Analytical Development Scientist III – Validation & Methods

MannKind Corporation; Danbury (CT); On-site; USD 120,000 - 170,000; Full time

Job summary

MannKind Corporation, a biopharmaceutical leader focused on cardiometabolic and orphan lung diseases, invites a Scientist III Validation. The role emphasizes hands-on analytical method validation, verification, and lifecycle activities to support clinical programs, with a strong focus on data integrity and regulatory alignment.

You will work under minimal supervision, contribute to cross-functional projects, and support regulatory submissions, ensuring methods are fit-for-purpose and compliant

Qualifications

• Ph.D. in Analytical Chemistry (or MS with significant experience; or BS with substantial relevant work) with 1–3 years (PhD) or 3–5 years (MS) or 4–6 years (BS).
• Hands-on experience with analytical instrumentation and method development.
• Familiarity with ICH guidelines, GMP/GLP, and regulatory expectations.
• Strong organizational, documentation, and communication skills.

Responsibilities

• Develop and optimize analytical methods for drug substances and products using HPLC, LC-MS, GC, UV, and dissolution.
• Execute validation and method transfer activities; generate data and support regulatory documentation.
• Analyze data to support formulation development, stability studies, and clinical release testing.
• Draft protocols, method development reports, and IND-related documentation.
• Collaborate with Formulation, Process Development, and Quality teams to align analytical activities with program needs.
• Maintain GLP/GMP compliance and accurate laboratory records.

Skills

Analytical methods

GMP/GLP knowledge

Regulatory compliance

Data interpretation

Documentation skills

Education

PhD in Analytical Chemistry

MS in related field

BS in Chemistry

Tools

HPLC

LC-MS

GC

UV

Dissolution

Job description

MannKind Corporation, a biopharmaceutical leader focused on cardiometabolic and orphan lung diseases, invites a Scientist III Validation. The role emphasizes hands-on analytical method validation, verification, and lifecycle activities to support clinical programs, with a strong focus on data integrity and regulatory alignment.

You will work under minimal supervision, contribute to cross-functional projects, and support regulatory submissions, ensuring methods are fit-for-purpose and compliant