Sr. Scientist, Analytical Development/Data Reviewer

MannKind Corporation

  • Danbury, CT
  • $92,000-138,000 per year
  • Permanent
  • Full-time
  • 1 month ago
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.
  • Bachelor's 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 recruiting@mannkindcorp.com.Pay Range: $92,000 - $138,000 per year

MannKind Corporation