Senior Director, Drug Substance
Company: Akebia Therapeutics
Location: Cambridge
Posted on: November 20, 2024
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Job Description:
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CMC / Technical Operations
Cambridge, MA
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ID:
24R-24
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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 commercial 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, all
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:
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, Marthas Vineyard , Senior Director, Drug Substance, Executive , Cambridge, Massachusetts
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