Analytical Development Scientist — External QC & Investigations

BioCT; New Haven (CT); Presencial; USD 112.000 - 168.000; Jornada completa

Descripción de la vacante

BioCT is seeking a Development Scientist II to provide scientific and operational oversight of external analytical laboratories supporting biologic drug substances and products. You will lead investigations, review data and documentation, and collaborate across QA, stability, manufacturing, and regulatory teams to ensure timely, compliant outcomes.

You will drive continuous improvement of external laboratory oversight, contribute to regulatory submissions, and support audits with scientifically

Formación

• Ph.D. in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands-on biological analytical development experience.
• Experience supporting GMP analytical testing for biologic products.
• Experience leading or supporting lab investigations (OOS, OOT, atypical) with root-cause analysis.
• Strong data evaluation, report writing, and technical documentation skills.
• Knowledge of GMP, FDA, ICH, USP, and EP expectations.

Responsabilidades

• Provide scientific and operational oversight of external analytical labs.
• Lead investigations from initiation to closure, including OOS/OOT, with justified strategies.
• Coordinate testing activities and timelines with contract laboratories and internal partners.
• Review protocols, raw data, COAs, and stability data for disposition and regulatory commitments.
• Drive continuous improvement in external lab oversight and documentation processes.
• Support audit, inspection, and regulatory readiness with complete and traceable records.

Conocimientos

Analytical oversight

Lab investigations

Scientific writing

Cross-functional collaboration

Quality control

Educación

Ph.D. in Biochemistry/Chemistry or related

M.S. with 10+ years hands-on experience

Herramientas

Veeva Vault Quality

LIMS systems

ValGenesis

Kneat

Descripción del empleo

BioCT is seeking a Development Scientist II to provide scientific and operational oversight of external analytical laboratories supporting biologic drug substances and products. You will lead investigations, review data and documentation, and collaborate across QA, stability, manufacturing, and regulatory teams to ensure timely, compliant outcomes.

You will drive continuous improvement of external laboratory oversight, contribute to regulatory submissions, and support audits with scientifically