Testing Coordinator/Research Associate Iii

2+ years

Not Disclosed

Plymouth Meeting

10 Nov. 20, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only strengthen our leadership in kidney care but also offer meaningful work to those who join us.

At Vantive, you will be part of a community of people who are focused, courageous, and refuse to settle for mediocrity. We are driven to improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to customary regulatory approvals and satisfaction of other closing conditions.

Your Role at Vantive

The Renal Solutions and Containers - Analytical Chemistry and Stability team supports Renal Care and Acute Therapy R&D projects. We are currently seeking a Stability Study Coordinator to own operational excellence and continuous improvement. This role will involve streamlining processes, coordinating business, management, and technical SMEs, identifying risks, and devising solutions to support the establishment of shelf life for both new and existing products.

The successful candidate will contribute solid technical knowledge across various projects with minimal assistance and demonstrate a basic understanding of related fields, focusing on innovation, process improvement, and operational excellence.

What You'll Be Doing

Process inputs from Global Stability Functional Leader and Stability SMEs to resolve schedules and forecast resource allocations for projects.
Ensure the right methods and specifications are available for stability testing.
Coordinate testing with global teams and CROs as applicable.
Collaborate with other functions such as project management, regulatory, extractables, manufacturing, and quality in project teams.
Participate in detailed planning of Registration Stability Test lab, and, if approved, lead the implementation.
Participate in investigations that correspond to atypical or out-of-specification/out-of-trend results. Review data and author technical evaluations on stability trending.
Independently plan, implement, and lead projects/programs across multiple subject areas, utilizing established methods, techniques, or approaches.
Maintain and update equipment and analytical procedures.
Stay current with relevant Quality System Regulations and other regulatory requirements to ensure compliance in all research, data collection, and reporting activities.

What You'll Bring

Experience with analytical method development, validation, and transfer.
A good understanding of ICH, USP guidelines, and cGxP practice.
Experience with instruments such as ICP-MS, ICP-OES, IC, AA, UHPLC/HPLC, GC, UV, Polarimeter (NMR is a plus).
A logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
Basic understanding of analytical chemistry, both theoretical knowledge and practical experience.
Understanding of manufacturing documents and strong time management and project management skills.
Functional understanding of FDA, ISO, and Quality systems.

Education and/or Experience

Bachelor’s Degree with 5+ years of experience, Master’s Degree with 3+ years of experience, or PhD with 1+ years of experience in chemistry.
Analytical lab experience, cGxP experience, and cross-functional teamwork.
Independent experimentation in method development and validation.

What We Offer

Flexible workplace policy, with a minimum of 3 days a week onsite.
Competitive total compensation package.
Opportunities for professional development.
Commitment to work-life balance and inclusive workforce development.

Base Salary Range:
Estimated salary for this position is $96,000 to $132,000 annually. Individual pay will be based on factors such as location, skills, experience, and market data.

Reasonable Accommodations

Vantive is committed to providing reasonable accommodations to individuals with disabilities during the application or interview process. Please contact us if you need assistance.

Recruitment Fraud Notice

Vantive has discovered incidents of fraudulent parties posing as employees, recruiters, or agents. These parties attempt to steal personal or financial information. Please review our Recruitment Fraud Notice to learn how to protect yourself.

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Testing Coordinator/Research Associate Iii

Job Description

Your Role at Vantive

What You'll Be Doing

What You'll Bring

Education and/or Experience

What We Offer

Reasonable Accommodations

Recruitment Fraud Notice

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