Principal Scientist Bioanalyst

Site Name: USA - Massachusetts - Waltham
Posted Date: Feb 5 2020
Principal Scientist, Bioanalytical Scientist (Biopharmaceuticals)

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-TESARO:
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 incumbent will be responsible for the establishment of bioanalytical assays principally for biopharmaceuticals from early research programs right through to clinical trials. They are expected 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 and helping 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 clinical biopharmaceuticals programs. 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.

Requirements:
  • PhD in a relevant subject with 5-10 years industry-related experience in Research and Regulatory working within the pharmaceutical industry that includes a deep technical and regulatory understanding of bioanalytical testing in support of research and development focusing on biopharmaceuticals bioanalysis, immunogenicity and biomarker assessment. MS with relevant industry experience will also be considered.
  • Proven ability to creatively seek resolutions to scientific issues that arise during development of new biopharmaceuticals therapeutics especially within a cross-functional team environment.
  • Hands-on experience in all aspects of bioanalytical study conduct including study set up, sample receiving, assay validations, sample analysis and data reporting.
  • Experience representing function to global regulatory agencies in support of submissions at all stages of development, i.e. IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Extensive experience in the outsourcing and external oversight of nonclinical and clinical bioanalytical studies conducted by qualified suppliers.
  • Experience within a team environment as both a member and a scientific lead with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to effectively engage with a wide variety of internal/external technical and business experts.
  • 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.

GSK-TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

*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.

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.


Back to top