Senior Formulation Scientist, Injectable Drug Products

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 120,000 - 160,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking an Associate Scientist IV to join the Injectable Drug Product Development group in New Haven, CT. You will develop injectable formulations, perform analytical testing, and draft reports for executed studies, working independently within a dynamic, collaborative team.

You will support GMP fill-finish tech transfer, participate in regulatory submission prep, and communicate results across cross-functional teams to ensure timely project progression.

Qualifications

• Extensive experience in in-use and E&L assessment across development phases.
• Experience in developing phase-appropriate formulations and filling finished processes.
• Working experience with injectable dosage forms in vials, prefilled syringes/cartridges.

Responsibilities

• Execute formulation screening and stability studies for injectable drug products (proteins, oligonucleotides, peptides).
• Build expertise in in-use and extractables/leachables assessments.
• Support analytical method development and optimization.
• Support development and tech transfer of GMP fill-finish processes to internal/external manufacturers.
• Write internal technical reports on executed studies.
• Assist in preparing external regulatory submissions (IND, BLA) for Alexion candidates.
• Participate in department and team-building activities.

Skills

In-use & E&L assessment

Formulation development

Analytical method development

LC methods (SEC, IEX, HIC)

Capillary methods (iCE, LabChip GXII)

Analytical software (Empower, JMP)

Cross-functional collaboration

Education

BS in Biochemistry/Chemistry/Chemical Engineering

MS in Biochemistry/Chemistry (preferred)

Tools

GMP fill finish processes

Regulatory submissions support (IND, BLA)

Job description

Alexion Pharmaceuticals, Inc. is seeking an Associate Scientist IV to join the Injectable Drug Product Development group in New Haven, CT. You will develop injectable formulations, perform analytical testing, and draft reports for executed studies, working independently within a dynamic, collaborative team.

You will support GMP fill-finish tech transfer, participate in regulatory submission prep, and communicate results across cross-functional teams to ensure timely project progression.