Lead Scientist, Analytical Method Validation

MannKind Corporation; Danbury (CT); In loco; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

MannKind Corporation seeks a Senior Scientist – Validation to lead analytical method validation across the product lifecycle, focusing on ICH Q2(R2), Q14, USP <1220>, and FDA/EMA guidance.

You will oversee method development, transfer, ATP setup, and data integrity, while mentoring junior staff and coordinating with Regulatory, Quality, Formulation, and Process Development. This role supports clinical and commercial programs.

Competenze

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Experience validating analytical methods and supporting clinical-stage programs.
• Familiarity with ICH guidelines, GMP/GLP, and regulatory documentation.

Mansioni

• Define the analytical method strategy for assigned programs. Design and optimize methods for drug substances and products using techniques such as HPLC, LC-MS, GC, UV, and dissolution.
• Define and lead phase-appropriate method validation and transfer strategies for assigned programs. Oversee execution by internal and external labs, ensure compliance with regulatory expectations, and resolve validation issues that arise.
• Set up and oversee Analytical Target Profiles (ATP), ensuring methods meet required performance standards through well justified validation approaches.
• Manage the analytical procedure lifecycle, including ongoing performance checks, trend analysis, and regular reviews to maintain method reliability.
• Author and review analytical protocols, reports, and sections of regulatory submissions (e.g., IND, IMPD).
• Serve as the analytical lead on assigned project teams. Drive analytical decisions, communicate technical risks and priorities, and align analytical activities with broader program objectives.
• Manage analytical work at CROs and CDMOs, including method transfers, troubleshooting, and data review.
• Ensure all work adheres to GLP/GMP standards and internal quality systems. Maintain audit readiness and uphold data integrity.
• Lead investigations into complex analytical issues such as OOS/OOT results, method variability, and stability excursions.

Conoscenze

Analytical problem-solving

Communication skills

Organizational skills

Mentorship abilities

Formazione

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

M.S. in a relevant field

B.S. in a related field

Strumenti

HPLC

LC-MS

GC

UV

Dissolution

Descrizione del lavoro

MannKind Corporation seeks a Senior Scientist – Validation to lead analytical method validation across the product lifecycle, focusing on ICH Q2(R2), Q14, USP <1220>, and FDA/EMA guidance.

You will oversee method development, transfer, ATP setup, and data integrity, while mentoring junior staff and coordinating with Regulatory, Quality, Formulation, and Process Development. This role supports clinical and commercial programs.