Senior Associate Scientist – Injectable Drug Product Development

BioCT Innovation Commons; New Haven (CT); Hybride; USD 90 000 - 130 000; Plein temps

Résumé du poste

BioCT Innovation Commons is seeking an Associate Scientist IV to join the Injectable Drug Product Development group. You will develop injectable formulations and fit-for-purpose analytical methods, perform analytical testing, and draft study reports.

The role requires independent work within a dynamic team and collaboration across Product Development and Clinical Supply. You will execute formulation screening, contribute to in-use and E&L assessments, and support GMP fill-finish tech transfer.

Qualifications

• BS or MS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline with 6+ years (MS) or 7+ years (BS) of experience.
• Extensive experience in in-use and E&L assessment across development phases.
• Experience developing phase-appropriate formulations and filling finished processes.
• Working experience with various injectable dosage forms in vials, prefilled syringes/cartridges.

Responsabilités

• 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 to internal and external manufacturing.
• Write internal technical reports on executed studies.
• Assist in preparation of external regulatory submissions (IND, BLA) for Alexion product candidates.
• Participate in department meetings and other technical activities.

Connaissances

Formulation development

Analytical method development

In-use and E&L assessment

Cross-functional collaboration

Formation

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

Outils

Empower

JMP

iCE

LabChip GXII Touch

SEC

IEX

HIC

Description du poste

BioCT Innovation Commons is seeking an Associate Scientist IV to join the Injectable Drug Product Development group. You will develop injectable formulations and fit-for-purpose analytical methods, perform analytical testing, and draft study reports.

The role requires independent work within a dynamic team and collaboration across Product Development and Clinical Supply. You will execute formulation screening, contribute to in-use and E&L assessments, and support GMP fill-finish tech transfer.