Biotechnology Specialist

4 weeks ago

Princeton, New Jersey, United States Experis Full time
Job Title: Investigator, MS&T (Manufacturing Science and Technology)

We are seeking a highly skilled Investigator, MS&T (Manufacturing Science and Technology) to join our team at Experis. As a key member of our organization, you will be responsible for providing technical support and expertise in gene/cell therapy manufacturing processes.

Key Responsibilities:
  • Provide technical support to the Princeton, NJ facility, including troubleshooting process and equipment-related issues.
  • Work closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identify root cause, and implement long-term preventive actions.
  • Participate in process tech transfer and incoming process changes, communicate changes to applicable departments, and lead process improvement projects at the site.
  • Identify and drive continuous improvements to the manufacturing process, function as a technology and process subject matter expert, and provide on-the-floor and on-site technical support when necessary.
  • Author, review, and approve various documents, including batch records, SOPs, and protocol and reports in accordance with internal and external regulatory expectations.
  • Analyze and summarize manufacturing data to support impact assessments and investigations, and lead technology transfer efforts for new processes and product implementation.
  • Perform tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs, and apply continuous improvement tools to identify and close procedural and compliance gaps.
  • Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts, representing MSAT and interfacing with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
Requirements:
  • BSc and/or Advanced degree in Science or Chem/Bio Engineering.
  • Minimum 5 years of industry experience.
  • Minimum 3 years relevant experience in GMP biologic/cell therapy manufacturing technical or process support.
  • Advanced degree(s) preferred.
  • Scientific understanding in bioprocessing principles, familiarity with cell therapy processes and cGMP, and experience in Process qualification, validation.
  • Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities, and experience working with external parties and/or cross-functional teams.
  • Possess strong verbal/written communication skills and ability to influence at all levels, ability to think strategically, and ability to prioritize tasks in a highly dynamic environment.

We look forward to speaking with you about this exciting opportunity to join our team at Experis.

  • Laboratory Equipment Calibration Specialist

    2 weeks ago

    Princeton, New Jersey, United States Joulé Full time

    Job Title: Laboratory Equipment Calibration Specialist - Biopharma/Consumer HealthAt Joule, a System One division, we are seeking a skilled Laboratory Equipment Calibration Specialist to join our dynamic internal team. As a leading provider of analytical equipment support, consulting, and integrated services to top pharmaceutical and biotechnology companies...

  • Regulatory Operations Specialist

    2 weeks ago

    Princeton, New Jersey, United States Joulé Full time

    Job Title: RA/QA Operations Specialist We are seeking a highly organized and detail-oriented RA/QA Operations Specialist to join our team at Joule. This is a full-time, hybrid position in Princeton, NJ. Responsibilities: Conduct regulatory document filing and processing Perform administrative functions for the RA/QA department, including expense...

  • Regulatory Affairs Specialist

    2 weeks ago

    Princeton, New Jersey, United States System One Full time

    Job Title: RA/QA Operations SpecialistWe are seeking a highly organized and detail-oriented RA/QA Operations Specialist to join our team at System One. As a key member of our regulatory operations team, you will be responsible for conducting regulatory documents or submissions, filing or processing, cleaning and managing folders or files, and SOP Committee...

  • Laboratory Equipment Calibration Specialist

    4 days ago

    Princeton, New Jersey, United States System One Full time

    Job Title: Laboratory Equipment Calibration Specialist – BioPharma/Consumer HealthLocation: Princeton, NJHours/Schedule: M-F 8AM-5PMType: Direct HireAbout Us:Joule, a System One division, is seeking a skilled Calibration Specialist to join our dynamic team. We provide analytical equipment support, consulting, and integrated services to leading...

  • Regulatory Operations Specialist

    1 month ago

    Princeton, New Jersey, United States System One Full time

    Job Title: RA/QA Operations SpecialistWe are seeking a highly organized and detail-oriented RA/QA Operations Specialist to join our team at System One. As a key member of our regulatory operations team, you will be responsible for conducting regulatory documents or submissions, filing or processing, cleaning and managing folders or files, and SOP Committee...

  • Talent Acquisition Specialist

    3 days ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job OverviewLynkx Staffing LLC is seeking a highly skilled Talent Acquisition Manager to join our team. As a key member of our recruitment team, you will be responsible for identifying and attracting top talent in the pharmaceutical industry.Develop and implement innovative sourcing strategies to build pipelines for current and future hiring demands.Partner...

  • Computer System Validation Specialist

    1 week ago

    Princeton, New Jersey, United States TK-CHAIN LLC Full time

    Job DescriptionAt TK-CHAIN LLC, we are seeking a highly skilled Computer System Validation Specialist to lead the design, development, and execution of test scripts and test plans to identify software problems and their causes.The ideal candidate will have experience in coordinating and executing performance and functional testing associated with multiple...

  • Sales Analytics Specialist

    1 week ago

    Princeton, New Jersey, United States Moderna Full time

    About the RoleModerna is seeking a highly analytical and detail-oriented Sales Analytics Specialist to join our dynamic Sales Operations team. As a key member of our commercial organization, you will be responsible for proactively analyzing sales data, identifying trends, and providing actionable insights that contribute to the company's strategic goals and...

  • Sales Analytics Specialist

    2 weeks ago

    Princeton, New Jersey, United States Moderna Full time

    About the RoleModerna is seeking a highly analytical and detail-oriented Sales Analytics Specialist to join our dynamic Sales Operations team. As a key member of our commercial organization, you will be responsible for proactively analyzing sales data, identifying trends, and providing actionable insights that contribute to the company's strategic goals and...

  • Laboratory Equipment Calibration Specialist

    2 weeks ago

    Princeton, New Jersey, United States System One Holdings, LLC Full time

    Job Title: Laboratory Equipment Calibration TechnicianLocation: Princeton, NJHours/Schedule: M-F 8AM-5PMType: Direct HireAbout UsJoule, a System One division, is a leading provider of analytical equipment support, consulting, and integrated services to pharmaceutical and biotechnology companies across the U.S.With over $1.3 billion in sales last year and 51...

  • Laboratory Equipment Calibration Specialist

    4 weeks ago

    Princeton, New Jersey, United States System One Full time

    Job Title:Laboratory Equipment Calibration Technician – BioPharma/Consumer HealthLocation:Princeton, NJHours/Schedule:M-F 8AM-5PMType:Direct HireAbout Us:Joule, a System One division, is seeking a dynamic individual to join our internal team. We specialize in providing analytical equipment support, consulting, and integrated services to leading...

  • Laboratory Equipment Calibration Specialist

    2 weeks ago

    Princeton, New Jersey, United States System One Full time

    Job Title:Laboratory Equipment Calibration Technicians – BioPharma/Consumer HealthLocation: Princeton, NJHours/Schedule: M-F 8AM-5PMType: Direct HireAbout Us: Joule, a System One division, is seeking a dynamic individual to join our internal team. We specialize in providing analytical equipment support, consulting, and integrated services to leading...

  • Director, Field Operations and Insights

    4 weeks ago

    Princeton, New Jersey, United States Moderna Full time

    About the RoleModerna is seeking a highly analytical and detail-oriented sales analytics specialist to join our dynamic Sales Operations team. As a key member of our commercial organization, you will be responsible for proactively analyzing sales data, identifying trends, and providing actionable insights that contribute to the company's strategic goals and...