*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 establish our process development capability in solid phase peptide synthesis (SPPS). The Associate IV, Solid Phase Peptide Synthesis will serve as the subject matter expert for SPPS within Alexion. Responsibilities include delivering a comprehensive strategy for the development, scale-up, and optimization of drug substance SPPS processes, articulating timeline and resource requirements to Alexion management, providing technical oversight of development and manufacturing activities at third parties, and communicating key technical findings to a cross-functional team of stakeholders.
Job Duties & Responsibilities
- Oversee the implementation of a comprehensive drug substance process development program spanning preclinical through commercial launch, leveraging external development organizations. Ensure that a stage-appropriate level of process and product knowledge is maintained throughout the development lifecycle.
- Build Alexion’s external network for SPPS. Identify and evaluate technical and quality capabilities of prospective CROs and CMOs. Establish and maintain strong working relationships with third parties that meet Alexion’s exacting standards for technical excellence and quality compliance.
- Lead tech transfer to cGMP facilities. Partner with CMOs to diagnose and remediate process upsets. Partner with QA groups to support product impact assessments and establish CAPAs.
- Communicate key technical findings and challenges to a cross-functional team of stakeholders, including assessment of impacts to budget, timeline, quality, regulatory, and clinical supply.
- Ensure CMO readiness for process validation, pre-approval inspection, and commercial launch of cGMP SPPS manufacturing processes. Provide on-site technical support for process validation and pre-approval inspection, and as needed at earlier stages of development.
- Provide expert 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).
- First-hand industrial experience in process design, development, and scale-up of SPPS to enable cGMP manufacture at third parties.
- Ability to remotely manage the design, development, and scale-up of SPPS at third parties.
- Up to 15% travel, with ability to work independently from remote locations.
- Strong understanding of cGMPs and regulatory guidances pertaining to synthetic peptides.
- 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 synthetic peptides. Evaluate emerging chemistry and process technologies with potential to improve cycle time, supply chain robustness, process greenness, and/or product quality.
- Experience (academic or industrial) with solid phase oligonucleotide synthesis.
- Experience in late-phase process development for SPPS, including process risk assessments, univariate PAR studies, multivariate DOE studies, and assessment of parameter criticality.
- Experience in development of continuous drug substance manufacturing processes.
- 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.