Senior Formulation Scientist, Injectable Drug Product Development

AstraZeneca plc; New Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

AstraZeneca plc is seeking an Associate Scientist IV to join the Injectable Drug Product Development group to support formulation and drug product process development for Alexion's biotherapeutic candidates.

The role involves developing injectable formulations, performing analytical testing, drafting study reports, and collaborating across functions. Strong LC/Capillary methods and analytical software skills are essential, with a focus on timely, compliant deliverables.

Qualifications

• Extensive experience in in-use and E&L assessment across development phases.
• Experience developing phase-appropriate formulations and filling finished processes.
• Experience with various injectable dosage forms (vials, prefilled syringes).
• Strong understanding of chemistry, stability, and degradation of proteins/peptides.
• Excellent interpersonal and communication skills; able to work in cross-functional settings.

Responsibilities

• Execute formulation screening and stability studies for injectable products including proteins, oligos, and peptides.
• Develop expertise in in-use and extractables & leachables assessments.
• Support analytical method development and optimization.
• Support GMP fill-finish tech transfer to manufacturing organizations.
• Write internal technical reports on studies.
• Assist in preparation of regulatory submissions (IND, BLA).
• Participate in department meetings and team activities.

Skills

LC methods

Capillary methods

Analytical software

Cross-functional

Biochemistry knowledge

Communication skills

Education

BS in Biochemistry/Chemistry

MS preferred

Tools

SEC

IEX

HIC

LabChip GXII Touch

iCE

Empower

JMP

Job description

AstraZeneca plc is seeking an Associate Scientist IV to join the Injectable Drug Product Development group to support formulation and drug product process development for Alexion's biotherapeutic candidates.

The role involves developing injectable formulations, performing analytical testing, drafting study reports, and collaborating across functions. Strong LC/Capillary methods and analytical software skills are essential, with a focus on timely, compliant deliverables.