At miRagen Therapeutics, we aim to be a global leader in translating microRNA discoveries into breakthrough therapies that improve human health. We believe that by hiring the brightest, most talented individuals, people who share our passion for innovative science, we will be able to fulfill that mission. Our culture is one where creativity and teamwork are encouraged and success is celebrated. We engage our talented and diverse workforce through opportunities to do meaningful work and make a difference.
The Good Manufacturing Practices (GMP) Manager is responsible for the management of GMP systems and activities that align with corporate goals and comply with applicable regulations. The incumbent will work collaboratively with internal stakeholders to ensure compliance with policies and procedures and serve as a point of contact with CMO’s and vendors. Essential duties include:
• Conduct GMP-related vendor qualification audits;
• Work within a cross-functional team, ensuring compliance to regulatory guidance and internal document management standards;
• Work directly with CMO’s and other external contractors and collaborators, managing communication related to Manufacturing of drug substance, drug product, stability and other GMP related activities
• Review and approve Master Batch Records, Executed Batch Records, Deviations, CAPAs, OOS investigations, and Analytical Release Testing
• Review contractor investigations, deviations, and complaints; initiate necessary records according to company procedures
• Release of Drug Substance and Drug Product
• Review of analytical methods including method development, qualification and validation
• Create, track and maintain stability protocols and associated stability data for drug product and/or intermediates, including stability tables for regulatory submissions
• Review and approve labeling and packaging specifications, master records, and change control
Suitable candidates will possess a Bachelor’s degree in a Life Science or Engineering, and 8+ years of Quality Assurance experience in the Biotechnology and/or Pharmaceutical industry. Extensive knowledge of quality systems and regulatory standards at all phases of drug development is preferred.
• Clear understanding of FDA and international regulatory requirements;
• Ability to identify, evaluate, and close corrective/preventative action (CAPA) plans;
• Adept at prioritizing and completing tasks in a high-pressure environment;
• Proven leadership within a cross-functional project team;
• Ability to persuasively and effectively interact with partners, collaborators and CMO’s;
• Demonstrated ability to anticipate and address issues;
• Exceptional oral and written communication skills including excellent technical writing abilities.