Manager, Analytical Development and Quality Support

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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 (formerly referred to as 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. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company’s strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team’s know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position Summary The Manager, Analytical Development and Quality Support is responsible for supporting the execution and oversight of analytical activities for the development and commercialization of protein therapeutics. This role requires a scientifically driven individual with hands-on experience performing and interpreting analytical methods commonly used for biologics stability assessment and quality control testing. Reporting directly to the Head of Analytical Science and Technology, the successful candidate will work closely with internal technical teams and external contract development and manufacturing organizations (CDMOs) to oversee stability programs, review analytical data, verify testing results, and support regulatory-quality documentation. The position requires strong technical expertise, attention to detail, excellent communication skills, and familiarity with GMP-regulated environments.

Key Responsibilities: Analytical and Stability Program Support

• Serve as a technical liaison with CDMOs and contract testing laboratories.
• Coordinate and oversee product stability studies, including protocol execution, sample management, testing schedules, data trending, and reporting of stability results.
• Review and interpret analytical data to support product development, process characterization, comparability assessments, and product stability.
• Review analytical protocols, reports, raw data summaries, Certificates of Analysis (CoAs), and data packages generated by external laboratories to ensure completeness, accuracy, and compliance with specifications and GMP requirements.
• Evaluate analytical investigations, deviations, out-of-specification (OOS) results, change controls, and technology transfer activities associated with outsourced testing.
• Prepare and maintain Certificates of Analysis (CoAs), specification sheets, analytical summaries, and other quality documentation.
• Compile, organize, analyze, and trend analytical data from multiple sources to support development, quality, regulatory, and product lifecycle activities.
• Collaborate with Quality, Process Development, Manufacturing, Regulatory Affairs, and external partners to support analytical strategies and product lifecycle activities.
• Participate in technical discussions regarding analytical methods, product quality attributes, stability trends, and testing strategies, and communicate findings through reports, presentations, and cross-functional meetings.

Requirements

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or a closely related scientific discipline.
• Minimum of 4 years of experience in a Quality Control (QC), Analytical Development, Process Development, or related laboratory environment supporting biopharmaceutical products.
• Hands-on experience executing analytical methods used for protein therapeutic development, release, stability and characterization analysis.
• Experience working within GMP-regulated environments.
• Experience reviewing laboratory data, technical reports, and analytical documentation.

Preferred Technical Experience

• Experience with one or more of the following analytical techniques is highly desirable:
• Size Exclusion Chromatography (SEC-HPLC/UPLC)
• Reversed Phase HPLC (RP-HPLC)
• Ion Exchange Chromatography (IEX)
• Capillary Electrophoresis (CE-SDS, icIEF)
• Protein concentration determination methods such a SoloVPE
• Endotoxin and bioburden testing
• Aggregation and purity assessments
• Stability-indicating analytical methods

Competencies

• Strong understanding of protein therapeutics and biopharmaceutical analytical testing.
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to review, interpret, and critically evaluate complex analytical datasets.
• Demonstrated ability to manage multiple priorities in a fast-paced environment.
• Effective collaborator with internal and external stakeholders.
• Proficiency with Microsoft Office applications and electronic data management systems.

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.