Process Associate Scientist III

Posté 02 août 2022

Singapore, Singapore - Singapore

Demander un identifiant 253697

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


YOUR ROLE:

As Process Associate Scientist III – Viral Clearance you will be part of the 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 reduction filtration (VRF) and execute chromatographic process under minimal supervision. As part of your daily responsibilities, you may also support investigations, lead improvement/ lab projects, and generate SOPs as required. The Process Associate Scientist II 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.

  • Works within the Viral Clearance laboratories following Standard Operating Procedures (SOPs) and relevant compliance regulations.
  • May execute tech transfer of client processes into the BioReliance laboratories according to the client’s technical documentation and SOPs, under guidance of Process Scientist.
  • 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 with minimal supervision.
  • Works closely together with study management team, lab study coordinating (LSC) team, end-point testing team, Quality and PMO 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. Able to develop working knowledge of Operational Excellence tools (6S, Six Sigma) to drive Continuous Improvement in lab.  
  • 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.
  • May leads lab projects impacting routine operations and non-complex site-level projects. Supports more complex/global projects led by more senior Process Associate Scientist/Process Scientist/Lab Scientist. Handles events, CAPA's, GCCs impacting own lab team.

 
WHO YOU ARE:

  • Bachelor degree in Chemical Engineering, Biological Sciences or higher degree in related scientific subject.
  • For PAS I, 0 to 2 years of working experience in biologics or biopharmaceutical industry; for PAS II, 2+ years of working experience in biologics or biopharmaceutical industry.
  • For PAS I, preferred >1 year experience in a scientific laboratory role; for PAS II, >2 years experience in a scientific laboratory role with ideally > 1 year in regulated environment (GLP/GMP or equivalent)
  • Hands-on experience in chromatographic systems (AKTA) is a plus
  • Hands-on experience in lab-scale filtration & chromatography (AKTA) is a plus
  • Quality mindset and good understanding of GMP/GLP is a plus
  • Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
  • Ability to complete documentation (both handwritten and electronic) neatly and accurately
  • Ability to work overtime or flexible shifts (around 7AM-4PM or 2-11PM) from time to time to cover testing requirements. May be required to start earlier than 7AM or work later than 11PM at times (not often).

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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