Manager/Sr. Manager of Analytical Sciences

We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases. At Larimar, we embrace everyone's contribution to our Mission. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!
We are a 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, 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.
We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and about 40 employees. Our 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).
Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.
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 the assay development, transfer, qualification, routine QC performance (inclusive of stability) in support of the manufacture of recombinant fusion proteins expressed in E. coli fermentation systems at Larimar's 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.
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 LIR's, deviations, change controls and QC data generated from External Laboratory partners and move documents through our internal systems for storage and archiving.
• Review of vendor CoA's, data verification for internal CoA's and regulatory filings[KLJ1] [UP2]
• Review of Analytical test method, transfer protocols, qualification protocols and associated reports.
• Keeps abreast of current regulatory and industry guidelines for the development of our Chemistry Manufacturing and Controls (CMC) packages.
• Perform statistical analysis of data to understand trends and identify next steps in assay development in a Phase appropriate manner.
• 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.
• Assist in the planning, initiation, qualification, re-qualification and review of Reference Standards.
• Assist in the development of a two-tiered Reference Standard program as needed.
• Manage all the inbound communications from the vendors and distribute those documents for review to the relevant team members.
• Draft technical reports to summarize development and assay qualification studies.
• Can take on new and sometimes ambiguous challenges and learn quickly.
• Can work in a team environment but can also take ownership of large technical reports and projects.
• Have development experience in cell-based potency assays or ELISA.
• Have experience with developing and troubleshooting potency assays for testing in a GMP environment.

Requirements
To be considered for this position you must have a MS/BS/BA within Biology, Biochemistry, Cell Biology, or related field and 4 to 8 years' experience. GxP experience in a CMC group (QC/Analytical Development) and 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. Experience with binding assays, cell-based potency assays, and ELISA testing preferred. The level is determined based on qualifications relevant to the role.

• Have working knowledge of Microsoft Suite (Word, Excel, PowerPoint) and SoftMax.
• Understand and working knowledge -of statistical software such as JMP.

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.