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Scientist II

23 March 2022

ABOUT NOVEOME BIOTHERAPEUTICS, INC.

Noveome Biotherapeutics, Inc. is a dynamic biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug tdevelopment. Unlike most drugs that are single molecules directed at specific indications, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

 POSITION OBJECTIVE

The Research & Development Scientist II is responsible for organizing and executing research and development projects in an effort to achieve department objectives within the specified project timelines.  This position develops cell based biochemical analytical assays, executes laboratory experiments, and presents data to management and cross functional project teams.  This Research & Development Scientist II will assist in guiding the work of Research and Development personnel as well as develop strategies for product and process transfers to Quality Assurance and Manufacturing.

 WHAT YOU WILL DO FOR NOVEOME

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Develops and initiates assays and experiments determined by the current indications and projects approved by management.
  • Participates in the design and assists in the execution of experiments and preclinical studies.
  • Performs a data analysis review and interprets the results of experiments and assays.
  • Troubleshoots assays and experiments, identifies problems, and initiates plans to resolve the issues.
  • Monitors research and development inventory and budget.
  • Analyzes reports including results summaries related to assay qualification, research experiments, Investigational New Drug (IND) submissions, regulatory agency guidelines, grant opportunities, and publications.
  • Updates management on various projects as they may relate to manufacturing, research, development or preclinical studies.
  • Participates in research and development team meetings as well as interdisciplinary meetings regarding current and upcoming projects.
  • Trains Associate Scientist and Technician positions in processes and experiment design.
  • Provides analytical testing support for new dosage forms. Works closely and lead analytical scientists in analytical method development and drug product stability assessment.
  • Develops strategies for product and process transfers to Quality Control and Manufacturing, process scale-up activities, and clinical supplies manufacture.
  • Develops cell-based assays to be used in target validation studies and medium throughput screening campaigns.
  • Executes bioanalytical experiments, supports pre-clinical efforts by designing and conducting laboratory studies, actively contributes to project and program teams and provides clear and consistent communication of ideas, data, conclusions and outcomes.

Please note, as a company rooted in innovation, our positions are consistently evolving and we champion the development of all roles.  This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

 

REQUIRED QUALIFICATIONS

  • Research related to drug mechanism of action (MOA) experience
  • Assay development experience
  • Preclinical studies to test drug efficacy experience
  • Manufacturing and process improvement testing experience
  • ELISA
  • Assay qualification and validation
  • Gel electrophoresis
  • Western blotting
  • qPCR, flow cytometry
  • Microsoft Office Excel, PowerPoint, Word, Outlook
  • Luminex

BENEFICIAL QUALIFICATIONS

  • Evidence of independent research
  • Current Good Manufacturing Practices (cGMP) knowledge
  • High Pressure Liquid Chromotography (HPLC)
  • Ultra Performance Liquid Chromotography (UPLC) based methods
  • Design of Experiments (DOE) methodology
  • Bioanalytics
  • Experience with scale-up and process modeling
  • GMP Part II 21CFR experience

ATTRIBUTES OF SUCCESS

Results Driven                      Creativity                               Collaboration                        Integrity                 Adaptability

Critical Thinking                   Accountability                      Optimization                         Independence      Interactive Communication

 

WORK ENVIRONMENT/PHYSICAL DEMANDS

Requires a combination of sedentary work and standing for extended periods of time in the Research labs where personal protective equipment is required.  Duties require fine finger dexterity, writing, typing, hearing, reading, and depth perception.

 REGULAR SCHEDULE

This is a salaried full-time position with a regular schedule of Monday through Friday work hours.  Extended hours may be needed on occasion to complete company objectives. This position requires the incumbent to be physically present onsite.

 WHAT NOVEOME WILL DO FOR YOU

Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment.

LOCATION- PITTSBURGH

REPORTS TO- RESEARCH & DEVELOPMENT DIRECTOR

MANAGES OTHERS- NO

EDUCATION/YEARS’ EXPERIENCE- PHD WITH 1+ YEARS, MASTERS WITH 4+ YEARS, OR BACHELOR’S WITH 6+ YEARS

RELATED DEGREE PROGRAMS- PHARMACEUTICAL SCIENCES, CHEMISTRY, BIOCHEMISTRY, IMMUNOLOGY, MOLECULAR BIOLOGY, BIOMEDICAL ENGINEERING

YEARS’ EXPERIENCE REQUIREMENTS- ACADEMIC RESEARCH OR INDUSTRY LAB EXPERIENCE, 2+ YEARS’ MANAGING PROJECTS

A combination of experience and/or education will be taken into consideration.

 

Noveome is an Equal Opportunity Employer.

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