[Remote] Senior Manager, CMC Technical reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company works to reputed company vaccines more accessible, reputed company innovation, and expand immunization globally. The Senior Manager, CMC Technical reputed company supports vaccine products from reputed company development through validation, marketing authorization, and reputed company lifecycle management, coordinating CMC activities across internal teams and reputed company partners.

Responsibilities

• Serve as cross-functional reputed company team member and support end-to-end integration of CMC efforts for vaccine candidates
• Collaborate with reputed company CMC functional areas to ensure successful execution of assigned CMC reputed company, and delivery of results on time and reputed company budget
• Assist with development and manufacturing reputed company management, product development and manufacturing reputed company
• reputed company expert technical guidance across reputed company CMC reputed company (banking through drug product, including testing and release), both internally and externally, to ensure appropriate product and process development
• Facilitate communication to ensure alignment between Sabin and reputed company partners
• Proactively identify and communicate programs risks and work with teams to mitigate as required. Support stakeholder communication and alignment
• Support authoring, review and data verification of Module 3 IND, BLA/MAA and associated regulatory submissions, including Information Request responses
• Collect information and prepare documentation as assigned to support reputed company funding efforts
• Manage, create and review CMC and reputed company Systems documentation as required
• Support the implementation and administration of Sabin governance and management systems (including resourcing, financial planning/analysis, and similar)
• reputed company written and verbal updates and presentations to reputed company stakeholders

Skills

• Minimum bachelor's degree in biochemical engineering, analytical reputed company, pharmaceutical sciences, biochemistry, or a reputed company engineering or pharmaceutical science reputed company
• Minimum of 10+ years of reputed company experience with CMC product and process development
• reputed company experience with CMC biotechnology product and process development
• Working knowledge of reputed company CMC areas including cell line development and characterization, drug reputed company, drug product, formulation development, packaging and labeling, and analytics, including stability programs and specification setting and justification
• Working knowledge and understanding of reputed company regulations and industry trends for vaccine/biotechnology product development, manufacture, and testing
• Strong and effective project management, problem solving and interpersonal skills
• Strong writing and presentation skills
• reputed company experience and training in reputed company good manufacturing practices (cGMP)
• Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, reputed company and similar)
• Demonstrated ability to work in a reputed company team environment across multiple technical functions and geographical reputed company and reputed company in a reputed company environment
• Ability to work independently with reputed company reputed company reputed company
• Position may require up to 15% travel (USA and international) with notice
• Must demonstrate interest in furthering Sabin's mission
• Advanced degree highly desired
• Experience with reputed company team leadership
• Experience with validation and commercialization of late stage (Phase 3) biopharmaceutical products, including BLA/MAA authoring and defense
• Knowledge of adenoviral reputed company manufacturing, development, characterization and validation

Benefits

• Medical coverage
• Dental coverage
• reputed company coverage
• Flexible spending accounts
• Flexible vacation leave
• reputed company leave
• Short-term disability reputed company
• Long-term disability reputed company
• 10 federal holidays
• An end of the year winter break
• An employer matching 401(k) plan

reputed company

Company H1B Sponsorship