Senior Manager, CMC Technical Operations

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $135k - $165k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

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.

📋 Description

• Support the orderly progression of Sabin vaccine products from clinical stage through validation, marketing authorization, and commercial lifecycle management • Support the CMC Product Champion across CMC functions and external manufacturing and development partners • Serve as a cross-functional matrix team member integrating CMC efforts for vaccine candidates • Collaborate with internal and external CMC functional areas to execute projects and deliver results on time and within budget • Assist with development and manufacturing alliance management and product development and manufacturing strategy • Provide technical guidance across CMC elements from banking through drug product, including testing and release • Facilitate communication and alignment between Sabin and external partners • Identify program risks, communicate them, and work with teams on mitigation • Support stakeholder communication and alignment • Author, review, and verify data for Module 3 IND, BLA/MAA, and associated regulatory submissions, including information request responses • Collect information and prepare documentation for future funding efforts • Manage, create, and review CMC and Quality Systems documentation • Support Sabin governance and management systems, including resourcing and financial planning/analysis • Provide written and verbal updates and presentations to internal and external stakeholders • Further development and commercialization activities for Sabin’s cAd3-Marburg and cAd3-Sudan vaccines

🎯 Requirements

• Minimum bachelor’s degree in biochemical engineering, analytical chemistry, pharmaceutical sciences, biochemistry, or a related engineering or pharmaceutical science field • Advanced degree highly desired • Minimum of 10+ years of direct experience with CMC product and process development • Direct experience with CMC biotechnology product and process development • Working knowledge of cell line development and characterization, drug substance, drug product, formulation development, packaging and labeling, analytics, stability programs, and specification setting and justification • Working knowledge of current regulations and industry trends for vaccine/biotechnology product development, manufacture, and testing • Strong project management, problem solving, and interpersonal skills • Strong writing and presentation skills • Direct experience and training in current good manufacturing practices (cGMP) • Working knowledge of ICH guidelines and regional requirements, including FDA, EMEA, and MHRA • Ability to work collaboratively across multiple technical functions and geographical regions and lead in a matrix environment • Ability to work independently with minimal direct oversight • Position may require up to 15% travel in the USA and internationally • Must demonstrate interest in furthering Sabin’s mission • Subject to a criminal background investigation • Request for three professional references • Verification of education/degrees

🏖️ Benefits

• Medical, dental, and vision coverage • Flexible spending accounts • Flexible vacation leave • Sick leave • Short-term disability options • Long-term disability options • 10 federal holidays • End-of-the-year winter break • Employer matching 401(k) plan