Associate Director - Global Chemistry Laboratory Operations & Governance

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role:

This Associate Director -Global Chemistry Laboratory Operations & Governancerole at Vantive R&D provides technical, people, and compliance leadership for chemistry activities most relevant to Vantive's global drug and device product portfolio.

This role has direct people, laboratory, and project execution responsibility for US-based chemistry laboratories, leading a wet chemistry team of approximately 8-10 scientists performing extractables and leachables (E&L), analytical chemistry, stability, and materials compliance testing as well as data scientist(s) for data analysis and digital tools specialist(s) for streamlining lab workflows.

In addition, this role holds global accountability for governance of chemistry laboratory (which would cover analytical chemistry, stability, extractables and leachables (E&L), and materials compliance testing labs) compliance across all internal and external laboratories supporting Vantive products. This would include Vantive internal labs in US, Ireland and India and external Contract Research labs (CROs) across the globe. The Associate Director serves as the primary R&D interface with Regulatory and Quality functions for all chemistry laboratory-related matters globally, and as the primary compliance interface with all external chemistry laboratories, contract testing organizations, and other related suppliers.

The role orchestrates execution of critical chemistry activities through deep domain expertise in chemistry applications in drug and device product portfolio, a strong compliance mindset, cross-functional collaboration, and an agile, problem-solving approach. This individual works closely with R&D peers and cross-functional leaders to ensure chemistry strategies enable compliant, safe, and effective products for global patients.

What you'll be doing:

• Provide direct people leadership for a US-based wet chemistry laboratory team (~8-10 scientists) performing extractables and leachables (E&L), analytical chemistry, stability, and materials compliance testing.
• Own global governance of chemistry laboratory compliance (e.g., GMP) for all laboratories supporting Vantive products.
• Serve as the primary and accountable R&D interface with Regulatory Affairs and Quality functions for all chemistry laboratory-related matters globally.
• Act as the primary global technical and compliance interface with all external chemistry laboratories, contract research/testing organizations, and analytical suppliers.
• Prioritize, direct, and personally own critical chemistry activities across strategic and tactical projects being executed in US chemistry labs supporting both on-market products and new product development.
• Ensure inspection of readiness for chemistry laboratories and support audits, inspections, and regulatory interactions involving internal and external laboratories.
• Contribute to and maintain the Chemistry and Laboratory Technology Roadmap.
• Work with cross-functionalstakeholders and peers to design and implement laboratory strategy across extractables and leachables, analytical chemistry, stability, and materials compliance.
• Proactively engage in scoping, ideation, and key product development decisions.
• Coach and mentor laboratory scientists to foster a culture of scientific excellence, compliance, collaboration, and continuous improvement.
• Collaborate closely with R&D peers and cross-functional stakeholders on strategy, resource allocations, and program execution.

What you'll bring:

• A Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related STEM disciplines is required.
• 15+ years of relevant experience, including significant experience in regulated laboratory environments (e.g., GMP) and interaction with internal regulatory and quality organizations as well as governmental agencies like FDA, EMA for drug and device product portfolio.
• Demonstrated hands-on (in at least one of the areas) and leadership expertise in extractables and leachables (E&L), analytical chemistry, stability, and materials compliance within regulated laboratory environments.
• Strong working knowledge of global regulatory and quality expectations (e.g., cGMP) applicable to chemistry laboratories and external testing organizations.
• Proven experience leading laboratory-based scientists and setting technical direction in a wet chemistry environment.
• Demonstrated experience acting as a senior technical interface with Regulatory Affairs, Quality, external laboratories or suppliers and government regulatory bodies like FDA, EMA, and others.
• Hands-on experience supporting analytical method development and validation, stability programs, chemical investigations, and materials compliance testing.
• Ability to design and implement scientifically sound, regulation-compliant, and operationally efficient laboratory strategies.
• Strong communication, mentoring, and decision-making skills.
• Self-motivated, collaborative leader with strong interpersonal and problem-solving skills.
• Leadership experience managing teams of around 10 or more is required.
• Demonstrated experience in working in global teams - especially in people leadership and/or strategic leadership roles is highly desired.
• The successful candidate will demonstrate a passion for advancing scientific innovation in a highly regulated environment, consistently seeking opportunities to optimize laboratory operations and support new product development initiatives. They will thrive in a collaborative setting, leveraging their technical, compliance, and leadership skills to drive continuous improvement and contribute to the achievement of organizational goals. Adaptability, strategic vision, and the ability to build strong relationships across global teams will be essential to ensure the ongoing success and compliance of Vantive's chemistry laboratories.

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $176,000 to $220,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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