- Lead and manage analytical development activities at CROs/CDMOs
- Develop strategies for product and process characterization
- Facilitate tech transfer of methods
- Collaborate with process and quality functions
- Author key regulatory documents
- Track analytical development commitments
- Maintain regulatory compliance standards
- Implement processes for effective collaboration
- Partner with Quality Assurance and Regulatory Affairs
- Provide clear communication on project progress
- Ph.D. or M.S. in relevant field with biopharmaceutical industry experience
- Years of analytical experience
- Experience in CMC analytical development
- Tech transfer and life cycle management experience
- Experience with various biologic modalities
- Hands-on experience in assay development
- Knowledge of therapeutic proteins structure-function relationship
- Project management and team collaboration skills
- Ability to work in a dynamic environment
- Strong leadership and innovation skills
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Vaxess Technologies Cambridge, United StatesLocation: Cambridge, MA · Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary MIMIXTM Microneedle Array Patch technology. MIMIXTM enables self-administration of vaccines and therapeutics to the skin with potential for improved shelf- ...
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Sr. Manager, Large Molecule Analytical Development - Waltham, United States - 1925 GlaxoSmithKline LLC
Description
Senior Manager, Analytical Development, SED
If you're up for the challenge of being a Senior Manager of Analytical Development, then this opportunity is for you! Join our team of scientists at the Strategic External Development (SED) organization, where you'll play a critical role in managing analytical activities for pre-clinical and development-stage biologic candidates. As the project and/or technical lead, you'll work closely with appointed CDMOs to support GSK's biologics pipeline effectively.
Responsibilities of this role include overseeing method development, validation, characterization, comparability studies, and more. You will also be involved in preparing CMC content for regulatory submissions, method transfer, and troubleshooting under minimal guidance. Your contribution will be vital in ensuring the success of large molecule analytical development.
Basic Qualifications:
Preferred Qualifications:
GSK is dedicated to uniting science, technology, and talent to combat disease effectively. Join us in our mission to impact the health of billions of people and deliver sustainable shareholder returns. Our focus on vaccines, specialty, and general medicines, along with cutting-edge technologies, drives our success. At GSK, we value our people and provide a welcoming and inclusive environment where everyone can thrive and grow. Join us on this journey to get Ahead Together!
GSK is an Equal Opportunity Employer committed to diversity and inclusion. We believe in Affirmative Action principles to ensure equal opportunities for all applicants.
