Associate Director, Analytical Quality

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.

Job Responsibilities:

The Associate Director, Analytical Quality will play a key role in the Quality organization, focusing on quality and compliance support for analytical activities and services associated with testing, manufacture, and distribution of Larimar's products. This position will provide quality support to contract development manufacturing organizations (CDMOs), contract manufacturing organizations (CMOs), and service providers conducting analytical testing of manufactured products at various stages of the supply chain for clinical development and future commercial use in various regions of the world. This role reports to the Director, Quality (GMP).

Key Responsibilities:

Will include but are not limited to: Provides quality oversight for analytical activities associated with cell bank (master and working), drug substance, and drug product for both clinical development and future commercial use at contract vendors in support of release and stability testing, technology transfer, process performance qualification, and validation activities. Supports quality system monitoring reviews both internally and externally. Performs quality review/approval of GMP documentation, including specifications, analytical method and validation documents, stability and testing-related protocols and reports, Certificates of Analysis (CoA), deviation investigations, CAPAs, change controls, etc. Provides quality input, support, and approval of Out-of-Specification (OOS) and Out-of-Trend (OOT) deviation investigations, excursion events, product quality complaints, etc. Supports the company's vendor qualification program, including participating in GxP audits as a Subject Matter Expert to qualify and to ensure laboratory compliance with cGMP, ICH, and FDA and EU regulations, with a focus on data integrity, method validation, and Out-of-Specification (OOS) and Out-of-Trend (OOT) oversight. May oversee/lead the execution of external audits of vendors performing analytical services/testing activities. Manages implementation/ensures compliance of quality agreements with contract labs/testing partners performing analytical services. Creates, revises, and/or reviews and approves SOPs, Work Instructions, and other controlled documents as needed. Supports the document management and training system. Works with internal and external teams to assist in solving quality problems and ensuring compliance. Assists in inspection readiness preparation and may directly support regulatory agency inspection(s). Supports other Quality programs/activities, as required. Approximately 10-15% travel required.

Requirements:

Qualifications:

Bachelor's degree in life sciences with a minimum of 8+ years experience in a Quality Assurance/Quality Control role supporting GMP Analytical/Stability departments within a biotechnology or pharmaceutical environment In-depth understanding of GxP systems and quality principles, and the ability to understand global regulations and guidance documents and translate understanding to practice is also required Demonstrated ability to initiate process improvements and take initiative is required Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment Experience with deviation investigations, change controls, and/or product quality complaints a plus

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.