Senior Associate Scientist, Injectable Drug Product Development

Alexion Pharma Spain S.L.; New Haven (CT); On-site; USD 110,000 - 165,000; Full time

Job summary

Alexion Pharmaceuticals in New Haven, CT is seeking an Associate Scientist IV to join the Injectable Drug Product Development group. You will develop injectable formulations and support in-use and E&L assessments, analytical method development, and tech transfer of GMP fill-finish processes.

You will work with LC and capillary methods (SEC, IEX, HIC; iCE; LabChip GXII Touch), interpret data, and prepare reports for regulatory submissions (IND, BLA).

Qualifications

• Requires BS/MS in Biochemistry, Chemistry, Chemical Engineering or related field.
• 6+ years with MS or 7+ years with BS preferred.
• Knowledge of cGMP and quality guidelines.

Responsibilities

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

Skills

In-use & E&L assessments

Formulation development & fill-finish

Cross-functional collaboration

Data interpretation & communication

Education

BS/MS in Biochemistry/Chemistry/Chemical Engineering or related

Tools

Empower

JMP

SEC

IEX

HIC

iCE

LabChip GXII Touch

Job description

Alexion Pharmaceuticals in New Haven, CT is seeking an Associate Scientist IV to join the Injectable Drug Product Development group. You will develop injectable formulations and support in-use and E&L assessments, analytical method development, and tech transfer of GMP fill-finish processes.

You will work with LC and capillary methods (SEC, IEX, HIC; iCE; LabChip GXII Touch), interpret data, and prepare reports for regulatory submissions (IND, BLA).