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Alexion

Global biopharmaceuticals focusing on rare diseases

Associate Scientist 4 - Injectable Drug Product Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeNew Haven, CT, USANo salary listedIn-person

About the Job

Requirements

  • Extensive experience in in-use and extractables and leachables assessment across different phases of development.
  • Extensive experience in developing phase-appropriate formulations and filling finished processes.
  • Working experience with various injectable dosage forms, including vials, prefilled syringes, and cartridges.
  • Comprehensive understanding of chemistry and stability, and degradation mechanisms of proteins and peptides.
  • Hands-on experience with liquid chromatography methods, including size-exclusion chromatography, ion-exchange chromatography, and hydrophobic interaction chromatography, and capillary methods, including imaged capillary isoelectric focusing and LabChip GXII Touch.
  • Strong knowledge of analytical software, including Empower and JMP, and ability to interpret raw data, organize results, and communicate findings to project teams and management.
  • Understanding of the biotechnology product life cycle and factors impacting product stability.
  • Ability to lift or carry 15 or 30 pounds, unassisted or assisted, as applicable; work in a controlled environment around biological, infectious, and hazardous materials; gown and degown personal protective equipment; use a computer; communicate via phone, video, and electronic messaging; engage in problem-solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Responsibilities

  • Execute formulation screening and stability studies for injectable drug products, including proteins, oligonucleotides, and peptides.
  • Build expertise in in-use and extractables and leachables assessments.
  • Support analytical method development and optimization.
  • Support development and technology transfer of good manufacturing practice fill-finish processes to internal and external manufacturing organizations.
  • Write internal technical reports on executed studies.
  • Assist in preparing external regulatory submissions, including investigational new drug applications and biologics license applications, for product candidates.
  • Participate in department meetings and other technical and team-building activities.

Desired Qualifications

  • A Bachelor of Science or Master of Science degree in Biochemistry, Chemistry, Chemical Engineering, or a related discipline from an accredited university, with at least 6 years of experience for candidates with a master's degree or at least 7 years for candidates with a bachelor's degree.
  • Knowledge of current good manufacturing practice and quality guidelines.

About the Company

Alexion

Global biopharmaceuticals focusing on rare diseases

Alexion, now the rare disease group within AstraZeneca, develops and sells therapies for rare and ultra-rare diseases by targeting the complement immune system. Its drugs, such as Soliris and Ultomiris, inhibit the C5 component to slow or stop disease processes, while Strensiq and Kanuma address specific metabolic disorders. It differentiates itself through a deep focus on complement biology, pursuing first- or best-in-class therapies, and using a strategy that blends internal R&D with acquisitions to expand its pipeline. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to a broader international market using AstraZeneca’s scale and capabilities.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1992

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