Sr. Scientist, Analytical Development/Data Reviewer
Sr. Scientist, Analytical Development/Data Reviewer
Posted on :
01-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
01-08-2025
Job Description
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 Data Reviewer within the Analytical Development team at MannKind plays a critical role in ensuring the accuracy completeness and integrity of analytical data generated to support clinical programs. This position is responsible for the independent review of raw data chromatographic results and analytical documentation to ensure compliance with internal procedures industry best practices and regulatory expectations.
At MannKind data integrity is a core value and this role is essential in upholding that standard. The Data Reviewer works closely with laboratory scientists quality assurance and management to ensure that all data meets the requirements outlined in FDA EMA and ICH guidance including ALCOA principles (Attributable Legible Contemporaneous Original Accurate Complete Consistent Enduring and Available).
Essential duties and key job responsibilities and essential functions:
- Data Review: Perform detailed review of analytical data packages chromatographic data (e.g. Empower) calculations laboratory notebooks and final reports.
- Compliance Assurance: Ensure data is recorded and reported in compliance with internal SOPs cGMP ICH and FDA 21 CFR Part 11 requirements.
- Issue Identification: Identify and escalate discrepancies inconsistencies or deviations in data or documentation.
- Collaboration: Work closely with analysts and management to resolve data issues and ensure timely completion of reviews.
- Instrument Support: Support instrument calibration maintenance and troubleshooting in collaboration with lab staff.
- Lab Operations Assistance: Assist with lab operations including reagent preparation equipment verification and documentation updates.
- Audit Readiness: Ensure data packages are complete well-organized and inspection-ready to support internal and external audits.
- Process Improvement: Contribute to continuous improvement initiatives related to data review processes and documentation practices.
- Training Support: Assist in training team members on data integrity principles and review expectations.
- Other Duties: Perform additional tasks as assigned to support the Analytical Development function.
Minimum qualifications to perform the job; specific skills education knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- Bachelors degree in Chemistry Biochemistry Pharmaceutical Sciences or a related field.
- Minimum of 5 years of experience in a GMP-regulated analytical laboratory or quality environment.
- Strong working knowledge of data integrity regulations and guidance (e.g. FDA EMA MHRA WHO).
- Proficiency in chromatographic software (e.g. Empower) and data analysis tools (e.g. Excel JMP).
- Excellent attention to detail organizational skills and communication abilities.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Hands-on experience with analytical instrumentation and lab operations preferred.
- Familiarity with inhalation drug delivery systems and aerosol testing is a plus.
- Experience supporting audit preparation and regulatory inspections is a plus.
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
Required Experience:
Senior IC
Employment Type
Full Time
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