Associate Director, Analytical Development
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Position Summary:
We are seeking an experienced and strategic Associate Director Analytical Development to lead the execution of small molecule analytical activities across clinical and commercial programs. This role partners closely with the Director to shape and implement analytical strategies while driving day-to-day execution through external partners.
The Associate Director provides technical leadership across analytical activities ensures alignment with regulatory expectations and contributes to the progression of programs from early development through commercialization. This role collaborates cross-functionally with CMC Quality Regulatory and external partners to ensure timely and high-quality deliverables.
This is a hybrid role (2-3 days in office) at our Waltham MA headquarters.
Responsibilities:
- Lead execution of phase-appropriate analytical development strategies in alignment with Director guidance for external partners (CMOs/CROs) ensuring quality timelines and alignment with program goals
- Oversee analytical method development qualification validation and transfer activities to support clinical and commercial programs
- Partner cross-functionally and external analytical partners to advance programs escalating risks and proposing solutions proactively
- Provide technical review and guidance on analytical data protocols and reports to ensure scientific rigor and compliance
- Participate in the author and review of analytical sections of regulatory submissions (INDs NDAs) in collaboration with senior leadership
- Represent the Analytical Development function on various cross-functional project teams including internal project teams as well as third-party analytical and manufacturing teams
- Ensure analytical activities are aligned with regulatory expectations and internal quality standards
- Contribute to continuous improvement initiatives including processes workflows and vendor management practices
Qualifications:
- B.S. in chemistry or related discipline with 9 years of industry or equivalent experience
- Demonstrated small molecule experience in analytical method development and validation as well as associated regulatory requirements
- Experience working in close collaboration with technical regulatory quality assurance project management and supply chain functions in a cGMP operational environment
- Experience in managing outsourced Analytical Development activities
- Experience in preparing regulatory documents including briefing books for regulatory meetings INDs and NDAs
- Excellent communication skills and the ability to present to internal and external audiences
- Strong understanding of cGMP requirements and quality systems related to analytical development activities
- Periodic travel to manufacturing and other partner sites (approximately 10% of time)
The anticipated annualized base pay range for this full-time position is $183000 - $223000 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.
Required Experience:
Director
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
