RAIII 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.

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.

Essential Duties and Responsibilities:

• 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.
• Perform gap analysis to define potential gaps the updates create for various Vantive products and manufacturing sites.
• Post gap analysis, the liaison will work with individual plants to define a plan in the context of change control (if appropriate).
• As agreed 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 collect feedback on any published pharmacopeia updates from all Vantive stakeholders and will compile a cohesive and cogent response to the pharmacopeia.
• Will lead and execute preparation/creation of product documentation and document change control package development.
• Monitor/track changes through TrackWise 8 change control system. Follow up with change assessors.
• Prepare redlined documents and upload completed documents into appropriate systems.
• Perform/assist in internal document assessments by collecting, organizing, summarizing, and analyzing information as requested.
• Assist in training staff, internal and external customers on documentation processes and systems.
• External influence: actively participate in external organizations such as compendial discussion groups.

Qualifications:

• Highly proficient in quality documentation systems.
• Previous hands-on experience in analytical chemistry labs in a pharmaceutical setting is a must for this role.
• Demonstrated experience in working in global teams.
• Past experience of working with high daily dose drug products in liquid form (e.g., parenteral or IV drug products) is a plus.
• Advanced proficiency in Word, Excel, Team Center for documentation, and TrackWise 8 software systems.
• Familiarity with technical matters in the space of drug products and medical devices.
• Excellent verbal and written communication skills in English.
• Ability to work under strict deadlines amidst changing priorities with minimal supervision.
• Aware of FDA regulations, application of Good Laboratory Practices and Good Manufacturing practices
• Good project management skills.
• Ability to provide and accept critical feedback from others in a constructive manner.

Education and/or Experience:

• B.S. in Chemistry with 7 or more years of relevant experience (hands-on experience in most of these roles - e.g., Analytical chemist, Quality control chemist, analytical lead, change control owner for analytical method changes is a must) in a drug product company – either in R&D, Regulatory, Manufacturing and/or Quality functions.
• Experience working with cross functional global teams and willingness to work efficiently across multiple time zones to support global manufacturing footprint of Vantive.
• Experience working with physical and chemical testing of routine in-process and finished products in cGMP quality environment.
• Knowledge of product/document configuration management.
• Working knowledge of related business systems – including software, databases and quality systems.

What Vantive can offer to you:

• A permanent contract with a stable and secure work environment.
• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
• A collaborative and dynamic work environment.
• Access to state-of-the-art equipment and technology.
• Recognition and reward for outstanding performance.

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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