Alexion’s Global Product Development organization is seeking an experienced synthetic organic chemist to expand our process development capabilities in support of an emerging portfolio of small molecules, synthetic peptides, and oligonucleotides. The Scientist III, Synthetic Chemical Development will leverage deep expertise in synthetic organic chemistry to design safe, scalable, and robust synthetic routes. Responsibilities include delivering a comprehensive strategy for the design and development of drug substance processes, articulating timeline and resource requirements to Alexion management, providing technical oversight for development and manufacturing activities at third parties, and communicating technical findings to a broad cross-functional team of stakeholders.
Job Duties & Responsibilities
- Articulate a comprehensive strategy for drug substance process development. Ensure that a stage-appropriate level of process knowledge is maintained throughout development, such that a robust supply of drug substance is ensured from pre-clinical studies through regulatory submission, marketing approval, and commercial launch.
- Provide expert evaluation of the technical capabilities and quality systems of prospective CRO and CMO partners. Establish strong working relationships with third parties that meet Alexion’s exacting standards for technical excellence and quality compliance.
- Ensure technical readiness of CMOs for process validation, pre-approval inspection, and commercial launch. Provide on-site technical support during process validation and on-site inspection, and as needed at earlier stages of development.
- Partner with drug product and analytical development colleagues in developing an integrated and holistic CMC control strategy, consistent with Quality by Design (QbD) expectations.
- Provide technical expertise to enable authoring of drug substance modules for regulatory documents that convey phase-appropriate scientific understanding of process and product, spanning IND and IMPD submissions through NDA and MAA marketing applications. Represent Alexion in interactions with global regulatory agencies.
- Ph.D. in organic chemistry with minimum 10 years post-doctoral experience and minimum 5 years experience in the biopharma industry (job level commensurate with experience). Deep understanding of the design, development, optimization, and tech transfer of drug substance manufacturing processes.
- Ability to manage process design and development activities at third party service providers.
- Up to 15% travel, with ability to work independently from remote locations.
- Strong understanding of cGMPs and regulatory guidances.
- Technical expert who will remain abreast of the latest scientific and regulatory trends pertaining to synthesis of small molecules, synthetic peptides, and oligonuclotides. Evaluate new and emerging chemistry and process technologies. Cultivate relationships with third parties willing to deploy innovative technologies that will improve cycle time, supply chain robustness, process greenness, and/or product quality.
- Expertise with impurity structural elucidation, reaction mechanism elucidation, and design and execution of fate and purge studies. Expertise in genotoxicity risk assessment per ICH M7.
- Expertise with early-phase small molecule process development, particularly route scouting and route selection.
- Expertise in development of continuous drug substance manufacturing processes.
- Expertise in chemometrics, including use of multivariate data analysis, in situ reaction monitoring, reaction profiling, and development of first-principles (mechanistic) process chemistry models.
- Expertise with automated synthesis, high throughput automation, and/or automated lab reactors.
- Experience (academic or industrial) with solid phase peptide synthesis or solid phase oligonucleotide synthesis.
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