Principal Scientist / Senior Principal Scientist, Bioanalytical Lead | Drug Metabolism & Pharmacokinetics

Principal Scientist / Senior Principal Scientist, Bioanalysis Bioanalytical Lead | Drug Metabolism & PharmacokineticsNote: Level will be commensurate with experience, skill set, and qualifications.What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?ABOUT PIONEERING MEDICINESPioneering Medicines, Flagship Pioneering’s in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship’s innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship’s bioplatform companies. Within Flagship’s Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners’ R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.About the RoleWe are looking for a highly skilled and motivated scientist to join our DMPK team as the Bioanalytical Lead at the Principal Scientist or Senior Principal Scientist level. This role will be responsible for leading and executing bioanalytical strategies across our drug discovery and development portfolio, spanning small molecules, peptides, and biologics. Given that 100% of our bioanalytical work is outsourced, the ideal candidate must have strong CRO management experience and the ability to oversee and drive high-quality outsourced bioanalytical programs. In addition to bioanalytical leadership, this individual will also be expected to serve as operations lead for ADME and PK studies as needed. The ideal candidate brings deep expertise in LC-MS/MS bioanalysis, a strong working knowledge of ligand binding assays and immunogenicity assessment, and the ability to manage complex operational activities across multiple concurrent programs.Key ResponsibilitiesScientific & BioanalyticalLead bioanalytical strategy and execution for non-GLP and GLP PK, TK, and clinical studies across small molecule, peptide, and biologic programsDevelop, qualify, and validate LC-MS/MS methods for small molecules and peptides in biological matricesDevelop and validate LBA/hybrid LC-MS methods for biologics including PK and ADA assaysServe as the Clinical Bioanalytical Lead for assigned programs, including oversight of method transfer to clinical CROs and clinical laboratoriesProvide scientific and strategic bioanalytical guidance to cross-functional program teams and platform companiesCollaborate with DMPK, Clinical Pharmacology, Toxicology, and CMC teams to ensure integrated bioanalytical supportContribute to regulatory submissions including IND filing and clinical study reportsSupport development and implementation of innovative bioanalytical tools and workflows including digital and AI/ML-based solutionsCRO & Outsourcing ManagementManage all outsourced bioanalytical activities across 100% externally executed portfolio serving as the primary scientific and operational interface with CROsIdentify, evaluate, and qualify CRO partners for bioanalytical services including LC-MS/MS, LBA, hybrid LC-MS, and immunogenicity assaysOversee CRO study execution, data quality, timelines, and deliverables to ensure alignment with program requirements and regulatory standardsCoordinate with legal and finance on CDAs, MSAs, SOWs, and POs with CROs and external partnersManage vendor relationships, performance metrics, and issue resolution across the CRO networkOperational & Portfolio ManagementCoordinate and manage DMPK operational activities across the entire internal and partnered portfolio including PK, ADME, BA, and immunogenicity studiesServe as operations lead for ADME and PK studies as needed, in addition to primary bioanalytical responsibilitiesManage study scheduling, sample management, material shipment, handling, and logistics across multiple concurrent programsTrack and manage program timelines, deliverables, and budgets to ensure continuity across the portfolioSupport development and maintenance of DMPK operational tools, databases, and automated workflows to drive efficiencyQualificationsPhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or related field with 8+ years of industry experience (Principal Scientist), or 10+ years of industry experience (Senior Principal Scientist); or MS with 15+ years of relevant experienceDeep expertise in LC-MS/MS bioanalysis for small molecules and peptidesStrong working knowledge of LBA platforms (MSD, ELISA) and hybrid LC-MS methods for biologicsExperience with GLP bioanalytical method validation per FDA/EMA guidanceProven experience managing outsourced bioanalytical programs and CRO relationshipsExperience supporting clinical bioanalysis and method transfers to clinical CROsDemonstrated ability to manage complex operational activities across multiple programs simultaneously in a fast-paced environmentStrong organizational skills with experience coordinating legal and financial documentation including CDAs, MSAs, SOWs, and POsFamiliarity with immunogenicity assay strategy and ADA method development is a plusExcellent communication and cross-functional collaboration skillsPreferred QualificationsExperience with both non-GLP and GLP studies across discovery through IND-enabling and clinical stagesExperience working in a biotech or drug discovery environment supporting multiple internal and partnered programs simultaneouslyExperience serving as operations lead for ADME and/or PK studiesExperience with AI/ML tools to drive efficiency and innovation in bioanalysis and DMPK operationsAbout FlagshipFlagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble the capital to allow them to take courageous leaps in human health, sustainability, and beyond.What sets Flagship apart is our ability to advance biotechnology by uniting life science innovation, company creation, and capital investment under one roof in a way that is largely without precedent. Our team of scientists, entrepreneurial leaders, and professional capital managers are each aligned around an institutionalized process that enables us to innovate and create breakthroughs for the benefit of people and planet. Many of the companies Flagship has founded have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company’s annual list of the World’s Most Innovative Companies.At Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.Privacy Notice for Applicants: When you apply for a role at Flagship Pioneering or one of its portfolio companies, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact privacy@flagshippioneering.com.