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Bioprocessing Associate Scientist
Posted 09 Mar 2023
Shanghai, Shanghai - China
Req Id 259947
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Bioprocessing Associate Scientist I
As Associate Scientist – Virus Bioprocessing you will be part of the Process Solutions Services team that designs and delivers Viral Clearance validation studies for biopharmaceutical companies across the China region. In this role you will perform a variety of GMP/GLP operations, develop and execute processes to manufacture virus lots and conduct client processes for Viral Clearance studies. You will plan and execute virus production and conduct client studies with appropriate regulatory compliance, independently planning and performing cell culture, harvest, chromatographic process, inactivation and filtrations. You will also perform analytical assays to determine virus titer and purity, and coordinate with the lab testing team to ensure timely release of virus lots.
As part of your daily responsibilities, you will initiate and conduct investigations, lead improvement projects, and generate SOP’s as required. The Associate Scientist II – Virus Bioprocessing will work closely with the process team, study management and testing laboratories to manufacture virus lots and execute client studies on time and right first time.
The post holder will be able to perform the following functions.
Brief role description:
- Supports set-up of new facility and executes tech transfer for production of GLP/GMP virus lots
- Performs cell culture, harvest, chromatographic process, inactivation, and filtrations to produce high titer and high purity virus lots
- Performs analytical assays to determine virus purity and titer to ensure timely release of virus lots.
- Plans and executes virus production runs to ensure timely supply for Viral Clearance studies
- Works within the Virus Production and Viral Clearance laboratories following Standard Operating Procedures (SOP) and relevant compliance regulations
- Performs tech transfer and spiking runs of client processes according to the client’s technical documentation and applicable SOP’s
- May prepare client process specific protocols and methods for the performance of chromatography, inactivation, and filtration steps
- Works closely together with the process team, study management, testing laboratories, Quality and PMO to ensure virus production and 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
- Leads investigations and progresses deviation and Corrective or Preventative Action (CAPA) records in a timely manner.
- 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:
- Master’s degree in chemical engineering, Biological Sciences, or higher degree in related scientific subject
- Minimum 5 years of experience in a scientific laboratory role
- Minimum 3 years of experience in a regulated environment (GLP/GMP)
- Demonstrable scientific understanding in downstream bioprocessing (filtration and chromatography)
- Hands-on experience with Akta Pure/Avant systems
- Prior experience in any of the following areas will be desirable:
- Prior experience in MSAT or Process Development (protein purification) in the biopharmaceutical industry
- Experience of working in Biosafety Level 2 laboratory
- Experience in cell culture and virus production
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
- Train The Trainer
- English fluency in speaking and writing.
- 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
Functional Area: Research & Development
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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!