Manager - Senior Manager, CMC Analytical Sciences

Job not on LinkedIn

June 20

Apply Now

Receive Emails with Similar Jobs

Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

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

• Reports to: Director, CMC Analytical Sciences • Location: Remote Work • Why Sabin: Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. • Position Summary: The Manager/Senior Manager, CMC Analytical Sciences provides technical support and expertise in Chemistry, Manufacturing, and Controls (CMC) analytics and method development. • Responsibilities: Management and oversight of method development, qualification, verification, validation and transfer activities at outside testing labs and CDMOs providing testing services. • Technical support and troubleshooting of analytical methods.

🎯 Requirements

• Minimum bachelor’s degree in analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science field. • Advanced degree highly desired. • Minimum of 7 years of direct experience with CMC analytical development. • Minimum of 5 years of direct experience with method validation and transfer. • Hands-on analytical method development experience. • SME-level experience in any of the following: HPLC/UHPLC, titer methods, ELISA impurity methods, cell-based methods, potency methods, infectivity methods, compendial methods, excipient quantitation, RT-PCR, laser light scattering. • Method qualification, verification, and/or validation experience. • Method transfer experience. • Knowledge of current good manufacturing practices (cGMP). • Experience in corrective/preventive action implementation. • Ability to troubleshoot methods remotely. • Successful experience in a collaborative team environment across multiple technical functions and geographical regions. • Strong technical communication and organizational skills. • Ability to work independently with minimal direct oversight and also collaboratively with globally distributed team members. • Ability to work remotely and travel up to 20% (USA and international) to support onsite activities at outside test labs (OTLs) and CDMOs.

🏖️ Benefits

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