We are looking to hire an ambitious Investigator, Bioanalysis, Immunogenicity and Biomarkers (BIB) China to join our diverse team at GlaxoSmithKline in Dong, Pahang.

Growing your career as a Full Time Investigator, Bioanalysis, Immunogenicity and Biomarkers (BIB) China is an incredible opportunity to develop relevant skills.

If you are strong in decision-making, teamwork and have the right drive for the job, then apply for the position of Investigator, Bioanalysis, Immunogenicity and Biomarkers (BIB) China at GlaxoSmithKline today!

Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18

Posted Date: Feb 20 2023

We have a great opportunity for you in the Bioanalysis, Immunogenicity and Biomarkers (BIB) department at GSK! We are looking for a Bioanalytical Subject Matter Expert (SME) to join Bioanalysis, Immunogenicity and Biomarkers hub in China. The team will support all Pharmacokinetic (PK) Bioanalysis, Immunogenicity and Biomarker data delivery endpoints using various analytical platforms (LC/MS, Immunoassay, Cellular Assays, etc.), primarily China studies but also Asian Pacific or global studies with China involvement. This will support medicines of all modalities (small molecules, oligonucleotides, and Biopharm) and all therapeutic areas (Immunology, Respiratory, Infectious Diseases, Oncology).

The role and group are created to provide on the ground support to a growing number of studies in China with large complexity around assay transfer and cross validations, regulatory submission and approvals, and matrix interactions with both China team and global groups in GSK. The role is based in Shanghai. She/He will be part of BIB China group that also includes one additional staff currently in US.

Key Responsibilities

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include the following:

Provide project accountability to the generation of PK bioanalysis, Immunogenicity, and biomarker data in China CRO providers for Medicine studies, meeting project timelines and in adherence with regulatory compliance to be accepted by the Health Authorities.

Serve as Bioanalytical Subject Matter Expert (SME) member in China study team to partner on study design and executions, particularly around assay feasibility, sampling requirements, assay strategy, CRO placement, data release, report generation, regulatory submissions, and CDE inspections.

Contribute to all BIB activities in China including resource and budgetary planning, reagent and material supplies, permit applications, human sample shipments, technical oversight, business performance tracking, risk management, and issues and resolutions on all BIB deliverables.

Partner with other members in the extended Clinical Development team in China to foster strong collaborations and step changes in performance.

Collaborate with local teams Procurement to deliver CRO selection and provide invoice approvals.

Interface with global partners internal to BIB (e.g., BIB extended leadership team, technical experts, Bioanalytical External Study Monitors) and external to BIB (e.g., Clinical Pharmacology Modeling and Simulations, Clinical Biomarker Leads, DMPK Project Specialists, Clinical Operations, Data Management, Regulatory Affairs, and Project Managers).

Interact directly with CDE experts for bioanalytical issues when needed. Provide support to CDE inspections and GSK QA audits, and their on-site visits to CRO studies in China.

Engage in the bioanalytical discussion with local community and regulators to enhance GSK profile and influence positive changes in bioanalytical practices in China.

Basic Qualifications:

PhD in Immunology, Biology, Pharmacology, Chemistry, or Analytical Science

Understanding of drug development in the pharmaceutical industry

Prior hands-on experience in at least one bioanalytical technique (LC/MS, Immunoassay, Cellular Assays) and application (PK Bioanalysis, Immunogenicity, Biomarkers).

Experience and knowledge in transferring bioanalytical assays to China to support China or global studies preferred.

Understanding PK Bioanalysis, Biomarker, Immunogenicity and/or cellular assay delivery requirements and technical limitations.

Familiarity with regulatory guidelines from health authorities in China.

Ability to work on cross-functional drug development teams and represent the bioanalytical function, and drive/deliver bioanalytical strategies and commitments to study teams in a matrix environment.

Excellent interpersonal and communication skills. Fluent in written and spoken English and Mandarin.

A strong commitment to learning and being proactive.

GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. Were committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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Benefits of working as a Investigator, Bioanalysis, Immunogenicity and Biomarkers (BIB) China in Dong, Pahang:

Learning opportunities

Advancement opportunities

Attractive package