Maisy Yeager

Accomplished Scientist and Project Manager with over 20 years of experience in bioanalysis, DMPK, and the design and execution of preclinical and clinical studies. Proven expertise in LC-MS/MS laboratory design, development, and management, with a strong track record of solving complex analytical challenges and delivering high-quality data to support drug discovery and development. Adept at leading cross-functional teams, managing global projects, and aligning scientific strategies with regulatory and business objectives. Recognized for driving innovation, ensuring compliance, and fostering collaborative environments that accelerate timelines and enhance scientific outcomes.

Longboard Pharmaceuticals    La Jolla, CA                                                             2023 – 2025 

Senior Manager, Bioanalytical Development

Led bioanalytical strategy, managed CROs and academic partnerships to execute preclinical and clinical studies on time and within budget.

Oversaw and outsourced studies, ensuring scientific rigor and regulatory compliance (GxP, FDA/EMA, ICH-M10).

Provided high-level scientific guidance and vendor management for preclinical PK/PD and in vivo efficacy studies.

Liaised with cross-functional teams (CMC, clinical operations, regulatory, legal) and external stakeholders to align project goals and mitigate risks.

Authored and reviewed key regulatory documents, including IND sections, study protocols/reports, and investigator brochures.

HIGHLANDS Consulting    Remote/Onsite for Clients                                                      2020– Present

Bioanalytical Project Director (Consultant)

Provides expert bioanalytical consulting to biopharma clients with a focus on small molecule and biologics bioanalysis.
Directs bioanalytical strategy and manages multiple global projects simultaneously, ensuring compliance with GLP/GCP and ICH-M10 requirements.
Advises on vendor selection and oversees CRO performance, budgets, and deliverables to optimize timelines and cost-efficiency.
Reviews and approves critical study documents (protocols, reports, SOPs) and ensures scientific and regulatory integrity.

EMD SERONO / MERCK KGAA   Billerica Ma / Darmstadt Germany                                      2019 – 2023 

Sr. Bioanalytical Project Manager                                                                  2021 – 2023

Bioanalytical Project Manager                                                                       2019 – 2021

Led bioanalytical operations for small and large molecule programs, including method development, validation, and sample analysis across global CROs.
Directed regulated bioanalytical work supporting Phase I–IV clinical trials and ensured alignment with evolving FDA and ICH guidelines.
Provided SME input for regulatory submissions and responded to agency queries on bioanalytical data.
Managed global outsourcing strategies for bioanalysis and oversaw CRO selection, contracting, and performance.
Monitored assay quality, performed data reviews, and ensured timely delivery of bioanalytical results for decision-making.

Medcomp Sciences    Zachary, LA                                                                                     2017 – 2020

Toxicology Manager / Director Laboratory Operations 

Directed lab operations for high-throughput LC-MS/MS bioanalysis supporting toxicology and clinical testing.
Designed, validated, and implemented quantitative methods to replace legacy platforms and improve efficiency.
Ensured laboratory compliance with CLIA, CAP, and state regulatory requirements.

EARLY EXPERIENCE

Catabasis Pharmaceuticals, Inc    Cambridge, MA    Scientist I                                  2013 – 2016 

Sirtris, A GSK Company    Cambridge, MA    Scientist I                                                   2008 – 2013 

Excellence in Science Award – DBS Development & Implementation)Spearheaded the development and validation of DBS (dried blood spot) for nonclinical small molecule analysis, reducing animal use by 85% and compound consumption by 80%.

BioSero, Inc    San Diego, CA     Senior New England Account Manager                              2007 – 2008 

Synta Pharmaceuticals    Lexington, MA    Research Associate                                     2004 – 2007

Galactic Halo Award – Dose Formulation Validation in Watson

Beckman Coulter Inc (Peoples Genetics)   Woburn, MA    Scientist                         2002 – 2004 

Variagenics, Inc    Cambridge, MA    Research Associate                                                    2001 – 2002 

Collagenesis, Inc    Beverly, MA    Process Technician II                                                  2000 – 2001 

Toxikon Corporation, Inc    Bedford, MA    OE / Wet Chemistry Analyst       2000 

Associate of Science: Science   Luzerne County Community College

Bachelor of Science: Marine Biology and Ecology   Millersville University of Pennsylvania