Clinical Research Scientist

2 months ago

Hopewell Township, United States LanceSoft, Inc. Full time

Title: Process Modeling Specialist

Location: Titusville, NJ - Hybrid schedule (2-3 days onsite)

Duration: 1 year


HM Notes:

  • Role will be Hybrid in Titusville
  • Title of the role could be "Process Modeling Specialist"
  • Bachelor's degree
  • Will provide technical support for a manufacturing site
  • Use processes and modeling for the role
  • Must have data scientist exp
  • Work with data coming from systems
  • Use coding to transfer the data to better explain the process performance to leaders
  • Must have visualization exp
  • Must have Report Writing exp
  • Must have Statistic and Analytical exp (ex: ANOVA, Regression, etc)
  • Drug Product Manufacturing a big PLUS
  • Exp with R and/or Python


Summary:

The role would be to support modeling activities in the Manufacturing Science and Technology department within Client Innovative Medicine. The role will involve utilizing process modeling and data science to support various advanced therapies manufacturing processes. In addition, the position would likely include investigational support for identifying process optimizations and/or root cause analysis. Finally, the role may also involve developing characterization models for specific stages of the manufacturing process. We are seeking someone who thrives in a collaborative environment, possesses a strong analytical mindset, and demonstrates exceptional problem-solving skills. In this role, you will have the unique opportunity to work alongside a team of innovative professionals who are committed to making a positive impact in the field of advanced therapies manufacturing. The candidate will be responsible for design, planning, development and monitoring of clinical evaluation projects. They will interpret research results and evaluates the safety, marketability and medical usefulness of drug and product candidates.


Responsibilities:

  • Develop and deploy real-time multivariate monitoring models using statistical software to support the technology transfer and manufacturing of advanced therapies processes
  • Identify, develop and implement process improvement initiatives
  • Apply creative solutions to various data science projects
  • Provide technical support to process investigations
  • Create predictive models to help achieve optimal process performance
  • Monitors clinical evaluation projects, experimental protocols and patient forms.
  • Performs duties including protocol development, the maintenance of investigational sites, development of case report forms, informed consent, study drug projections and communication.
  • Documents and reviews steps needed for data collection, analysis.
  • Maintains correct standard operations, procedures and protocol.
  • Participates in interpretation results for phase 14 investigations in preparing for new drug application to the appropriate governmental body.
  • Adheres to clinical research guidelines and safety procedures.
  • Acquires knowledge and full understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies.
  • Participates in verifying essential conditions that are necessary to determine the safety, efficacy, medical usefulness, and marketability of drug and product candidates. Communicates detailed outcomes and results of research findings to customer and management.
  • Provides input to project planning and implementation activities.
  • Prepares relevant registrations, submissions and reports.
  • Serves as liaison to clinical sites and other vendors, as well as internal/external customers.
  • Prepares research status and findings reports for internal/external meetings, including investigator meetings and company sponsored events


Qualifications:

  • MS / BS in an engineering discipline (biomedical, chemical, biochemical, biostatistics etc.), or any life science equivalent in computational sciences
  • Requires a minimum of 2+ years of work experience
  • Knowledge and experience in data analyses, visualization and report writing is required
  • Experience using either R or python; and git version control; and/or other statistical software
  • Knowledge of statistics and analyses (e.g. ANOVA, T-tests, Regression, Control Charts)

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