Development Scientist II, External QC & Analytics

Alexion Pharma Spain S.L.; New Haven (CT); Presencial; USD 112.000 - 168.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Short-term incentive bonuses

Equity-based awards

Commissions for sales roles

Retirement programs

Paid time off

Health, dental, and vision coverage

Descripción de la vacante

Development Scientist II at Alexion Pharma Spain S.L. in New Haven, CT focuses on providing scientific and operational oversight of external analytical laboratories for biologic drug substance and drug product programs.

You will lead investigations, translate program requirements into testing requests, and ensure timely, compliant data delivery to support batch release, stability, and regulatory submissions.

Formación

• Advanced degree in Biochemistry, Chemistry or related with relevant analytical development experience.
• Experience supporting GMP analytical testing for biologic substances/products.
• Strong ability to lead investigations and communicate conclusions clearly.

Responsabilidades

• Provide scientific/operational oversight of external analytical labs performing release, stability, and verification testing.
• Lead investigations from initiation to closure including OOS/OOT and atypical results.
• Serve as primary technical liaison with contract laboratories and internal partners.
• Review protocols, raw data, COAs, and analytical reports supporting regulatory commitments.
• Coordinate external testing activities across programs and track deliverables.

Conocimientos

GMP analytical testing

Laboratory investigations

Data analysis

Scientific writing

Educación

Ph.D. in Biochemistry/Chemistry or related

M.S. in Biochemistry/Chemistry or related

Herramientas

Veeva Vault QMS

LIMS

JMP/Tableau

Descripción del empleo

Development Scientist II at Alexion Pharma Spain S.L. in New Haven, CT focuses on providing scientific and operational oversight of external analytical laboratories for biologic drug substance and drug product programs.

You will lead investigations, translate program requirements into testing requests, and ensure timely, compliant data delivery to support batch release, stability, and regulatory submissions.