Manager, Analytical Sciences, CMC Technical Operations Group (Philadelphia)

The Company:

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. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein, to the mitochondria of patients with Friedreichs ataxia. Friedreichs 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 companys strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their teams 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.

Description

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 Larimars external manufacturing partners. In this fast-paced environment, the person who fills this role will have the opportunity to develop scientifically and gain insight into other areas of the business.

Job Responsibilities

The responsibilities may include, but are not limited to, the following activities:

• 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 CoAs, data verification for internal CoAs and regulatory filings
• Review of Analytical test methods, transfer protocols, qualification protocols and associated reports.
• 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.
• Full understanding of selection, characterization, and maintenance of Reference Standard Program. Including generation of protocols, data review and statistical analysis of data generated. Responsible for generating the reports associated with the program.
• 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.

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