Vivex Jobs (NOW HIRING)

Description

Under the direction of the Director of Research, the Research Scientist is responsible for designing, executing, and documenting research activities supporting human tissue-based product development, product characterization, and translational performance testing. This role contributes to the development and evaluation of tissue allografts through experimental design, biochemical and biomechanical characterization, ex-vivo model development, data analysis, and cross-functional collaboration with Research, Quality, Regulatory, Operations, and Marketing teams.

Ideal candidate profile: Scientist with prior human tissue/allograft experience with the   ability to develop testing (biomechanical, functional, or ex-vivo models) to   evaluate tissue characteristics, handling and performance.

Requirements

   
Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship. 

Duties and Responsibilities

Design, execute, and document research studies supporting the development, characterization, and performance evaluation of human tissue-based products, including literature review, experimental design, sample selection, test method development, complex laboratory testing, data analysis, and interpretation of results.

Develop, optimize, and execute biomechanical, functional, and ex-vivo test models to evaluate tissue properties, handling characteristics, structural performance, and product-use conditions. 

Analyze and interpret research data using appropriate statistical and scientific methods, and prepare clear technical summaries, internal reports, protocols, presentations, and manuscripts as needed. 

Support product development activities by identifying relevant critical material attributes, product performance attributes, and test methods for tissue-based products. 

Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Commercial teams to support product claims, technical justifications, design inputs, risk assessments, and regulatory strategy. 

Required Qualifications

• Advanced degree (Master's, PhD) in Biochemistry, Chemical Biology, Bioengineering or life sciences/health related field. 
• Prior hands-on experience with human tissue, allografts, extracellular matrix-based materials, or biologically derived implants is strongly preferred. 
• Experience designing and executing independent laboratory experiments, including study planning, protocol development, data analysis, and technical reporting.
• Experience with tissue characterization methods, which may include biochemical assays, histology, microscopy, ELISA, flow cytometry, cell-based assays, tissue culture, extracellular matrix analysis, or related techniques.
• Experience with biomechanical testing, functional performance testing, or ex-vivo model      development is strongly preferred.
• Strong technical writing skills, including the ability to prepare protocols, study reports, technical summaries, literature reviews, and scientific presentations.
• Strong organizational skills with the ability to manage multiple projects, timelines, and experimental priorities.
• Ability to work effectively in a laboratory environment and collaborate with      cross-functional teams.
• CTBS certification or ability to obtain certification within two years of employment.

Preferred Qualifications

Experience supporting regulated product development in an FDA-regulated environment, preferably involving human tissue products, HCT/Ps, biologics, medical devices, or combination products, including product characterization, verification testing, technical documentation, and cross-functional support for Quality and Regulatory activities.

Experience working with musculoskeletal, birth tissue, cartilage, intervertebral disc, bone, connective tissue, or other structural tissue matrices.

Experience developing or executing biomechanical assays such as compression, tensile, shear, swelling, hydration, viscoelastic, injectability, extrusion, retention, or handling-related testing.

Direct Reports

This position may supervise one Research Associate and may be responsible for assigning work, providing technical guidance, supporting training, reviewing experimental documentation, and ensuring completion of research activities in alignment with project objectives and laboratory procedures.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time.

VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

VIVEX Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.