GlaxoSmithKline
Associate Director, LC-MS Bioanalytical External Study Monitor
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - Upper Providence, UK - Hertfordshire - StevenagePosted Date:
Aug 26 2024We’re currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to LC-MS PK and biomarker end points. The role is based in the R&D hub in Upper Providence US.As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSK's studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you work with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio.As a senior BESM, you will manage the bioanalytical support externalized to CRO partners covering method development, assay transfer/validation (including cross validation), and work closely with internal team members to define timeline, outsourcing strategy, develop new processes for outsourcing to better optimize the outsourcing workflow. You will monitor assay performance at CRO and ensure high quality PK and/or biomarker are delivered to pre-agreed project timelines and quality standards. You will contribute to bioanalytical sections in the regulatory submission packages worldwide. You will make recommendations on the CRO selections based on their key performance index (KPI).This role will provide YOU the opportunity to lead key activities to progress YOUR career; these responsibilities include some of the following:The primary deliverables for the LC-MS Bioanalytical External Study Monitor (BESM) group will be to:Contribute to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Provide bioanalytical life-cycle support for all phases of clinical trials, especially late phase assets.Lead bioanalytical projects in line with agreed departmental/project timelines.Act as Sponsor Reviewer (SR) for Bioanalysis and Biomarker Platforms studies and study contributions outsourced to contract research organizations (CROs).Act as the primary interface for communication between GSK and CRO staff.Work closely with CRO partners to ensure timelines for method transfer, validation and sample analysis are met and communicate any delays.In partnership with GSK External QA, evaluate third-party compliance with GLP, GCP Clin. Lab, and worldwide regulations, relevant SOPs, protocols, policies and procedures.Work closely with internal GSK stakeholders to fulfill the requested timeline and data/report delivery.Review and contribute to clinical study reports and assist with the regulatory filing.Interact with Bioanalysis and Biomarker Platforms internal group and manage reference standard and internal standard distribution from Bioanalysis and Biomarker Platforms to CROs and ensure CRO possesses unexpired standards for the conduct of the study.Represent the department in internal project teams and regulatory interactions (questions and filings) related to LC-MS assays.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD or MS in Chemistry, Biochemistry or related discipline, with 5+ years of pharmaceutical industry bioanalysis experience, or BS in Chemistry, Biochemistry, or related discipline with 10+ years of pharmaceutical industry bioanalysis experience.Experience delivering bioanalytical methods (i.e., method development, method validation, troubleshooting, etc.).Pharmaceutical industry regulated bioanalysis experience.Developing and validating methods to support validation of bioanalytical LC-MS assays.Experience preparing analysis and reporting of clinical new chemical entity (NCE) PK, biomarker data and its context to the study/project.GLP, GCLPs, and regulatory guidance experience.Must have represented department at project teams and regulatory interactions (questions and filings).Accomplished data interpretation experience both bioanalytically as well as secondary outputs such as PK/PD.English both spoken and written.Preferred Qualifications:If you have the following characteristics, it would be a plus:Previous study monitoring experience.Experience in mentoring young scientists in a regulated bioanalysis environment.Peer recognition in the pharmaceutical industry by publication at peer review journals and podium/poster presentations at international conferences.Experience of quantitative LC-MS bioanalysis of protein biomarkers.Experience of contributing to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Experience in study setup and management of regulated studies in Thermo Watson LIMS.Experience in tools or software for tracking CRO key performance index and study/schedule plan.Experience of working through contract negotiations with partners and 3rd parties.Excellent communication skills – will need to interface between many functional areas including external suppliers, internal study teams, SMEs, and QA.Excellent attention to detail – reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples.Cultural sensitivity.Willingness to travel if needed.#LI-GSKPlease visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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/AgenciesGSK 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.
#J-18808-Ljbffr
USA - Pennsylvania - Upper Providence, UK - Hertfordshire - StevenagePosted Date:
Aug 26 2024We’re currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to LC-MS PK and biomarker end points. The role is based in the R&D hub in Upper Providence US.As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSK's studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you work with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio.As a senior BESM, you will manage the bioanalytical support externalized to CRO partners covering method development, assay transfer/validation (including cross validation), and work closely with internal team members to define timeline, outsourcing strategy, develop new processes for outsourcing to better optimize the outsourcing workflow. You will monitor assay performance at CRO and ensure high quality PK and/or biomarker are delivered to pre-agreed project timelines and quality standards. You will contribute to bioanalytical sections in the regulatory submission packages worldwide. You will make recommendations on the CRO selections based on their key performance index (KPI).This role will provide YOU the opportunity to lead key activities to progress YOUR career; these responsibilities include some of the following:The primary deliverables for the LC-MS Bioanalytical External Study Monitor (BESM) group will be to:Contribute to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Provide bioanalytical life-cycle support for all phases of clinical trials, especially late phase assets.Lead bioanalytical projects in line with agreed departmental/project timelines.Act as Sponsor Reviewer (SR) for Bioanalysis and Biomarker Platforms studies and study contributions outsourced to contract research organizations (CROs).Act as the primary interface for communication between GSK and CRO staff.Work closely with CRO partners to ensure timelines for method transfer, validation and sample analysis are met and communicate any delays.In partnership with GSK External QA, evaluate third-party compliance with GLP, GCP Clin. Lab, and worldwide regulations, relevant SOPs, protocols, policies and procedures.Work closely with internal GSK stakeholders to fulfill the requested timeline and data/report delivery.Review and contribute to clinical study reports and assist with the regulatory filing.Interact with Bioanalysis and Biomarker Platforms internal group and manage reference standard and internal standard distribution from Bioanalysis and Biomarker Platforms to CROs and ensure CRO possesses unexpired standards for the conduct of the study.Represent the department in internal project teams and regulatory interactions (questions and filings) related to LC-MS assays.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD or MS in Chemistry, Biochemistry or related discipline, with 5+ years of pharmaceutical industry bioanalysis experience, or BS in Chemistry, Biochemistry, or related discipline with 10+ years of pharmaceutical industry bioanalysis experience.Experience delivering bioanalytical methods (i.e., method development, method validation, troubleshooting, etc.).Pharmaceutical industry regulated bioanalysis experience.Developing and validating methods to support validation of bioanalytical LC-MS assays.Experience preparing analysis and reporting of clinical new chemical entity (NCE) PK, biomarker data and its context to the study/project.GLP, GCLPs, and regulatory guidance experience.Must have represented department at project teams and regulatory interactions (questions and filings).Accomplished data interpretation experience both bioanalytically as well as secondary outputs such as PK/PD.English both spoken and written.Preferred Qualifications:If you have the following characteristics, it would be a plus:Previous study monitoring experience.Experience in mentoring young scientists in a regulated bioanalysis environment.Peer recognition in the pharmaceutical industry by publication at peer review journals and podium/poster presentations at international conferences.Experience of quantitative LC-MS bioanalysis of protein biomarkers.Experience of contributing to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Experience in study setup and management of regulated studies in Thermo Watson LIMS.Experience in tools or software for tracking CRO key performance index and study/schedule plan.Experience of working through contract negotiations with partners and 3rd parties.Excellent communication skills – will need to interface between many functional areas including external suppliers, internal study teams, SMEs, and QA.Excellent attention to detail – reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples.Cultural sensitivity.Willingness to travel if needed.#LI-GSKPlease visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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/AgenciesGSK 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.
#J-18808-Ljbffr