Scientist II, Analytical Development MannKind Corporation - 3.7 Bedford, MA Job Details $73,006 - $110,400 a year 1 day ago Qualifications Regulatory compliance Good documentation practices (GDP) ICH guidelines GMP for research safety and compliance Full Job Description MannKind 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 Scientist II in Analytical Development is an early-career scientific contributor who supports method development, validation, and routine testing activities for clinical programs. This role is designed for scientists with foundational experience who are ready to operate with moderate independence, contribute to technical problem-solving, and grow into more complex responsibilities. The Scientist II works closely with senior team members and cross-functional partners to ensure high-quality data generation and compliance with regulatory standards.

Key Responsibilities Analytical Method Development:

Contribute to method development and optimization activities by designing and executing defined experiments under the guidance of senior scientists. Apply standard analytical techniques such as HPLC, UV, GC, cascade impaction, and dissolution.

Method Execution and Data Analysis:

Perform routine and non-routine testing to support formulation development, stability studies, and clinical material release. Analyze and interpret results, identify trends, and present findings to the team.

Documentation:

Draft and maintain laboratory notebooks, technical reports, and method development summaries in compliance with internal SOPs and regulatory expectations.

Compliance & Quality:

Ensure all work is conducted in accordance with GLP/GMP standards. Maintain accurate records and support audit readiness.

Troubleshooting:

Participate actively in troubleshooting analytical methods and instrumentation issues, with support from senior staff as needed.

Cross-Functional Collaboration:

Participate in cross-functional discussions with Formulation, Process Development, and Quality teams. Contribute analytical perspectives to support program needs and timelines.

Continuous Learning:

Stay current with analytical techniques and regulatory expectations. Participate in training and development opportunities.

Process Improvement:

Identify opportunities to improve laboratory workflows, documentation practices, or analytical robustness based on direct experience, and propose practical solutions to senior staff.

Team Contribution:

Support team goals by contributing to shared lab responsibilities and participating in group meetings and discussions. Required Qualifications M.S. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1-3 years of experience, or B.S. with 2-4 years of relevant experience. Hands-on experience with analytical instrumentation and data analysis. Familiarity with ICH guidelines, GMP/GLP, and laboratory documentation practices. Strong attention to detail, organizational skills, and a demonstrated ability to apply learning to new technical challenges. Preferred Qualifications Experience supporting clinical-stage pharmaceutical development. Exposure to method validation and regulatory documentation. Familiarity with electronic lab notebooks or LIMS systems. Experience working in a regulated environment or with CROs/CDMOs. Experience working with small molecules. 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 supports shared goals.

Own It:

Takes responsibility for assigned tasks and delivers high-quality results.

Be Tenacious:

Demonstrates persistence in resolving technical challenges and refines approaches based on results.

Push Boundaries:

Proposes practical improvements and explores new technical approaches with appropriate support.