Senior Director, Drug Substance

Senior Director, Drug Substance

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CMC / Technical Operations

Cambridge, MA

ID : 24R-24

Full-Time / Regular

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.

Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Reporting to the Vice President of Technical Operations, the Senior Director, Drug Substance will provide operational and strategic leadership to the Drug Substance organization within Technical Operations to support the development and optimization of Akebia's clinical and commercial programs.

Utilizing sound scientific principles, the Senior Director will assist in the development of program strategy and lead the activities for the identification of phase appropriate chemical process synthetic routes, ongoing clinical and commercial manufacturing processes development, identification of critical process parameters, process scale-up and technical transfers, validation, ongoing commercial support, and the oversight of contract drug substance manufacturing sites.

The Senior Director will directly support and be accountable for Akebia's pipeline of clinical and commercial programs to ensure timely delivery of clinical and commercial drug substance inventory.

The incumbent will support internal and external deviations / investigations, change controls, and authoring / review / approval of protocols, reports and relevant sections of clinical and commercial regulatory submissions (IND / IMPD, NDA / MAA) as well as the completion of commercial Annual Product Quality Reviews.

• Provide strategic, technical, and managerial leadership related to drug substance strategies for the development, optimization, scale-up, and manufacturing for Akebia's clinical and commercial programs.
• Lead project teams by providing oversight of project milestones, drive activities with additional project team members, manage timelines, contracts and invoices, and accountability for entire project.
• Collaborate with Akebia's Medicinal Chemistry group to support route scouting of research compounds, identify pre-Phase 1 process development / optimization opportunities, identification and determination of known and potential process impurities, and support the manufacturing of material to be utilized in GLP toxicology studies.
• Collaborate with Akebia cross-functional teams to support overall program strategies, goals and objectives.
• Manage and oversee activities at contract organizations worldwide to assure compliant and robust manufacturing processes are both developed and / or maintained.
• Responsible and accountable for the timely production of clinical and commercial drug inventory to support Akebia clinical programs and supply for established commercia programs.
• Author, review and approve technical protocols and reports.
• Review and approval of commercial process validation related documentation including validation plans, manufacturing stage specific protocols, and validation reports.
• Employing the principles of Continuous Process Verification (CPV), evaluate and analyze manufacturing data through the use of statistical tools to develop process understanding, establishment of critical process parameters and in-process controls, and the identification of process improvements.
• Hire, mentor and develop a world class drug substance organization by identifying experienced candidates and by providing coaching and feedback to all Drug substance personnel.
• Support regulatory submissions by writing / reviewing / approving drug substance related sections.
• Represent the Drug Substance organization on program teams.

Basic Qualifications :

Bachelor's, Master's, or Ph.D. Degree in Pharmaceutical Sciences, Organic Chemistry, Biochemistry, Chemical Engineering or a related scientific discipline.

15+ years of relevant industry experience with at least 5 years in a leadership position.

Preferred Qualifications :

Extensive knowledge and experience in the development and manufacture of small molecules

Strong problem-solving ability utilizing experience and data analysis to quickly drive scientifically sounds decisions and solve development and manufacturing issues quickly.

Well-developed knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.

Experience through all stages of the development lifecycle (Phase 1 through Validation), including leading commercial manufacturing oversight at contract manufacturing organizations.

Demonstrated acumen and program success with respect to phase appropriate chemical synthetic manufacturing processes supporting clinical and commercial programs.

Experience in managing activities at contract development and manufacturing organizations.

Ability to critically review and approve development and commercial documents (protocols, reports, batch records, regulatory filings) and extract relevant data for analysis and trending.

Experience in supporting global regulatory filings (IND, NDA, CTA, IMPD, MAA, etc.)

Up to 25% of time for international and domestic travel may be required.

Ability and desire to work in a fast-paced and dynamic environment.

Knowledgeable in GMPs and relevant regulatory requirements.

Demonstrated effective time management skills.

Sound judgment and commitment to ethical conduct.

Strong collaboration, team building and communication skills.

Compensation :

Targeted Base : 225,299 - 278,310*

Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown.

Base pay is only one component of the company's total rewards package, a ll regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity.

Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution.

Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease.

Want to learn more about what it means to be an Akebian? Visit our website : www.akebia.com

COVID 19 Vaccination : All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.

Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.

Please note that it is unlikely that accommodations can be granted for customer-facing positions.

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.