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

MannKind Corporation; Danbury (CT); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical methods

GMP/GLP knowledge

Regulatory compliance

Data interpretation

Documentation skills

Formazione

PhD in Analytical Chemistry

MS in related field

BS in Chemistry

Strumenti

HPLC

LC-MS

GC

UV

Dissolution

Descrizione del lavoro

MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

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 Scientist III Validation is responsible for execution of analytical method validation, verification, and lifecycle activities to support clinical and early commercial programs. This role focuses on hands‑on validation work, protocol execution, data analysis, and documentation, ensuring methods are fit‑for‑purpose and compliant with global regulatory expectations (ICH Q2(R2), ICH Q14, USP <1220>, FDA/EMA guidance).

Scientist III works under minimum supervision, contributes to cross‑functional projects, and supports regulatory submissions.

Key Responsibilities

• Analytical Method Development: Independently develop and optimize analytical methods for assigned drug substances and products using techniques such as HPLC, LC‑MS, GC, UV, and dissolution. Make sound technical decisions on method design and execution within the scope of the assigned work.
• Method Validation & Transfer: Execute phase‑appropriate validation and method transfer activities, including protocol execution, data generation, and report contribution, under the guidance of senior staff who define the overall validation strategy.
• Data Generation & Interpretation: Execute experiments, analyze data, and draw conclusions to support formulation development, stability studies, and clinical release testing.
• Documentation: Draft analytical protocols, method development reports, and contribute to regulatory documentation (e.g., IND sections).
• Cross‑Functional Support: Collaborate with Formulation, Process Development, and Quality teams to ensure alignment of analytical activities with program needs.
• Compliance & Data Integrity: Ensure all work is conducted in accordance with GLP/GMP standards and internal quality systems. Maintain accurate and complete laboratory records.
• Problem Solving: Troubleshoot analytical methods and instrumentation issues with increasing independence.
• Mentorship & Training: Provide informal mentorship to junior scientists and analysts. Assist in onboarding and training activities.
• Continuous Improvement: Identify opportunities to improve workflows, documentation practices, or analytical robustness. Drive implementation of improvements within the scope of assigned work, with senior support on broader changes.
• Scientific Communication: Present experimental results and recommendations in team meetings and contribute to technical discussions.

Required Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1–3 years of experience, or M.S. with 3–5 years, or B.S. with 4–6 years of relevant experience.
• Hands‑on experience with analytical instrumentation and method development.
• Familiarity with ICH guidelines, GMP/GLP, and regulatory expectations.
• Strong organizational, documentation, and communication skills.

Preferred Qualifications

• Experience supporting clinical‑stage pharmaceutical development.
• Exposure to regulatory submissions and method validation.
• Experience working with CROs or CDMOs.
• Familiarity with LIMS or electronic lab notebooks.

Core Competencies (Aligned to Company Values)

• Do Right: Follows SOPs and quality standards; ensures data integrity and compliance.
• Win Together: Collaborates effectively with team members and cross‑functional partners.
• Own It: Takes ownership of assigned analytical work end to end, including planning, execution, documentation, and follow‑through.
• Be Tenacious: Independently resolves routine technical challenges and pursues continuous improvement in assigned areas.
• Push Boundaries: Suggests improvements to methods, workflows, or technologies.