Position Summary Larimar Therapeutics is seeking an experienced and highly motivated Analytical Scientist to provide scientific and strategic leadership for analytical development activities supporting a late-stage protein therapeutic. Reporting directly to the Head of Analytical Science and Technology, this individual will be responsible for establishing and executing analytical strategies and overseeing analytical method transfer, validation, and lifecycle management activities at external development and contract manufacturing organizations (CDMOs).
The successful candidate will serve as a key technical leader across Drug Substance (DS) and Drug Product (DP) development, providing scientific oversight for analytical method development, qualification, validation, transfer, and ongoing method performance monitoring. This role will work closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners to ensure robust analytical support throughout product development and commercialization.
The ideal candidate possesses deep expertise in protein therapeutic characterization and analytical control strategies, including hands-on experience with chromatographic, electrophoretic, and mass spectrometry-based analytical techniques used to support process development, release testing, comparability assessments, and stability programs.
This individual will have a demonstrated track record of leading analytical activities for protein therapeutic programs from development through clinical manufacturing, with experience supporting regulatory submissions and health authority interactions. Experience serving in a CMC leadership role, such as Program Team Leader or CMC program Lead, is highly desirable.
Job Duties and ResponsibilitiesAnalytical Development Leadership- Develop and execute analytical strategies to support the development, manufacture, characterization, and commercialization of protein therapeutics.
- Provide scientific leadership and technical oversight for analytical method development, optimization, qualification, validation, transfer, and lifecycle management conducted internally and at contract laboratories.
- Establish phase-appropriate analytical control strategies aligned with ICH guidelines, regulatory expectations, and product-specific risk assessments.
- Lead analytical characterization programs, comparability assessments, forced degradation studies, stability studies, and product specification development activities.
- Review and approve analytical methods, validation packages, technical reports, and supporting documentation ensuring compliance with cGMP and regulatory expectations.
- Author and review SOPs and internal guidance documents to streamline business processes.
- Drive scientific investigations related to analytical method performance, product quality attributes, and process-related changes.
- Lead comparability assessments and critical quality attribute (CQA) evaluations to ensure process changes are appropriately assessed and maintained within established quality parameters.
- Evaluate emerging analytical technologies and recommend approaches to strengthen product characterization and control strategies.
CMC and Program Leadership- Serve as the analytical sciences representative on cross-functional program and CMC teams.
- Provide strategic input to process development, manufacturing, technology transfer, and product lifecycle management activities.
- Lead or contribute to technical risk assessments and resolution of complex product, analytical, and process development challenges.
- Provide oversight of analytical activities executed at CDMOs, contract laboratories, and external development partners.
- Author, review, and approve technical documents, protocols, reports, regulatory filings, and responses to health authority inquiries.
- Support regulatory submissions, agency interactions, inspections, and audit readiness activities.
- Effectively communicate analytical development strategies, risks, and recommendations to internal stakeholders and senior management.
Requirements
RequirementsEducation and Experience- Bachelor's degree in a relevant discipline and 15+ years of relevant professional experience; or
- Master's degree and 12+ years of relevant professional experience; or
- Ph.D. and 8+ years of relevant professional experience.
- Demonstrated experience leading analytical development activities supporting protein therapeutics in a biotechnology or pharmaceutical environment.
- Experience supporting IND, BLA, MAA, or other global regulatory submissions.
- Proven experience working with recombinant proteins, enzymes, fusion proteins, antibody fragments, or other protein-based therapeutics.
- Experience managing analytical development, method transfer, and technology transfer activities at CDMOs and other external development partners.
- Strong understanding of GxP regulations, quality systems, and pharmaceutical development principles.
- Excellent leadership, communication, project management, and stakeholder management skills.
- Ability to operate effectively in a fast-paced and evolving environment.
- Demonstrated commitment to scientific excellence, continuous improvement, and collaborative problem-solving.
Technical QualificationsCandidates should possess hands-on experience developing, troubleshooting and qualifying, analytical methods commonly used for protein therapeutic development, including:
- Size Exclusion Chromatography (SEC)
- Reduced Capillary Electrophoresis Sodium Dodecyl Sulfate (rCE-SDS)
- Non-Reduced Capillary Electrophoresis Sodium Dodecyl Sulfate (nrCE-SDS)
- Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC)
- Ion Exchange Chromatography (IEX), including charge variant characterization
- Peptide Mapping using LC-MS and/or UV detection
Strong understanding of protein structure-function relationships and advanced characterization techniques, including:
- Analytical Ultracentrifugation (AUC)
- Circular Dichroism (CD)
- Differential Scanning Calorimetry (DSC)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Size Exclusion Chromatography with Multi-Angle Light Scattering (SEC-MALS)
- Intact mass and peptide-level mass spectrometry characterization
- Aggregation, fragmentation, oxidation, deamidation, glycation, and other protein degradation pathways
BenefitsLarimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
