Research Associate III - Materials

Vantive Manufacturing • Plymouth, VA

10d • $96,000 - $120,000 • Hybrid

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: In this role, you will be part of materials and chemical characterization team and will bring hands-on technical experience in material selection, material sustainability, compendial testing – in particular for polymeric materials – pertinent to use in drug and device industry. This Research Associate role will entail utilization of expertise in materials science to perform gap assessments for medical device requirements and support change control activities across the Renal and Acute Care businesses within Vantive. Additional responsibilities include providing input to regulatory, product sustaining, and product development strategies from the perspective of materials science and polymer science. This role may include laboratory work in materials characterization and independent execution of laboratory studies. You will lead design and development of material testing for multiple projects (e.g., New Product Development &/or Change controls related to supplier notifications) at in-house labs and/or coordinate the testing with external testing houses. The individual will author required reports (internal documentation and regulatory submissions) following pertinent internal and external guidelines that enable the eventual use of materials in drugs or devices that Vantive makes.

Requirements

• Bachelor’s degree in a relevant field (e.g., Chemistry, material science, materials or chemical engineering with emphasis of polymeric material science) with minimum of 8 years relevant experience (e.g., material selection for applications in a regulatory environment) or Master’s Degree with minimum of 5 years relevant experience, or Ph.D. with minimum of 3 years relevant experience.
• Prior experience in Medical Device/Pharmaceutical/Aerospace/Chemical Industry
• Demonstrate high level of passion and interest in material science, chemistry, and applications of that knowledge to be an effective problem solver in an industrial setting
• Excellent written and verbal communication skills in English
• Ability to effectively contribute as an integral member of a project team
• Ability to objectively assess, organize, and clearly communicate information
• Ability to interpret available information and make recommendations to resolve technical challenges and address business issues
• Ability to appropriately prioritize work assigned to meet project deliverables in a timely manner.
• Demonstrate inclusive attitude, collaborate with team members and cross-functional teams for project deliverables.

Responsibilities

• With minimal or no assistance or technical supervision, perform technical analysis of materials incorporated into design of simple and complex medical devices.
• Determine and communicate whether and how the materials in the design meet regulatory and product requirements.
• Lead material selection activities including compendial testing activities.
• Lead material testing & qualification at in-house or external laboratories in order to enable usage of the materials tested in drug and/or medical device products.
• Lead and/or coordinate EP, USP compliance testing on disposables (e.g. filters, dialyzers, polymeric connectors etc.), packaging, and container closure materials and container systems.
• Communicate effectively with internal stakeholders – e.g., technical SMEs, products owners as well as product management; participate and contribute to materials strategy discussions and provide technical assessments for near & long terms strategic imperatives.
• Support the development and execution of strategies for subject matter expertise in materials characterization and assessment across business unit.
• Conduct routine and non-routine research assignments to advance internal knowledge of materials and associated needs for product development and product lifecycle management.
• Partner with colleagues in matters of subject expertise and participate in non-routine investigations to trouble-shoot and investigate challenges in the field and in product development.
• Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks.
• Employ appropriate techniques/methods including extensive data analysis of literature and/or lab-generated data to execute assignments successfully and independently within negotiated deadlines.
• Write comprehensive protocols and reports.
• Maintain knowledge of and apply relevant quality and safety requirements including equipment ownership and qualification.
• Have and/or build strong knowledge and understanding of GDP, GLP, GMP and related regulations and guidelines.

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: Mid Level