What You Do :
As Process Associate Scientist Viral Clearance you will be part of our Process Solutions 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 GMP / 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 spiking, chromatographic process, inactivation and filtrations.
As part of your daily responsibilities you will also initiate and conduct investigations, lead improvement projects, and generate SOP’s as required.
The Process Associate Scientist will work closely with the process team, study management and testing laboratories 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 (SOP) and relevant compliance regulations
Plans and executes tech transfer of client processes into the BioReliance laboratories according to the client’s technical documentation and SOP’s
Prepares high quality client process specific protocols and methods for the performance of chromatography, inactivation and filtration steps
Independently performs virus spiking, sample preparation and client scale-down purifications for chromatography, inactivation and virus filtration operations
Works closely together with the process team, study management, testing laboratories, Quality and PMO to ensure routine and complex client studies are completed on time, to the appropriate scientific and regulatory standards
Works side-by-side with onsite clients performing scale-down purification operations in the lab
Accurately and promptly records data to meet appropriate scientific and GLP / GMP regulatory standards
May perform virus titration assays to ensure routine studies are completed on time
May write reports for GLP client studies and technical feasibility studies.Initiates and progresses deviation and Corrective or Preventative Action (CAPA) records in a timely manner and performs investigations as required.
Carries out housekeeping, maintains stock control and ensures equipment is 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
Writes protocols, Standard Operating Procedures (SOPs) and workbooks and supports introduction of new Electronic Lab Notebooks (ELN)
Leads lab projects related to new technology / equipment introduction, validations, continuous improvement, Change Controls, CAPA’s and audits
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.
Who You Are : Education :
Bachelor degree in Biological Sciences or higher degree in relevant scientific subject
Minimum 2 years of experience in a scientific laboratory role
Demonstrable scientific understanding in downstream bioprocessing (filtration & chromatography)
Prior experience in any of the following areas will be desirable : Prior experience in a regulated environment (GLP / GMP) Hands-on experience with Akta chromatographic systems Prior experience in MSAT or protein purification Process Development
Knowledge & Skills :
Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
Ability to complete documentation (both handwritten and electronic) neatly and accurately
English fluency in speaking and writing.
Practical knowledge of Japanese and / or Korean is a plus.
Core competencies :
Safety and Quality Adheres to health and safety procedures and actively takes necessary action when encountering unsafe situations Is organized and pays attention to detail Adheres to SOPs and protocols, and ensures compliance to site policies and regulations Takes pride in doing ordinary tasks extraordinarily well
Problem solving and drive Can learn new skills and knowledge quickly Uses logic to solve problems with effective solutions Enjoys working hard;
is action-oriented and determined to provide best-in-class service Pursues everything with energy, drive and the need to finish, especially in the face of resistance or setbacks
Personal and interpersonal skills Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact Is seen as a team player, cooperative and encourages collaboration Is customer oriented and able to relate with clients from different cultures The ability to maintain effective working relationships with scientists and other lab personnel will be critical for success in the role
ADDITIONAL LOCAL NEEDS
Ability to work overtime or flexible shifts from time to time to cover testing requirements