Director, Quality Control

🕒 Abril 15

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NewAmsterdam Pharma Corporation

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🧬 Biotecnologia

💊 Farmacêutico

💰 $175.300.000 Post IPO equity em 2024-03

Biotechnology • Pharmaceuticals

A NewAmsterdam Pharma Corporation é uma empresa biofarmacêutica em estágio clínico, focada no desenvolvimento de terapias para doenças cardiovasculares e outras condições relacionadas aos lipídios. A empresa está avançando com o obicetrapib, um inibidor de CETP, e outros programas destinados a reduzir o LDL-C e diminuir o risco cardiovascular para pacientes que têm necessidades não atendidas, apesar dos tratamentos redutores de lipídios existentes. A NewAmsterdam enfatiza o desenvolvimento baseado em ciência, ensaios clínicos e iniciativas focadas no paciente.

Descrição

• Responsible for managing the Quality Control tasks and reports into the NAP Quality Team. • Review CMO QC laboratory operations, ensuring compliance with regulations such as FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines. • Support analytical development in a quality role; ensuring data integrity; creating, reviewing and approving technical documents (such as stability reports, method validation and method verification protocols and reports and final analytical release data). • Analyze data and metrics relate to quality control to identify trends, patterns, and areas for improvement. • Establish and maintain relationships with suppliers and vendors to ensure compliance with quality control standards. • May be a subject matter expert for regulatory submissions and inspections related to Quality Control tasks and data.

🎯 Requisitos

• Bachelor's degree in a Chemistry or similar scientific discipline, advanced degree preferred • 8-10 years in the pharmaceutical industry working in QC • Strong understanding of analytical testing methods and records • Deep understanding of GxP standards, policies, and procedures (domestic and international) • Experience and strong understanding of small molecule drug substance and non-sterile oral solid dosage drug product testing • Experience working with CDMO/Contract manufacturing and contract laboratories. • Excellent verbal and written communication skills • Collaborative problem-solver, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations • Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision • Ability to travel domestically and internationally, approx. 10-15% of the time • Proficiency is using quality control tools and software, such as statistical analysis software, quality management systems and AI.

🏖️ Benefícios

• Health insurance • Dental and vision coverage • Term life and disability coverage • Retirement plans • Stock option awards