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 Manager, Analytical Development is a key leadership role responsible for overseeing both the clinical trial material release and stability program and the analytical validation function. This individual will ensure that all analytical activities are executed in compliance with regulatory requirements, internal quality standards, and project timelines. The role requires a strong scientific foundation, operational excellence, and the ability to lead and develop a high-performing team.
In this position, the Senior Manager will play a pivotal role in supporting the development and lifecycle management of drug products by ensuring the integrity and reliability of analytical data. The ideal candidate will bring a proactive mindset, a passion for continuous improvement, and the ability to collaborate effectively across cross-functional teams including Quality, Regulatory, Manufacturing, and R&D. This is a highly visible role with significant impact on regulatory submissions, product quality, and organizational success.
Essential duties and key job responsibilities and essential functions:
- Oversee the clinical trial material release and stability program, ensuring timely initiation and proactive monitoring of studies.
- Lead the analytical validation program, ensuring methods are validated per ICH and regulatory guidelines.
- Perform data analysis and trending in accordance with industry standards.
- Generate stability and validation reports for regulatory submissions.
- Author and review submission documents, SOPs, protocols, and technical reports.
- Conduct and oversee OOS/OOT investigations and laboratory deviations.
- Assess change controls for impact on stability and validation programs.
- Support regulatory responses, audits, and commercial stability programs.
- Develop and mentor team members through goal setting, development plans, and training ensuring flexibility to accommodate changing timelines and priorities.
- Identify and implement process improvements to enhance efficiency and compliance.
- Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Pharmaceutical Development teams.
- Perform data review, as needed
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- MS or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 10 years of experience in analytical development, stability testing, or validation within the pharmaceutical industry.
- Proven experience managing stability and/or validation programs and leading teams.
- Strong understanding of regulatory requirements (ICH, FDA, EMA) for stability and method validation.
- Proficiency in Empower and data analysis software including JMP and Excel
- Excellent technical writing skills for regulatory and technical documentation.
- Strong project management and organizational skills with the ability to manage multiple priorities in a dynamic environment.
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Mannkind Corporation
May 07, 2025 