What are the responsibilities and job description for the Manager, Analytical Development position at MannKind Corporation?
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 Stability Program Manager oversees the clinical trial material release and stability program, ensuring studies are initiated and monitored according to timelines and regulatory commitments. Responsibilities include data analysis, generating stability reports, and authoring submission documents.
Key tasks involve performing OOS/OOT investigations, assessing change controls, and reviewing SOPs and protocols. The role requires flexibility, team development, and continuous improvement initiatives. Additionally, the manager supports regulatory responses, audit requests, and commercial stability.
This position demands strong analytical skills and the ability to manage multiple priorities in a dynamic environment.
Essential duties and key job responsibilities and essential functions:
- Oversees the clinical trial material release / stability program
- Ensures stability studies are initiated within project timelines and proactively monitors studies to ensure compliance with study protocols, quality agreements and regulatory commitments
- Performs data analysis and trending according to industry guidelines
- Ensures team’s flexibility to accommodate changing timelines and priorities
- Generates stability reports for submission to regulatory authorities
- Authors and reviews submission documents, as necessary
- Performs OOS/OOT investigations and laboratory deviation investigations
- Assesses change controls for impacts to the stability program
- Authors and reviews SOPs, protocols, and reports
- Professionally develops team through goal setting, individual development plans, and continuous learning
- Identifies areas for improvement and drives projects to implement solutions
- Interacts and supports regulatory agency responses and audit requests
- Supports commercial release / stability, as needed
- Supports method development / validation, as needed
- Performs 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.
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (Master's or Ph.D. preferred)
- Minimum of 5 years of experience in stability testing, quality control, or a related field within the pharmaceutical or biotechnology industry
- Experience in managing stability programs and leading teams
- Experience in analytical method development and validation, a plus
- Strong understanding of regulatory requirements and guidelines (e.g., ICH, FDA, EMA) related to stability testing
- Proficiency in Empower and data analysis software including JMP and Excel
- Excellent technical writing skills for authoring SOPs, protocols, reports, and regulatory submission documents
- Experience with OOS/OOT investigations and change control assessments
- Strong project management skills with the ability to handle multiple priorities and changing timelines
- This role demands a detail-oriented individual with strong analytical skills and the ability to lead and develop a team in a dynamic environment
Equal Employment Opportunity (EEO)
MannKind values diversity and is firmly committed to providing equal opportunity and a positive working environment in all aspects of employment. It is the policy of MannKind to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Additionally, MannKind prohibits discrimination based on race, color, religion, national origin, sexual orientation, sex, age, disability or any other legally prohibited basis. This applies to all employment practices, including recruiting, hiring, pay, performance reviews, training and development, promotions, and other terms and conditions of employment. MannKind makes hiring decisions based solely on qualifications, merit, and business needs at the time. If you require an accommodation to complete the application or interview process, please contact recruiting@mannkindcorp.com.
