Director, Quality Control

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NewAmsterdam Pharma Corporation

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2019

🧬 Biotechnologie

💊 Pharmazie

💰 €175.300.000 Post IPO equity im 2024-03

Biotechnology • Pharmaceuticals

NewAmsterdam Pharma Corporation ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung von Therapien für Herz-Kreislauf-Erkrankungen und andere lipidspezifische Erkrankungen konzentriert. Das Unternehmen entwickelt Obicetrapib, einen CETP-Inhibitor, sowie andere Programme, um LDL-C zu senken und das kardiovaskuläre Risiko für Patienten zu reduzieren, die trotz bestehender lipidsenkender Behandlungen ungedeckte Bedürfnisse haben. NewAmsterdam legt Wert auf wissenschaftlich fundierte Entwicklung, klinische Studien und patientenorientierte Initiativen.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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