Associate Director / Director of Bioanalysis
Company: Larimar Therapeutics
Location: Bala Cynwyd
Posted on: May 7, 2024
|
|
Job Description:
Description: The Company:Larimar Therapeutics Inc. is a publicly
held clinical-stage biotechnology company focused on developing
treatments for patients suffering from complex rare diseases using
its novel cell penetrating peptide technology platform. Our lead
product candidate, Nomlabofusp (CTI-1601), is a subcutaneously
administered, recombinant fusion protein intended to deliver human
frataxin (FXN), an essential protein to the mitochondria of
patients with Friedreich's ataxia. Friedreich's ataxia is a rare,
progressive, and fatal disease in which patients are unable to
produce sufficient FXN due to a genetic abnormality. We have
assembled an experienced management team, each of whom has over 20
years of pharmaceutical industry experience. Our management team,
employees, and consultants have significant expertise in discovery,
nonclinical and clinical development, regulatory affairs,
manufacturing and CMC. Our company's strategy is to become a leader
in the treatment of rare diseases by leveraging our
cell-penetrating technology platform and applying our team's
know-how to the development of Nomlabofusp and ourpipeline
projects. We are best characterized by entrepreneurial and
scientific leadership and a participatory workforce committed to
success.Position:Associate Director/Director of BioanalysisJob
Responsibilities:Position Overview:We are seeking a highly skilled
Bioanalytical Expert to oversee PK, PD, Immunogenicity, and
Biomarker assay development, validation, and study phase
bioanalysis for our large molecule drug discovery and development
programs. The successful candidate will be responsible for
designing, executing, and interpreting bioanalytical assays to
support non-clinical and clinical studies primarily through the
effective communication and management of experimental conduct with
external CROs. The Director role may also have the opportunity to
build internal laboratory capabilities to support bioanalytical
assay development and discovery bioanalysis. This role offers the
opportunity to develop expertise in a variety of assay platforms
while working in a dynamic and collaborative environment to
accelerate the development of innovative therapies for rare
diseases.Key Responsibilities:Establish and maintain strong
relationships with external partners, including contract research
organizations (CROs) and academic collaborators, to enhance our
bioanalytical capabilities and expand our scientific
network.Design, optimize, and oversee bioanalytical assays to
measure protein drug concentrations, immunogenicity, and biomarkers
(e.g. gene expression profiles and lipidomics).Develop and validate
analytical methods in accordance with regulatory guidelines and
industry best practices.Manage sample analysis using a variety of
analytical techniques, including liquid chromatography-mass
spectrometry (LC-MS/MS) for large molecules (proteins, lipids),
ligand binding assays (LBA), cell-based assays, RT-qPCR, Nanostring
nCounter , and other biochemical assays.Analyze and interpret
experimental data, troubleshoot assay performance issues, and
provide scientific insights to CROs and project teams.Communicate
effectively and collaborate cross-functionally with colleagues in
research, development (e.g. PK/PD, biostatistics, non-clinical &
clinical operations) and regulatory affairs to support drug
discovery and development programs.Author/contribute to
bioanalytical reports and ensure accurate records of experimental
procedures, results, and conclusions in compliance with regulatory
requirements.Requirements:
PI6ac5-
Keywords: Larimar Therapeutics, Philadelphia , Associate Director / Director of Bioanalysis, Executive , Bala Cynwyd, Pennsylvania
Click
here to apply!
|