Director, External Manufacturing and Supply Chain bei Ardelyx
Ardelyx · Waltham, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Waltham
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
The Director of Supply Chain has oversight of assigned Ardelyx Supply Chain activities which include, Supplier Management and Oversite, Production Scheduling and Procurement. Key responsibilities include developing and executing manufacturing network strategy, overseeing supplier relationships, managing contract negotiations, and ensuring compliance with quality and regulatory standards. This role also involves strategic planning, cost management, and leading cross-functional teams to achieve operational excellence and meet business objectives.
Responsibilities:
- Build and maintain strategic and operational relationships with assigned CMOs
- Manage CMO manufacturing operations and deliverables to ensure supply of materials by disciplined tracking of activities for delivery against objectives, managing changes (documentation, alignment), and driving performance (metric setting, monitoring)
- Maintain financial responsibility for CMO and vendor spend, managing the budget allocation, negotiating work statements, documents for SOX compliance, inventory reconciliation, and other reporting requirements
- Track and supervise cycle times and provide any required associated reports and metrics
- Resolve supply issues with the CMO/Partner that affect product availability, including evaluating cost/benefit scenarios and making sound recommendations
- Oversee CMO due diligence during new CMO selection to vet capabilities, risks and investments required
- Identify and escalate business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions
- Establish alignment of objectives and priorities in close coordination with CMC team, clinical operations and other functions as needed, representing the CMO(s) in strategic decisions for the program
- Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Ardelxy and the CMO comply with commitments
- Develop strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives
- Maintain information flow during project execution from the Technical Operations team to enable monitoring of the relationships with CDMOs and other vendors
- Coordinate and manage CMO governance meetings, in partnership with CMO program manager and/or business lead
- Request proposals/quotes for required manufacturing services and work with Legal and other stakeholders to get them reviewed and approved
- Lead and/or participate in regular internal and external meetings to review schedule and communicate priorities
- Coordinate and lead quarterly business review meetings or other governance structures with API and drug-product CMOs to drive continuous improvement, with associated travel
Qualifications:
- BS/MS in Biology, Chemistry, Chemical/Biochemical Engineering or related scientific/technical discipline with 9 - 12+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development or equivalent experience
- Fluent in cGMP requirements
- Experience in working with third parties and CDMOs for manufacturing operations and supply chain management activities
- Ability to influence and effectively communicate and collaborate with senior management stakeholders both internally and externally
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Ability to execute and follow-through to completion
- Strong leadership and an innate ability to collaborate and build relationships is critical
The anticipated annualized base pay range for this full-time position is $198,000-$242,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
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