Associate Director, Continuous Process Verification ? CMC /
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
Required Skills 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
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
Develop/support development of and implements sampling plans for
Analyze data from investigation evaluations, summarizes
conclusions and makes recommendations for further work where
Generate quarterly CPV reports analyzing data from within
Akebia’s supply network
Required Experience Basic Qualifications:
B.S in Statistics, Engineering, Mathematics, or one of the life
sciences is required and 10+ years of pharmaceutical industry
A Master’s of Science Degree and 6+ years of pharmaceutical
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.