Sr. Scientist, Analytical Development (Contract to Hire 6-9 Months)

MannKind Corporation; Danbury (CT); On-site; USD 140,000 - 190,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical problem-solving

Communication skills

Organizational skills

Mentorship abilities

Education

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

M.S. in a relevant field

B.S. in a related field

Tools

HPLC

LC-MS

GC

UV

Dissolution

Job description

MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension.

MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.

At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.

Summary

The Senior Scientist – Validation is a technical leader responsible for establishing, executing, and maintaining robust analytical method validation strategies across the product lifecycle, with primary focus on validation, verification, and lifecycle management of analytical procedures in alignment with global regulatory expectations (ICH Q2(R2), ICH Q14, USP <1220>, FDA/EMA guidance).

This role ensures that analytical methods are fit-for-purpose, stability-indicating, and compliant with phase-appropriate validation requirements, while supporting clinical and commercial programs. The Senior Scientist operates with a high degree of independence, contributes to regulatory submissions, and provides mentorship and cross-functional leadership.

Key Responsibilities

• Analytical Method Development: 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. Make technical decisions on method approach, prioritization, and phase-appropriateness.
• Validation & Transfer: 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.
• Regulatory Documentation: Author and review analytical protocols, reports, and sections of regulatory submissions (e.g., IND, IMPD).
• Cross-Functional Collaboration: 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 in partnership with Formulation, Process Development, Quality, and Regulatory Affairs.
• External Vendor Oversight: Manage analytical work at CROs and CDMOs, including method transfers, troubleshooting, and data review.
• 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 complex analytical issues such as OOS/OOT results, method variability, and stability excursions. Drive root cause analysis, define corrective actions, and partner with Quality on resolution.
• 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.

Required Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 2–5 years of experience, M.S. with 4–6 years or B.S. with 6-8 years.
• Strong background in analytical method validation.
• Experience supporting clinical-stage pharmaceutical development.
• Familiarity with ICH guidelines, GMP/GLP, and regulatory documentation.
• Excellent problem-solving, communication, and organizational skills.

Preferred Qualifications

• Experience with complex dosage forms or delivery systems (e.g., inhalation, liposomal, peptides).
• Prior experience managing CRO/CDMO relationships.
• Exposure to regulatory submissions and health authority interactions.
• Experience mentoring or supervising junior staff.