Director, Quality CMC

6 days ago

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Sabin Vaccine Institute

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Healthcare Insurance • Biotechnology • Non-profit

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

51 - 200 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🤝 Non-profit

💰 $35M Grant on 2023-01

📋 Description

• Quality CMC lead and support for all technical transfer and onboarding of new US-based drug product Fill/Finish site(s) for drug product. • Quality CMC lead and support for all technical transfer and onboarding of new US-based drug substance manufacturing sites • Provide Quality leadership in area(s) of expertise to potentially include cell line development, cell culture, purification, formulation development, analytical development and characterization, drug substance manufacturing and final drug product manufacturing • Ongoing assessment and evaluation of GXP service providers to ensure regulatory compliance. • Departmental lead for monitoring testing and inspection of materials and products by contract service providers to ensure identity, strength, purity and quality is maintained • Participate in internal and external audits/ inspections including other quality assurance assigned activities • Assist in development and implementation of quality system to identify, initiate and monitor corrective and preventive actions to support developmental and regulatory activities • Quality CMC lead to manage, create and review CMC SOP’s and documentation as required • Other duties as assigned

🎯 Requirements

• Bachelor’s degree in a scientific field; master’s degree a plus • 12+ years relevant experience, preferably in GXP quality assurance/quality control roles and with broad CMC drug substance/drug product, analytical/bioanalytical method exposure, quality system development and quality incident management • Biologics product experience: strong knowledge of vaccine development preferred • Demonstrated computerized systems competence, including experience with databases, electronic quality management systems and Microsoft Office • Advanced problem-solving abilities and decision-making skills • Excellent communication skills, including strong writing abilities • Strong interpersonal skills; excellent at building productive working relationships with R&D team members and external collaborators • Experience in project execution using virtual platforms (e.g., Zoom/MS Teams) • Strong attention to detail, ability to manage complex tasks; highly organized, flexible, dependable and able to prioritize competing demands in order to meet deadlines • Thrive in entrepreneurial, team-oriented work environments; experience working with cross-functional teams • Ability to travel domestically and internationally as demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions • Ability to work independently with minimal direct oversight

🏖️ Benefits

• Medical • Dental • Vision • Flexible Spending Accounts • Employer paid Life and Disability insurance • 11 paid holidays with winter break between Christmas and New Years • Employer match on 401(k)