Associate Director / Director Of Bioanalysis

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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 Bioanalysis

Job 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

• M.S. (with 10+ years relevant industry experience) or Ph.D. (with +3 years relevant industry experience) in Analytical Chemistry, Biochemistry, or a related field.

• 3+ years experience in bioanalytical research and development within the biopharmaceutical industry.

• Demonstrated expertise in bioanalytical method development, validation, and sample analysis, particularly in quantitative LC-MS/MS applications of biomolecules in complex biological matrices.

• Strong understanding of regulatory requirements for bioanalytical methods and sample analysis (e.g., FDA, EMA, ICH guidelines).

• Exceptional communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels of the organization.

• Excellent problem-solving skills, attention to detail, and ability to work independently or as part of a team.

• Effective communication skills, with the ability to present scientific findings and recommendations to diverse audiences.

Preferred Qualifications:

Recent hands-on laboratory experience in immunoaffinity-LC-MS/MS platform for quantitative analysis of proteins.

Benefits:

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.