Offers “Merckgroup”

39 days agoMerckgroup

Scientist - Virus Bioprocessing

  • 浦东新区, 浦东新区
  • Teaching

Job description

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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 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 set up and maintain the virus process laboratories and equipment in the validated state, 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 Scientist – 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: 
Education: 

· 
Master degree in Chemical Engineering, Biological Sciences or higher degree in related scientific subject 

Experience: 

· 
Minimum 8 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.  

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 
  

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  219819

Location:  Shanghai

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontextf748fab0b60d052d a{ border: 1px solid transparent; } .buttontextf748fab0b60d052d a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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