Senior Manager/Associate Director of Drug Substance Manufacturing Process Characterization and Process Validation

Description : The Company :

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 :

Senior Manager / Associate Director of Drug Substance Manufacturing Process Characterization and Process Validation within the Larimar Technical Operations Departments

Reports to : Director, CMC Technical Operations

Position Summary :

This position will be part of the Drug Substance Manufacturing Team within the Larimar Technical Operations Group. The person who fills this role should have drug substance (DS) process development (PD), manufacturing (MFG), and process validation (PC / PPQ) that are executed at Larimar's external 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 :

• Oversight of Process Characterization and Process Performance Qualification at CSPs for late stage clinical asset.
• Lead risk assessments, protocol generation / review, scaled down model qualification, process control strategy, PPQ Master plan generation / review, end of production banking, etc. at CSPs
• Authoring and managing continued process verification (CPV), annual updates to INDs, BLAs, annual product reviews (APRs)
• Data entry, data analysis and data trending.
• Communicate between CSP and project managers, quality and regulatory stakeholders, and senior leaders.
• Maintains a good understanding of Regulatory and Quality aspects appropriate to all aspects of work.
• Performing presentations at team, department and project meetings while collaborating with other groups within Larimar.
• Direct intermediate between R&D and contract service providers (CSPs) to take new assets from R&D into first in human clinical trials via right first time, DOE, and QbD development.
• Cross functional contributor with Upstream and Downstream drug substance leads to develop scalable processes based on manufacturing capabilities.
• Opportunity to develop platform process for future assets in conjunction with Upstream and Downstream drug substance leads.
• Managers may assign additional duties as priorities require.

Requirements : Qualifications :

Qualifications :

• PhD / MS / BS in Biochemistry, Chemical Engineering, or related field with a minimum of 10 years of experience in biopharmaceutical industry.
• Hands-on experience working in a cleanroom environment and in drug substance manufacturing of biologics.
• Experience and knowledge in the entire drug substance manufacturing process with upstream and downstream knowledge of E.

coli systems preferred. Must understand fermentation, column chromatography, and TFF.

• GxP experience in a Technical Operations group (Process Development, Manufacturing or Manufacturing Science and Technology, MSAT) in PD or MFG under ICH / FDA guidelines is required.
• Experience working under global regulatory agencies such as the EMA and HC is highly desirable.
• Experience in risk management, deviation, root-cause investigations and CAPAs.
• Experience in writing CMC sections of IND and BLA.
• Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly desired.
• Must be proactive, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
• Excellent communication, organization, and collaborative skills are essential.
• Experience with Microsoft Suite is required, experience with Microsoft teams is desirable.

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 mannerwithout 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.

PI76589f19f92d-26289-34654692