Analytical Development Scientist II - External QC Lead

BioCT Innovation Commons; New Haven, Northern (CT, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

BioCT Innovation Commons seeks a Development Scientist II to join the External Analytical Development and Quality Control group. You will ensure GMP-compliant external QC testing and own laboratory investigations with external labs to enable timely release CoAs.

You will drive end-to-end LIR closures, design testing plans, and collaborate with QA, Analytical Development, and Stability teams to maintain product quality and patient safety.

Qualifications

• Advanced degree (M.S./Ph.D.) in Biochemistry, Chemistry or related field with hands-on analytical development experience.
• 2–5 years (Ph.D.) or 10+ years (M.S.) in biological analytical development in pharma.
• Strong knowledge of cGMP, FDA, ICH and EU regulations.

Responsibilities

• Generate, review, and drive ownership of LIRs to close OOS/OOT/atypical results with root cause analysis and CAPAs.
• Design investigational testing plans ensuring compliant closure of investigations within the quality system.
• Lead cross-functional meetings with QA to align investigations.
• Create plans and track timelines to meet targets and objectives.
• Review analytical data to ensure assay performance meets expectations.
• Identify opportunities to improve quality systems and ensure regulatory compliance.
• Demonstrate strong presentation skills.

Skills

Attention to detail

Analytical problem solving

Root cause analysis

Excellent communication

Documentation proficiency

Education

Advanced degree in Biochemistry or Chemistry

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

JMP

Tableau

SAS

SharePoint

Box

Job description

BioCT Innovation Commons seeks a Development Scientist II to join the External Analytical Development and Quality Control group. You will ensure GMP-compliant external QC testing and own laboratory investigations with external labs to enable timely release CoAs.

You will drive end-to-end LIR closures, design testing plans, and collaborate with QA, Analytical Development, and Stability teams to maintain product quality and patient safety.