Director, Quality (GMP)

Larimar Therapeutics

  • Bala Cynwyd, PA
  • Permanent
  • Full-time
  • 3 days ago
Description:The Company:Larimar Therapeutics Inc. (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. 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:Director, Quality (GMP)Reports to:Senior Director, QualityLocation:This position is based in the Bala Cynwyd, PA office. This role can maintain a flexible hybrid schedule, but is expected to be in the office on a regular basis to be determined with the hiring manager.Position Overview:The Director, Quality (GMP), will play an integral role in the Quality organization, focusing on quality and compliance support for the manufacture and distribution of Larimar's products. This position will provide quality oversight of contract manufacturing organizations (CMOs) and service providers providing product manufacturing, packaging and labeling, and distribution for clinical development and future commercial use in various regions of the world. The Director, Quality (GMP) will be responsible for managing release of Larimar's products domestically and internationally.Key Responsibilities:
  • Manages the GMP quality team to support the GMP manufacturing of Larimar's products.
  • Provides quality oversight for activities at drug substance, drug product, and supply chain CMOs, including routine product manufacturing (formulation, fill/finish, lyophilization), release and stability testing, technology transfer, process performance qualification, validation, packaging, labeling and distribution activities.
  • Leads internal and external teams to solve quality problems and ensure compliance in product manufacture and distribution.
  • Performs quality review of GMP documentation, including manufacturing batch records, deviations and investigations, change controls, specifications, analytical method and validation documents, stability protocols and reports, etc.
  • Conducts timely release of drug dosage forms for global clinical trials and future commercial use.
  • Oversees/leads the execution of external audits of drug manufacturing and supply chain CMOs and assists in vendor monitoring reviews.
  • Manages Quality/QP Agreements with contract manufacturing and testing partners.
  • Manages completion of internal change controls, deviations and CAPAs associated with product manufacturing, testing and distribution.
  • Creates and revises SOPs and other controlled documents, as needed.
  • Assists in inspection readiness preparation and directly supports regulatory agency inspection(s).
  • Compiles information for regulatory submissions and conducts quality reviews and audits of regulatory submissions, as requested.
  • Supports other Quality programs/activities, as assigned.
  • Approximately 15-20% travel required.
Requirements:Qualifications:This role requires a Bachelor's degree in life sciences with a minimum of 10+ years experience in a Quality role supporting biopharmaceutical manufacturing operations, including 6-8 years of experience in quality management and leadership positions. This role also requires at least 6 years supporting aseptic/sterile formulation, filling, freeze drying, and visual inspection activities in a GMP environment. Thorough knowledge of GxP systems, quality principles, aseptic processing requirements, GMP/GDP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH), and ability to translate understanding to practice is also required. The successful candidate must consistently demonstrate exemplary leadership, communication, and collaboration. They must also possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment. Experience with audit and oversight of CMOs and with regulatory authority inspections is strongly desired.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.PIb8ef3e609c13-9798

Larimar Therapeutics