Sr. Scientist, Analytical Development

MannKind

MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.

Job Summary:

The Senior Scientist in Analytical Development is a technical leader responsible for designing and executing analytical strategies to support clinical development programs. This role focuses on method development, validation, and troubleshooting, while also contributing to regulatory documentation and cross-functional collaboration. The Senior Scientist operates with increasing independence and is expected to mentor junior staff and contribute to innovation within the department.

Essential duties and key job responsibilities and essential functions:

• Analytical Method Development: Design and optimize analytical methods for drug substances and products using techniques such as HPLC, LC-MS, GC, and UV.
• Routine Testing: Provide technical oversight and hands-on support for routine analytical testing of drug substances and products, ensuring timely and accurate data generation in alignment with project timelines.
• Validation & Transfer: Lead phase-appropriate method validation and transfer activities to internal and external labs, ensuring compliance with regulatory expectations.
• Regulatory Documentation: Author and review analytical protocols, reports, and sections of regulatory submissions (e.g., IND, IMPD).
• Cross-Functional Collaboration: Serve as the analytical representative on project teams, working closely with Formulation, Process Development, Quality, and Regulatory Affairs.
• Data Integrity & Compliance: Ensure all work adheres to GLP/GMP standards and internal quality systems. Maintain audit readiness and uphold data integrity.
• Problem Solving: Lead investigations into analytical issues such as OOS/OOT results, method variability, and stability excursions.
• Mentorship: Provide technical guidance and mentorship to junior scientists and analysts. Support onboarding and training efforts.
• Innovation & Improvement: Contribute to the evaluation and implementation of new technologies, workflows, and process improvements.
• Scientific Communication: Present data and recommendations to internal stakeholders and contribute to technical reports and publications.
• Other Duties: Perform additional tasks as assigned to support the Analytical Development function.

Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 3-5 years of experience, or M.S. with 5-7 years of relevant experience.
• Strong background in analytical method development and validation.
• Experience supporting clinical-stage pharmaceutical development.
• Familiarity with ICH guidelines, GMP/GLP, and regulatory documentation.
• Excellent problem-solving, communication, and organizational skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Proficient knowledge of Empower software for chromatographic data acquisition, processing, and reporting.
• Familiarity with inhalation drug delivery systems and aerosol testing is a plus.