Head of Technical

Larimar 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. 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 has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 75 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 (GMPs).
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 and expertise to the development of nomlabofusp and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

This position will be part of the Analytical Sciences Team within the Larimar Technical Operations Group. The person who fills this role should have knowledge in analytical method development, transfer, qualification and QC stability in support of the manufacture of a recombinant fusion proteins expressed in E. coli fermentation systems at Larimar's external manufacturing partners. Generation of internal certificates of analysis, shelf-life letters, and other relevant internal documents.
Review of routine OOS reports, deviations, change controls and QC data generated from External Laboratory partners.
Review of vendor CoA's, data verification for internal CoA's and regulatory filings
Keeps abreast of current regulatory and industry guidelines to support the on-going clinical development and to ensure compliance across multiple regulatory jurisdictions.
Work closely with contract service provider (CSP) Quality Control testing groups to support assay troubleshooting where needed.
Including generation of protocols, data review and statistical analysis of data generated. Draft technical reports to summarize development and assay qualification studies.
Can work in a team environment but can also take ownership of large technical reports and projects.


MS/BS/BA within Biology, Biochemistry, Cell Biology, or related field (Cell Biology, Biology or Biochemistry preferred) and 4 to 8 years' experience required
GxP experience in a Quality Control or Analytical Development laboratory with experience or first-hand knowledge in analytical method development and qualification under ICH/FDA guidelines is required.
Experience working under global regulatory agencies such as the EMA and HC is highly desirable.
Mastery of the Microsoft Office Suite (Word, Excel, PowerPoint) required
Experience working with electronic quality management systems is desired.
Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

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.