relevant product quality attributes >= sometimes work in 14-22h (2-3x/month) and week-ends (4-5x/year)
- Troubleshoot and solve analytical issues on the techniques run in the laboratory.
- Prepare documentation (procedures, protocols, reports, sampling plans, batch records)
- Be involved in the transfer/co-covalidation of analytical methods from other laboratories
- Demonstrate ability to analyse data, with good attention to detail
- Record and double-check analytical data.
- Openly exchange results, observations, and possible improvements
- Present/discuss results in project team meetings
- Contribute in the implementation of new technologies where appropriate.
- Train process operators in performing simple in process analytical procedures on the production floor
- Train other technicians to analytical methods.
- Follow the procedures in place as well as the HSE rules in the laboratory
- Work according the agreed timelines
- Highlight any atypical result or out of specification results according to the established procedures
- Ensure the maintenance and qualification of some analytical equipment
- Contribute to the logistics in the lab (reagent ordering, etc)
- Ensure lab activities are compliant with the GMP procedures (SEM monitoring, 5S )
- Keep the lab tidy and organized.
Experience
- Minimum 2 years' experience in a similar function
- Track record of spending >75% of current and past work function in the laboratory.
COMPETENCIES
Include specific skills, behaviors and knowledge necessary to meet the objectives of the role
- Demonstrate a proactive, flexible and reactive mindset.
- Ability to communicate effectively with good French and English skills, as the post holder will be liaising with colleagues from international sites (Braine, Slough)
- The post holder should have technical knowledge of protein structure and function, and the analytical techniques required to study them. Experience in the operation of, and the analysis with the following analytical equipment: HPLC (Empower), spectrophotometer, electrophoresis, pH-meter, conductivity-meter, osmometer, ELISA, qPCR
- Ability to author comprehensive summary.
- Strong laboratory skills
- Demonstrate ability to analyze data, with good attention to detail
- Ability to multi-task and to organize and communicate large amounts of data.
- Good Interpersonal skills to communicate and maintain good working relationships.
- Ability to work under pressure in a team environment under deadlines and changing priorites.
- Ability to work in a global Matrix and service-oriented environment.
PLEASE QUOTE REF - JSLES1037