Lead QC Analytical Specialist (Biologics)

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Syngene seeks a Principal Specialist – Quality Control Analytical Lead in Baltimore to direct the QC Analytical team and ensure GLP compliance across large‑molecule manufacturing. The role combines hands‑on testing with leadership of analysts, coordinating with QA, Regulatory, and Manufacturing to meet timelines and audit readiness.

The ideal candidate will have 8–12 years in QC within biologics or pharma, strong analytical method expertise, and a track record of continuous improvement and

Qualifications

• 8–12 years Quality Control experience in biologics/pharma manufacturing.
• Experience supporting regulatory inspections and third‑party audits.
• Strong knowledge of biologic analytical techniques and method validation.
• Leadership of cross‑functional teams and continuous improvement.
• Good understanding of GLP and pharmacopeial standards.

Responsibilities

• Lead QC Analytical operations for large molecule products.
• Oversee sampling, testing, and method qualification/transfer.
• Coordinate with QA, Regulatory Affairs, Manufacturing, and Supply Chain.
• Ensure documentation, SOPs, IOPs, EOPs are updated and compliant.
• Investigate OOS/OOT, CAPA, and audit observations.
• Support regulatory filings and client communications.

Skills

Leadership

Cross-functional collaboration

Regulatory understanding

Audit readiness

Data integrity (ALCOA)

Education

Bachelor’s in Chemistry/Biochemistry/ Chemical Eng

Master’s in related field (desired)

Job description

Syngene seeks a Principal Specialist – Quality Control Analytical Lead in Baltimore to direct the QC Analytical team and ensure GLP compliance across large‑molecule manufacturing. The role combines hands‑on testing with leadership of analysts, coordinating with QA, Regulatory, and Manufacturing to meet timelines and audit readiness.

The ideal candidate will have 8–12 years in QC within biologics or pharma, strong analytical method expertise, and a track record of continuous improvement and