Associate Director, Continued Process Verification
CMC / Technical Operations
The Associate Director, Continued Process Verification is a strategic role that will help to align best practices of using data analytics and statistical analysis for technical and cross-functional/cross company business issues. This role is expected to provide in depth technical knowledge and leadership in data analytics and its application, especially in driving lean behavior, problem solving, preventative action, and continuous improvement. The position requires an experienced pharmaceutical scientist / with a proven track record of applying data analytics and continued process verification (CPV) to improve manufacturing and business processes.
This position will serve to drive implementation of Continued Process Verification. The ideal candidate will develop, implement, and drive improvement of data analytics and business processes as applied to continued process verification, including both process and method capability analysis. They will identify the greatest opportunities for product performance (capability, success rate/lot acceptance rate, and yield). The AD, CPV will work extensively with colleagues inside and outside Technical Operations to drive improvements to the design, execution, and communication of our progress in being proactive instead of reactive. The AD, CPV may lead high level cross functional teams utilizing project management skills to implement and improve key business processes and will oversee activities of lower level employees
- Develop and standardize complex statistical analysis techniques for product development, technology transfer and routine commercial product analyses.
- Make use of statistical software packages and other data manipulation software packages in the evaluation of Product Quality Review, in-process product, and special investigation data on a regular basis for all products.
- Lead teams through complex problem-solving methods, Stage 3 Continued Process Verification Regulatory expectations, and performs in-depth analysis of tangible and intangible factors to determine cause and effect.
- Work with other members of Technical Operations in designing and analyzing efficient experiments to optimize use of resources to collect information for investigations, validations, and process improvements.
- Design and develop statistical applications for use by others for ongoing monitoring and analysis of internal/external data (e.g. Validation, in-process controls, batch investigations, stability, and continued process verification).
- Work with colleagues within and outside Technical Operations to drive and embed improvements to the CPV process throughout the organization.
- Develop/support development of and implements sampling plans for materials.
- Analyze data from investigation evaluations, summarizes conclusions and makes recommendations for further work where necessary.
Generate quarterly CPV reports analyzing data from within Akebia’s supply network
B.S in Statistics, Engineering, Mathematics, or one of the life sciences is required and 10+ years of pharmaceutical industry experience
- A Master’s of Science Degree and 6+ years of pharmaceutical industry experience
- Pharmaceutical Development, Statistical/Data analytic support of commercial manufacturing and/or research experience
- Experience working with multiple manufacturing sites/laboratories, including contract manufacturing / laboratories is highly desired.
- Familiarity with data analytics tools
- Expert understanding of CPV and its applications
- Ability to understand and simplify complex processes
- Impact across both commercial and development programs
- Knowledge of cGMP, ICH and Regulatory CMC guidance documents specific to the role.
- Lean/six-sigma training and applications experience. Able to coach less experienced colleagues within the function
- Thorough knowledge of pharmaceutical testing
- Strong knowledge of the relevant cGMP, ICH and global Regulatory CMC guidance documents applicable to the function.
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with 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 Therapeutics 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.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Akebia for any position posted on our career page must have a current Akebia agency agreement executed by a member of the Human Resource Department. In addition, agencies may only submit candidates to positions for which they have been invited to do so by an Akebia Recruiter. All resumes submitted outside of these terms will not be considered.