Technical Associate Director – Chemistry

Vantive • Oakdale, MN

4d • $176,000 - $239,000

About The Position

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 The Technical Associate Director – Chemistry role at Vantive R&D will provide technical project leadership in diverse areas of chemistry most relevant to our product portfolio. This leader will be responsible for orchestrating the execution of key technical activities pertaining to chemistry discipline (for on-market or new product development) through deep chemistry and domain expertise, innovation, collaboration, and problem-solving agile mindset. The Associate Director will work with their peers in R&D and cross-functional leaders (commercial, clinical, regulatory, quality and others) to prioritize strategic and tactical imperatives for chemistry discipline within Vantive. Given the critical role that chemistry plays in compliance of our drug products relative to global pharmacopeias (e.g., USP, EP, JP, BP), this role will have approximately 3 direct reports responsible for compendial monitoring and will act as Vantive’s leader for scientific liaising with such technical bodies. The Associate Director will establish and maintain a strong connection to external communities of experts in various areas within chemistry relevant to Vantive products – e.g., analytical chemistry, extractables and leachables, elemental impurities, mass spectroscopy, NMR, materials compliance, and stability of drug products. This individual will not only participate in such select committees but will also lead/chair key external committees acting as an influencer to drive thought leadership and shape forward looking standards for continued safety and efficacy of drug and devices for all patients across the globe. This external focus will enable this staff scientist to ensure that Vantive’s chemistry team is proactive and is using state-of-the-art techniques, tools, methods and instruments to solve challenging technical problems related to on-the-market or new products. This role reports to the Global Sr. Director for the Sciences function within Vantive R&D.

Requirements

• An educational background in Chemistry, pharmaceutical sciences or related areas is required for this role. A Master’s degree is required with 15+ years of relevant experience as described in the responsibilities section of our job description above.
• Strong knowledge and research/problem solving/technical leadership experience in multiple areas of chemistry (e.g., analytical chemistry, Stability, Extractables and Leachables, Mass spectroscopy, Nuclear Magnetic Resonance, Elemental Impurities, and/or Materials compliance).
• An expert in at least one of these specialties within Chemistry, as applied to drugs and devices.
• Direct work experience as a scientist and/or a project leader for projects involving chemical investigations, analytical method validations, changes to existing products, and development of new drug products
• Demonstrated experience and expertise to develop and use approaches that are compliant with regulations and can be streamlined in an industry setting in a scientifically justified manner

Nice To Haves

• A Ph.D. with 12+ years of relevant experience as described in the qualifications section
• Strong knowledge of general quality and business systems
• Strong mentoring, effective communication, and strong decision-making skills
• Self-motivated, with excellent interpersonal skills, and an ability to solve complex problems through innovative methods and approaches

Responsibilities

• Prioritize, direct, and own a few critical chemistry activities across a number of strategic (or at times tactical) projects. The work may be tied to existing products on the market or new product development. Typical projects will involve activities pertaining to one or more of the following e.g., analytical method development, chemical investigations, structure elucidation for impurities and drugs, streamlining chemistry approaches in a manufacturing setting etc.
• Maintain understanding of relevant internal and external drivers of the future vision of our product portfolio. Considerations will include patient/therapy, regulatory/compliance, global/regional competition, and more.
• Develop and Maintain Chemistry technology roadmap for Vantive.
• Lead a small team scientists and document specialists to ensure compliance to global pharmacopoeia through regular compendial monitoring and discussion/interactions with the relevant authorities (e.g., USP, EP, BP and JP)
• Proactively engage in the scoping, ideation, concept selection, and other key development decisions for all drug and device products with specific focus identifying how chemistry discipline can enable such vision through expertise and innovation
• Coach the organization on the state-of-the-art chemistry tools and connect individual team members’ role to achieving our vision and projects
• Establish and maintain internal and external networks of technical experts in relevant or adjacent competencies. Participate in relevant standards committees and influence guidelines in support of our patients.
• Act as a thought leader in global R&D community by encouraging and enabling participation of their team members in external working groups that define & influence technical direction of chemistry and help shape regulatory frameworks
• Collaborate and work closely with peers e.g. R&D functional leaders for areas like Analytical Chemistry, Sterility, E&L, materials, and Preclinical to align R&D goals and strategy so as to meet project and organization goals in a most efficient and effective manner
• Collaborate and influence cross-functional peers and senior leaders in product design, regulatory, medical affairs, legal, commercial, and quality to achieve organizational goal to providing safe drug and medical device products to our global patient population
• Mentor R&D members in chemistry discipline in areas such as scientific excellence, innovation, and internal and external influence, ensuring their developing expertise aligns both with their career interests and with business needs
• Maintain current knowledge of Quality System Regulations and other relevant regulatory requirements

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director