GSK

Investigator - Immunogenicity Method Development Scientist

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
November 16 2020
Ref
269038
Organization Type
Pharma
GSK has an exciting opportunity available for an enthusiastic and innovative immunologist/cell biologist to join GSK's Immunogenicity group in Collegeville, PA. You will be working in a stimulating and fast-moving environment, where we put great emphasis on high quality science. Within this context and building on GSK's capabilities in biopharmaceutical therapeutics, the role will be within the method development and validation team to optimize, develop, and validate analytical anti-drug antibody (ADA) and neutralizing antibody (NAb) immunogenicity methods for early and late stage clinical development.

As an investigator level scientist, you will have the opportunity to contribute to all facets of the immunogenicity method development and validation analytical workflows. This position will involve the use of laboratory automation, digitized data flows and electronic documentation practices, and the opportunity to continue to progress the science of analytical methods targeting the immunogenicity of novel targets and biopharmaceutical therapeutics in the area of clinical drug development. In this role, you will be supporting progression of our growing drug development portfolio by developing and validating robust immunogenicity analytical methods for clinical drug development.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Independently lead method development, optimization, trouble shooting, and validation of clinical ligand binding anti-drug antibody (ADA) immunogenicity methods for novel targets and biopharmaceutical therapeutics across the GSK drug development portfolio.
  • Developing novel cellular and/or ligand binding neutralizing antibody (NAb) assay methods to support later stage projects.
  • Initiate, develop, and execute scientific research by applying functional knowledge and existing methodologies to solve complex problems.
  • Manage multiple projects concurrently, while adhering to agreed timelines.
  • Ensure that laboratory work is performed to GLP/GCP quality standards and applicable written procedures.
  • Perform quality checks of data, laboratory notebooks, and other scientific documentation as required.
  • 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 academic and industry practices to resolve assay related issues in the area of immunogenicity.
  • Prepare scientific presentations and present work at departmental and/or external meetings as well as the authoring of publications in peer-reviewed journals.
  • Author SOPs, bioanalytical reports, amendments, and other scientific documents to a high-quality standard.
  • Evaluate new platforms/technologies and develop new techniques as needed.
  • Interface with project teams 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.
  • Work with external partners (CROs) as needed to transfer internal assays and provide guidance, troubleshooting and quality oversight.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Master's degree with 5 years' experience, Bachelors degree with 10 years' experience or ideally in industry or new PhD in Immunology, Cell Biology or related discipline.
  • Strong experience and understanding of immunology, cellular and molecular biology gained through research and development experience using immunological techniques.
  • Experience in immunoassay experimental design, execution, assay development and analysis.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD in Immunology, Cellular Biology or related discipline with 2 or more years of experience ideally in industry
  • Experienced and proficient in the optimization and validation of immunogenicity assays, both ligand binding and cell-based immunoassays.
  • Experience in support of clinical analytical immunoassay methods.
  • Experienced and proficient in laboratory automation and digitized documentation using Electronic Laboratory Notebooks (ELNs).
  • Excellent written and verbal communication skills.


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

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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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