Principal Scientist, Bioanalyst

    • Waltham, MA

Site Name: USA - Massachusetts - Waltham
Posted Date: Jun 19 2020
Do you have the passion to join a group whose mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.

Your Impact at GSK:

The Bioanalytical Principal Scientist is accountable for timely and effective bioanalytical support for projects in preclinical and clinical development and for marketed products support. The incumbentwill be responsible for the establishment of bioanalytical assays principally forbiopharmaceuticalsfrom early research programs right through to clinical trials. They areexpected to demonstrate competency in setting up bioanalytical assays, interpreting bioanalytical data, development and implementation of strategic plans for nonclinical and clinical development, as well as providing scientific expertise and guidance to project teams and management. This individual will be highly analytical, decisive, goal-oriented, and timeline-sensitive while maintaining the highest of scientific and ethical standards. The Principal Scientist will actively participate on project/product teams, as well as collaborating with research unit teams. The incumbent will adhere to established processes, policies and quality systems for outsourcing, managing and reporting regulatory programs, studies and other activities in support of GSK portfolio projects and to provide appropriate content and submission-ready documentation for the bioanalytical components of regulatory submissions. The bioanalytical scientists work closely with other functions within the nonclinical development area (toxicology, DMPK) as well as the clinical pharmacology, translational R&D and pharmaceutical development groups to support candidate molecules.

Job Responsibilities:

  • To be part of a team that is responsible for interfacing with key customer groups to deliver bioanalytical assays for early research programs right through to clinical trials.
  • Provide high-level advice to project/product teams and senior management, including evaluation of conclusions and potential impact of bioanalytical study results on projects and clinical/regulatory strategy.
  • Participate as a functional representative in research and development project teams providing bioanalytical input andhelping to define objectives and development strategies. In particular to define nonclinical and clinical assay specifications and ensure implementation in support of project goals.
  • Enable and manage a CRO provider vendor network to develop and deliver relevant bioanalytical assays for pharmacokinetics, immunogenicity and biomarker assessments to support nonclinical and clinicalbiopharmaceuticalsprograms.Coordinate all activities (selection, CDAs, service agreements, contract negotiation, protocols, study reports) with selected CROs.
  • Contribute to the appropriate sections of regulatory submissions and other documents (e.g. nonclinical reports, clinical protocols, INDs, CTAs, NDAs, MAAs),participate in the advisory board meetings and provide well delivered and accurate oral and/or written data presentations to the regulatory agencies.Ensure relevant GxP compliance.
  • Monitor and interpret bioanalytical studies and communicate critical and significant study results. Lead discussions and decisions related to bioanalytical assessment for each candidate and define the appropriate messaging associated with written documentation of such assessments.

Basic Qualifications:
  • PhD in a bioanalysis-related area with at least 5 years' experience within the pharmaceutical industry.
  • Bachelor of Science/Master of Science with at least 10 years of pharmaceutical industry experience will also be considered.
  • Experience with technical and regulatory aspects of bioanalytical testing in support of research and development including experience working with global regulatory agencies and knowledge of the regulatory requirements for nonclinical and clinical packages e.g. IND/CTA, IMPD, MAA/NDA/BLA, and guidelines e.g. GLP, GCP, ICH.
  • Experience within a team environment as both a member and a scientific lead.
  • Hands-on experience in all aspects of bioanalytical study conduct including study set up, sample receiving, assay validations, sample analysis and data reporting.
  • Background in protocol writing, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Experience in the outsourcing and external oversight of nonclinical and clinical bioanalytical studies conducted by qualified suppliers.
  • US Work authorization is required. Sponsorship is not available.

Preferred Qualifications :
  • A focus on biopharmaceuticals bioanalysis, immunogenicity and biomarker assessment is preferred.
  • Ability to creatively seek resolutions to scientific issues that arise during development of new biopharmaceutical therapeutics especially within a cross-functional team environment.
  • Good organizational and interpersonal skills including oral and written communication skills.
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
  • Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.
  • Ability to effectively engage with a wide variety of internal/external technical and business experts.

Please use the cover letter to highlight how you meet the competencies for the role. Your cover letter along with your CV will be used to assess your application. Thanks for your interest in this opportunity.

Why GSK?
Our values and expectations are 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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