Senior Analytical Scientist — Pharma Method Dev & GMP

TPM Labs - A Cormica Lab; New Jersey; On-site; USD 118,000 - 135,000; Full time

Job summary

TPM Laboratories, Inc. is seeking a Principal Scientist to serve as the lab's top technical authority for regulated pharmaceutical analytical programs, setting technical direction and ensuring scientific defensibility.

This role provides expert oversight of complex work and leads critical data deliverables. You will drive method development, validation, transfer, and lifecycle management, oversee complex studies like forced degradation, review data packages for regulatory filings, and represent

Qualifications

• BS in Chemistry or related field (advanced degree strongly preferred).
• 10+ years in pharmaceutical/analytical labs with significant method development/validation leadership.
• Expert knowledge of HPLC/UPLC/GC, dissolution, UV, FTIR; strong cGMP/ALCOA+, FDA/ICH/USP/EP expertise.
• Proven technical writing, client communication, and risk-based decision-making.

Responsibilities

• Lead method development, validation, transfer, and lifecycle management strategy.
• Direct complex studies (including forced degradation) and resolve high-impact OOS/OOT investigations.
• Provide final technical review/approval of critical data packages, protocols, and regulatory-facing documentation.
• Set laboratory-wide technical standards; evaluate and implement new technologies.
• Represent the lab in client audits and regulatory inspections; mentor scientific staff.

Skills

HPLC/UPLC/GC

Dissolution

UV

FTIR

cGMP/ALCOA+

FDA/ICH/USP/EP

Technical writing

Client communication

Risk-based decision-making

Regulatory knowledge

Education

BS in Chemistry

MS or PhD preferred

Tools

HPLC systems

Dissolution equipment

GC instruments

Job description

TPM Laboratories, Inc. is seeking a Principal Scientist to serve as the lab's top technical authority for regulated pharmaceutical analytical programs, setting technical direction and ensuring scientific defensibility.

This role provides expert oversight of complex work and leads critical data deliverables. You will drive method development, validation, transfer, and lifecycle management, oversee complex studies like forced degradation, review data packages for regulatory filings, and represent