GSK

Investigator - Immunogenicity

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
October 26 2020
Ref
268844
Organization Type
Pharma
We have an exciting opportunity for a highly motivated, agile and experienced scientist with laboratory expertise in immunology to join the Immunogenicity group within the Bioanalysis, Immunogenicity and Biomarkers (BIB) organization at GSK.

The successful applicant will be responsible for generating immunogenicity risk assessment, devising and supporting the immunogenicity analytical strategy through internal and external sample testing, negotiating timelines with clinical teams, contributing to data interpretation and regulatory submissions. Additional responsibilities may include assay development, validation, and testing of non-clinical and clinical samples to support GSK pipeline across therapeutic areas.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Interface with project teams directly to translate immunogenicity needs to relevant assay and sampling parameters from discovery through development
  • Author immunogenicity risk assessments, contribute to IND and IB documents and author integrated summaries of immunogenicity (ISI) components for therapeutic filings
  • Contribute to clinical study design and clinical study reports
  • Work with external partners (CROs) to transfer internal assays and provide guidance, troubleshooting and quality oversight
  • Review assay results in a timely manner. Ensure smooth transfer of results to data management and other business partners and participate in evaluation and interpretation of the immunogenicity data
  • Ensure that laboratory work is performed to GLP/GCP quality standard, and according to applicable written procedures
  • Author SOPs, bioanalytical reports, amendments, and other technical documents to a high scientific standard
  • Review and collate information from relevant sources (including scientific literature, in-house databases, internal experts, conference proceedings, external collaborators, and commercial vendors) to develop knowledge of current practices in the area of immunogenicity
  • Evaluate new platforms/technologies and develop new techniques as needed
  • Prepare scientific presentations and present work at departmental or external meetings
  • Perform quality checks of data, laboratory notebooks, and other documents as required
  • Demonstrate ability to handle multiple projects concurrently, while adhering to agreed timelines


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD in Immunology or other relevant field with 2-5 years of experience
  • Strong scientific background with experience and fundamental understanding of immunogenicity assay development and validation


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Highly motivated team player with a proactive attitude, excellent organizational skills and a demonstrated ability to interact effectively within a multi-disciplinary team
  • Attention to detail with excellent communication and documentation skills
  • Extensive experience with development, optimization and validation of immunoassays across different platforms
  • Familiarities with immunogenicity assessment of novel therapeutic modalities, such as cell and gene therapies.
  • Experience with authoring and preparation of immunogenicity risk assessments, integrated summary of immunogenicity (ISI) and other regulatory documents.
  • Previous experience with managing and oversight of contract research organizations (CROs)
  • Use of Watson LIMS and Hamilton/Tecan (automation)


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness

*LI-GSK

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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