Process Associate Scientist I – Viral Clearance
1 year contract potential to renew
Company Description:
Our client is an in Healthcare, Life Science, and Electronics company. They are across the globe with innovating science and technology solutions to enrich people’s lives. Together, they dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
Your role:
As Process Associate Scientist I – Viral Clearance (VC) you will be part of the Contract Testing Services team that designs and delivers Viral Clearance validation studies for biopharmaceutical companies across the APAC region. In this role you will perform a variety of Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) operations and conduct client processes for Viral Clearance studies. You will maintain the process laboratories and equipment in the validated state and conduct client studies with appropriate regulatory compliance under the oversight of the Study Director, independently performing Virus Reduction Filtration (VRF) and execute chromatographic process under supervision of more senior process associate scientists. As part of your daily responsibilities, you may support investigations of events and improvement projects. The Process Associate Scientist I will work closely with the rest of process team, study management, Lab Study Coordinating (LSC) team and end-point testing team to execute client studies on time and right first time.
The post holder will be able to perform the following functions.
Brief role description:
- Works within the Viral Clearance laboratories following Standard Operating Procedures (SOPs) and relevant compliance regulations.
- May prepare high quality VRF (nanofiltration) workbooks.
- Independently performs client scale-down virus nanofiltration operations, and work closely with VRF vendor to ensure VRF process is completed according to schedule.
- Execution of client’s scale-down chromatographic processes under supervision of more senior process associate scientists.
- Works closely together with study management team, lab study coordinating (LSC) team, end-point testing team, Quality and project managers to ensure client studies are completed on time, to the appropriate scientific and regulatory standards.
- Accurately and promptly records data to meet appropriate scientific and GLP/GMP regulatory standards.
- May support in investigations of study deviations/laboratory events as required.
- Housekeeping of labs: performs weekly/monthly cleanings/inventory/housekeeping. Ensure that consumables needed in the client labs are available throughout the week (when studies are on-going).
- To support Point Of Contact (POC) of each client lab in all activities that pertain to general daily housekeeping & maintenance of the labs.
- Ensures equipment in labs are maintained in the validated state with timely implementation of periodic maintenance and calibration.
- Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace.
- May support in writing/revising Standard Operating Procedures (SOPs) and workbooks.
- Supports lab projects impacting routine operations.
BioReliance (Process Solution Services)
- May need to support other VC teams in carrying out various lab activities which can include Spiking, Collection, Reads and Computing etc.
The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.
Requirements
- Min Degree in any Science field with minimum 1 year of related experience
- Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
- Ability to complete documentation (both handwritten and electronic) neatly and accurately
Interested parties, please click on APPLY button. Alternatively, you can share your CV at joleyn.chin@randstadsourceright.com.sg
EA License: 94C3609
Reg No: R1440247
