Scientific Pharmacopeial Liaison

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 successful candidate in this role will work closely with global cross functional teams (R&D scientists (e.g., compendial monitoring, analytical chemistry, PDOs, and preclinical experts), ISC, Quality, and Regulatory) to ensure compliance with various pharmacopoeias. The individual will identify, define, and lead change controls and / or proposed initiatives required to ensure compliance of Vantive’s manufacturing and testing of drug products produced in 10+ manufacturing plants around the world. This role is a liaison across compendial global monitoring function, R&D scientists, and quality & chemistry personnel across Vantive’s manufacturing footprint as well as a liaison between Vantive and global pharmacopeia.

What you'll be doing

• Work with Compendial Monitoring team members to identify updates from USP, BP, EP and Pharm Europa compendial websites that are relevant to Vantive’s drug products.
• For the updates identified as above, the Scientific Pharmacopeial Liaison will first perform gap analysis to define potential gaps the updates create for various Vantive products and manufacturing sites. Towards this effect, this liaison will work closely with PDOs, plant quality and plant chemistry teams in addition to R&D chemistry and preclinical teams.
• Post gap analysis, the liaison will work with individual plants to define a plan in the context of change control (if appropriate).
• As agreed to with the plants (depending on nature, complexity and scope of changes needed), the liaison may either own the change control and/or own technical execution plan for such change controls. The individual will articulate step-by-step analytical chemistry method development and validation as needed, acting as an analytical lead for such changes.
• The liaison will have an external facing component of their role wherein the liaison will collect feedback on any published pharmacopeia updates from all Vantive stakeholders and will compile a cohesive and cogent response to the pharmacopeia. The liaison may work directly with the pharmacopeia or go through senior members of technical staff in Vantive to ensure that Vantive’s voice is heard, and the enforced updates do not result in unnecessary and expensive CMC burden on Vantive while continuing to ensure patient safety.
• Be highly proficient and efficient in review/revision of product raw material, and test method assay documentation.
• Will lead and execute preparation/creation of product documentation and document change control package development.

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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