Research Associate III - Stability SME at Vontive

Castlebar, County Mayo, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Healthcare, Kidney CareIndustries

Requirements

Bachelor’s Degree with 5-7 years of relevant experience (or Master’s with implied equivalent experience)
Sound chemistry and stability planning expertise
Ability to apply expertise to identify and resolve stability indicating characteristics
Capability to develop and design non-routine strategies and recommendations addressing technical, regulatory, and business requirements

Responsibilities

Represent R&D–Stability on project teams as a key member contributing to goals and success
Craft and implement stability strategy plans for new product development and sustaining projects
Design GMP stability studies used to establish expiration dating for product development
Contribute to the development of technical justifications for expiration dating for new or modified products and defend recommendations to key business partners
Provide input to stability assessments and requirements for new products and/or current product changes
Ensure appropriate methods and specifications are available for stability, compatibility, and release testing over shelf life
Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches, providing sound scientific rationale
Interact with manufacturing facilities to acquire information related to test methods and specifications
Author, review, and verify technical data, protocols, and reports
Act as study director for stability projects under guidance of senior Stability team members
Perform stability study administration activities on LIMS, including study building and review, identification of product test data requiring modification, and data entry
Develop new and/or optimize existing processes and procedures to enhance stability related practices
Participate in investigations for atypical or out-of-specification/out-of-trend test results; review data and author technical evaluations characterizing stability trending
Leverage critical thinking to drive investigations to conclusions based on sound scientific principles
Plan, coordinate, and oversee multiple Stability related projects, budgets, and activities with global teams and CROs as applicable
Contribute to and/or take lead author role for stability sections in regulatory submissions; use computerized systems to retrieve, evaluate, and summarize data for reporting

Skills

Key technologies and capabilities for this role

ChemistryStability PlanningGMPStability StudiesShelf Life DeterminationProduct QualificationR&DRegulatory Compliance

Questions & Answers

Common questions about this position

What is the employment type for this Research Associate III position?

This is a full-time position.

Is this role remote or does it require on-site work?

This information is not specified in the job description.

What key skills are required for the Research Associate III - Stability SME role?

The role requires sound chemistry and stability planning expertise, ability to design GMP stability studies, and skills in developing technical justifications for expiration dating. Additional skills include risk identification, scientific rationale provision, and authoring technical data, protocols, and reports.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocre and are driven to improve patients' lives worldwide through meaningful innovations in vital organ therapies.

What makes a strong candidate for this Stability SME position?

Strong candidates will have expertise as a Stability Subject Matter Expert, experience representing R&D-Stability on project teams, and the ability to craft stability strategies addressing technical, regulatory, and business needs.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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