*This position will be remote based in New Haven, CT with the expectation of being onsite 1-2 days per quarter*
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 Associate IV, Small Molecule Process Chemistry will couple strong laboratory skills with experience in synthetic route design and process scale-up. Laboratory responsibilities will include route scouting, impurity synthesis, quantitative fate and purge studies, as well as experiments designed to elucidate reaction mechanisms and allow for regression of kinetic parameters. Process scale-up responsibilities will include the design of safe, scaleable, and cost efficient synthetic routes, and technical oversight for process development and cGMP manufacturing activities at third parties.
Job Duties & Responsibilities
- Devise and execute route scouting studies to enable selection of safe, scaleable, and cost efficient synthetic routes to drug substance and regulatory starting materials.
- Provide technical stewardship for process development activities at third parties spanning preclinical through commercial launch. Ensure that a phase-appropriate level of process and product knowledge is maintained throughout the development lifecycle.
- Provide technical stewardship for external cGMP drug substance manufacture on multi-kilogram scale. Ensure that third parties meet Alexion’s exacting standards for technical excellence and quality compliance. Ensure that a robust basis of safety is documented prior to process scale-up.
- Serve as Alexion’s technical lead for batch record review, deviation management, and root cause analysis arisng from manufacturing activities at third parties.
- Ensure CMO readiness for process validation, pre-approval inspection, and commercial launch. Provide on-site technical support during process validation, and as needed at earlier stages of development.
- Provide technical insights supporting preparation of regulatory submission documents and responses to health authority queries.
- B.S. organic chemistry with minimum 12 years experience in the biopharma industry (or M.S. with minimum 8 years industrial experience).
- Deep understanding of the design, development, and scale-up of small molecule drug substance manufacturing processes.
- Ability to remotely manage process design, development, and scale-up activities at third parties.
- Up to 10% travel, with ability to work independently from remote locations.
- Strong understanding of cGMPs and regulatory guidances.
- Strong understanding of Quality by Design (QbD) principles of process design.
- Technical expert who will remain abreast of the latest scientific and regulatory trends pertaining to synthesis of small molecules. Evaluate emerging chemistry technologies with potential to improve cycle time, supply chain robustness, process greenness, and/or product quality.
- Experience in late-phase process development, including process risk assessments, univariate PAR studies, multivariate DOE studies, and assessment of parameter criticality.
- Expertise with impurity structural elucidation, reaction mechanism elucidation, and design and execution of fate and purge studies.
- 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.
New Haven, CT, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.