Senior Manager, Chemical Development
5 hours ago
GSK is seeking a highly skilled Senior Manager, Chemical Development to join our team. As a key member of our Chemical Development department, you will be responsible for the development, optimization, and implementation of robust, cost-effective, and safe processes for the manufacture of small molecules, including oligonucleotide active pharmaceutical ingredients (APIs) and antibody drug conjugates (ADCs).
Key Responsibilities:- Develop and implement process development strategies to support the manufacture of small molecules.
- Collaborate with cross-functional teams to ensure timely delivery of drug substance to support IND/IMPD enabling toxicology studies and phase-appropriate cGMP drug substance.
- Work closely with external partners to evaluate, technology transfer, scale-up, and implement new processes for drug substance manufacture, including support of validation activities.
- Recommend the development of economical, state-of-the-art techniques to synthesize, purify, isolate, and characterize drug substance.
- Troubleshoot new and existing product or process issues related to yield, quality, and throughput.
- PhD in synthetic organic chemistry with 5+ years of experience in pharmaceutical research and development in the biotechnology or pharmaceutical industry OR a BS/MS and 8+ years of industry experience.
- Experience in process development, process characterization, process validation, and product life cycle management.
- Experience working in a virtual CMC development/commercialization environment and collaborating with external partners (CDMOs/CROs).
- Extensive knowledge of oligonucleotide chemistry, including potential routes of impurity formation and the ability to develop processes to oligonucleotide drug targets.
- Practical experience of laboratory and/or plant scale oligonucleotide synthesis, purification, and isolation.
- Fundamental understanding of the role of ADCs in the biopharmaceutical industry, with knowledge of the technical challenges of development and manufacture.
GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles. We are committed to diversity and inclusion in the workplace and welcome applications from qualified candidates from diverse backgrounds.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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