Sr. Director of Quality Control

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Akebia Therapeutics is seeking a candidate with proven ability to build and to lead the Quality Control department to support advancement and implementation of Akebia's Corporate drug development strategy and display a strong capacity for critical thinking and analytical reasoning. The Sr. Director is expected to build a cooperative and motivated internal and external team by coaching and development of staff and new analytical personnel. The Sr. Director will possess a broad, in-depth functional knowledge of the pharmaceutical industry across a variety of dosage forms that inspires confidence in decisions and recommendations. The Sr. Director will report directly to the Vice President of Quality and advise the VP on progress against critical timelines for a variety of quality initiatives.-- Required Skills The Sr. Director will build and implement processes to critically review, trend, and interpret analytical data of varying degrees of complexity generated to support corporate Quality or CMC initiatives, projects, and clinical/commercial programs. The Sr. Director will make defendable recommendations and decisions with Quality and other technical partners based on the data and will display an organized and independent thought process based on sound, logical thinking. Examples of recommendations include expiry extension, annual method assessments, release/stability data trending, specification setting, and identification and gaps in data to support regulatory filings. The Sr. Director will escalate, coordinate, and manage critical analytical investigations. Specifically, the Sr. Director will routine conduct data analysis and draft or oversee the completion of reports to support investigations, expiry extensions, risk assessments, and completion of critical regulatory requisites (e.g., the Annual Product Review).-- Importantly, in this role, the Sr. Director will oversee and manage the Akebia Global Stability Program for all Akebia clinical and commercial products as well as associated reference standards. These responsibilities will include enhancement of program infrastructure to continually meet global regulatory requirements, establishment of study requirements for all contract entities, oversight of program execution at all contract entities, and receipt, analysis, trending and interpretation of analytical stability data generated by contract entities. The incumbent will be responsible for oversight and completion of stability reports to support expiry extension and analytical investigations impacting the stability program. The Sr. Director will ensure that internal and external laboratories are capable of meeting Akebia's CMC expectations for both commercial and investigational pharmaceuticals by: 1) assuring testing meets industry and regulatory expectations/requirements; 2) establishing and maintaining Laboratory Systems (i.e. SOPs, training and documentation) supporting sample, standard and data management; 3) developing skill sets of internal QC personnel accountable for generating and reporting data with integrity, and; 4) aligning personnel and financial resources across competing timelines based on appropriate priorities. The incumbent will be responsible for oversight and support for analytical investigations to support the disposition of Akebia products and to support the Akebia's product portfolios and Global Stability Program. The Sr. Director of Quality Control will be the primary representative (or will identify the primary representative) for cross-functional teams and global initiatives for all Akebia products. The Sr. Director will maintain awareness of current industry regulatory expectations and requirements, effectively communicate those expectations throughout the organization, and assure that such requirements are appropriately integrated into analytical methods and procedures. The Sr. Director will strategically hire, develop, and build the Quality Control organization to support a growing pipeline as well as commercially established products. The incumbent will the leadership and expertise to develop staff as well as manage resource allocation in a rapidly changing environment. Domestic and international travel will likely be required (10-20%). Aptitude for digital meetings and cultural awareness will be essential to meet Akebia's globally-distributed testing platform. Required Experience Basic Qualifications:

• Bachelor's Degree--
• 10--years working in Pharma/Biotech Industry
• Management Experience
• Experience in implementing or maintaining GLP, cGMP and ICH requirements. Preferred Qualifications:
  • Bachelor's Degree in Chemistry, Biochemistry, Physics or Biology
  • Ph.D. in Biology, Chemistry, Analytical Chemistry preferred.
  • Awareness of other analytical techniques supporting compendial testing
  • Data trending, analysis and interpretation
  • Out of Specification / Out of Trend investigations
  • Data Integrity (ALCOA Principles)
  • Analytical Method Lifecycle Management including Development, Validation / Verification, and Transfer
  • Commercial product quality and regulatory requirements
  • Preparation of investigational or proposed commercial filings (e.g., IND, NDA, CTDs)
  • In-depth knowledge of HPLC / UPLC and GC Techniques
  • In-depth knowledge in UV/Vis, FTIR and ICP-MS Techniques
  • Exceptional written and oral skills Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living 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 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.

Keywords: Akebia Therapeutics, Inc., Cambridge , Sr. Director of Quality Control, Executive , Cambridge, Massachusetts