Location
Foster, CA | United States
Job description
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare liver diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team: .
POSITION SUMMARY The Manager, Stability will manage and co-ordinate all aspects of stability studies for drug substance and drug product with CMO’s. Ensure that the stability protocols are approved, stability pulls are timely at the vendor sites and the stability data is updated and tracked in iStability data management and trending program. Additionally, the position will provide QC support for development programs and support creation and revision of specifications, CoAs, and batch disposition in Veeva QMS.
JOB FUNCTIONS/RESPONSIBILITIES - Manage migration of legacy data and new data input to iStability LIMS, stability data management and trending program
- Provide quality control oversight to contract testing laboratories
- Support product release, stability, raw materials, method lifecycle, reference standard qualification, and laboratory compliance for clinical and commercial products
- Provide technical review and trending of analytical data for drug substance, drug product, raw materials, and in-process testing while ensuring data integrity.
- Participation in the management of investigation, deviation, CAPA systems, and the Change Control process
- Manage batch genealogy, analytical data, certificates of analysis, reference standard inventory, and maintenance of specifications and test methods.
- Provide QC support for development programs and other Analytical Development activities.
- Provide support for regulatory submissions, queries and annual product reviews.
QUALIFICATIONS Education/Experience:
- Bachelor’s degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 4 years’ experience in QC oversight of pharmaceutical manufacturing in a global clinical and commercial environment
Knowledge, Skills and Abilities:
- Working knowledge of US and EU CGMP regulations and guidelines, quality system, regulatory, and industry standards at all phases of drug development with prior experience through commercialization is preferred.
- Working knowledge of trending and stability software is preferred.
- Practical knowledge of GMP and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release.
- Strong planning and time management skills and ability to prioritize own work.
- Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
- The ability to communicate clearly and precisely, both orally and in writing.
- Ability to problem solve, think critically, and troubleshoot while working independently.
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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
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