Research Scientist

1 week ago

Akron, Ohio, United States Cynet Systems Full time
Job Overview

We are seeking a Research Scientist for our client.

Position Title: Research Scientist

Location: Summit, NJ

Employment Type: Contract

Compensation: $46/hr - $49/hr

Key Responsibilities:

  • Conduct comprehensive investigations including Environmental Monitoring and deviations, utilizing root cause analysis methodologies.
  • Lead investigations and cross-functional teams, ensuring timely closure of reports.
  • Perform GEMBA walks with stakeholders to gain insights into process steps and evaluate root causes.
  • Collaborate with functional teams to propose effective Corrective and Preventive Actions (CAPAs), develop CAPA plans, and ensure their effectiveness.
  • Evaluate potential impacts and risks associated with changes to products or processes and devise appropriate mitigation strategies.
  • Initiate change control documentation as necessary.
  • Identify subject matter experts in functional areas to conduct impact assessments during the change management process.
  • Ensure all investigations are completed promptly and communicate any delays to stakeholders.
  • Provide technical support for manufacturing investigations, CAPAs, and change controls as required.
  • Assist in defending deviation investigations during audits and site inspections.
  • Address complex issues and resolve problems with minimal supervision.
  • Serve as an author or technical reviewer for departmental procedures as needed.
  • Apply lean manufacturing and Six Sigma principles to enhance products, processes, and systems continuously.

Qualifications:

  • Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences, or a related engineering discipline (advanced degree preferred).
  • At least 1 year of relevant experience, ideally in a regulated health authority environment.
  • Experience in a biopharmaceutical manufacturing facility is preferred.
  • An equivalent combination of education and experience may be considered.

Skills and Competencies:

  • Experience with deviation investigations and root cause analysis tools.
  • Familiarity with the CAPA process and the ability to assess and verify effectiveness.
  • Strong technical writing skills and the ability to collaborate effectively within cross-functional teams.
  • Proven understanding of Global Regulatory and cGMP requirements.
  • Ability to support health authority inspections.
  • Knowledge of data trending and statistical analysis software is a plus.
  • Demonstrated advanced problem-solving skills and logical thinking.
  • Ability to prioritize tasks, manage timelines, and adapt to changing priorities.
  • Effective communication skills with peers and management.
  • Experience with electronic Quality systems such as eQRMs or Infinity is preferred.
  • Hands-on experience in CAR-T or biopharmaceutical manufacturing and Quality Control is advantageous.
Company Overview

Visit our career site to explore all open positions.

  • Scientist

    2 months ago

    Akron, Ohio, United States Bristol Myers Squibb Company Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Division Director of Psychology and Behavioral Health Research

    1 week ago

    Akron, Ohio, United States Akron Children's - Physician Recruitment Full time

    Division Director of Psychology and Behavioral Health ResearchAkron Children's Hospital is committed to building a diverse workforce that reflects the communities we serve.We are seeking a highly qualified candidate to serve as the Division Director of Psychology and the Director of Behavioral Health Research. This is a unique opportunity to join a...

  • Director of Pediatric Psychology and Behavioral Health Research

    11 hours ago

    Akron, Ohio, United States Akron Children's Hospital Full time

    Job SummaryWe are seeking a highly qualified individual to serve as the Director of Pediatric Psychology and Behavioral Health Research at Akron Children's Hospital. This is a unique opportunity to lead both the Division of Psychology and the Behavioral Health Research program, with a dual appointment at the Northeast Ohio Medical University.Division...

  • Scientist, Chemical Process Development

    2 months ago

    Akron, Ohio, United States Bristol Myers Squibb Company Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Senior Research Investigator, Clinical Pharmacology and Pharmacometrics

    4 weeks ago

    Akron, Ohio, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Associate Scientist, Biologics Process Analytics

    1 month ago

    Akron, Ohio, United States Bristol Myers Squibb Company Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Technical Service Leader for Specialty Adhesives

    1 day ago

    Akron, Ohio, United States Synthomer Full time

    Job SummaryWe are seeking a highly skilled and experienced Technical Service Leader to join our Adhesive Solutions team at Synthomer. As a Principal Application Scientist, you will play a key role in supporting our specialty customers and distributors, working closely with sales and account managers to develop and execute business strategies.Key...

  • Director of Pediatric Psychology and Behavioral Health Research

    3 months ago

    Akron, United States Akron Children's Hospital Full time

                            Director of Psychology and Behavioral Health ResearchWe are offering a dual position for a candidate that will serve both  as the Division Director of Psychology and the Director of Behavioral Health Research at Akron Children's.  An academic appointment is availableat the Northeast Ohio Medical University.The Division...