The Director of Stability is responsible for the management, coordination. And oversight of internal and external stability activities related to both Drug Substance and Drug Product as part of all stages of the product lifecycle for the Akebia product portfolio. The role will interact with Quality Assurance, Quality Control, and CMC development and commercial organizations to manage and to oversee the stability program at all Akebia contract manufacturing sites. The incumbent will effectively management resources for the stability group, plan and execute projects to agreed timelines, and strive to implement efficient, effective, and compliant processes.
Required Skills
- Liaise with the Quality and CMC organizations to initiate and to maintain stability studies related to all Akebia clinical and commercial programs.
- Draft, review and approve of stability studies and assure compliance with ICH guidelines and relevant global regulatory requirements.
- Provide oversight to the contract testing laboratories including review of the analytical stability data generated by the testing laboratory.
- Establish and maintain quality metrics related to the stability program.
- Investigate and/or provide guidance, input and oversight for OOS or OOT results related to the stability program.
- Optimize and maintain the Akebia stability program for Drug Substance and Drug Product including development and execution of stability protocols/schedules, plans, follow-up, tracking, trending, and reporting.
- Ensure statistical analysis and routine trending of the stability data is performed, is accurate and meets expectations for drug substance and drug product stability programs
- Support the preparation, review and approval of the Annual Product Review and Annual Report as it relates to the Akebia stability program.
- Coordinate quarterly, or as requested, review of stability data to ensure products remain supportive of a retest or expiry date.
- Draft, review, and/or approve stability reports for retest and expiry extension for clinical and commercial Akebia products.
- Coordinate the QA oversight of the stability program at Drug Product and Drug Substance contract testing and manufacturing sites or internally, as applicable, of Akebia products.
- Review stability plans, testing data, and reports to ensure conformance to established Quality processes and standards.
- Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to Drug Substance and Drug Product stability program.
- Responsible for supporting GMP vendor stability qualification processes including overseeing or participating in the audit of those vendors.
- Manage and develop a team of contractors and/or internal resources/staff
Required Experience
Basic Qualifications
- Bachelor degree
- 8+ years experience in biotechnology or pharmaceutical industry
- Supervisory or managerial experience
- 5+ years’ experience in Drug Substance and Drug Product stability with experience in both paper and electronic based systems.
Preferred Qualifications:
- Experience in statistical review of data
- Ability to work effectively cross functionally
- Familiar with electronic data storage regulatory requirements
- Experience in helping to build and maintain a Quality infrastructure for a Drug Substance and Drug Product analytical and stability program in a fast-paced growing company
- Experience in dealing with both US and EU stability requirements. Experience with requirements in Japan a plus
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.