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Controller Biotech

Winston Salem,NC

339 Controller Biotech jobs in Winston Salem,NC

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FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

Thermo Fisher Scientific

Winston-Salem, NC

Onsite

  • At least Bachelors' degree (or country equivalent) in computer science, data science, computational linguistics, applied statistics/biostatistics, life sciences / Information technology or other relevant field required.
  • Python, ML/NLP frameworks, model deployment/monitoring, MLOps tooling, ideally exposure to LLMs on unstructured clinical/safety text.
  • Working understanding of safety database data models (Argus/ArisG) and E2B(R3) structure.
  • Relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management
  • Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills
  • Proficiency in Python for ML development, including scikit-learn, pandas, NumPy; experience with at least one deep learning framework (PyTorch or TensorFlow).
  • Natural language processing for extraction of adverse events, drugs, and outcomes from unstructured text - case narratives, medical literature, call transcripts, and spontaneous reports.
  • Named Entity Recognition (NER), relation extraction, and text classification
  • Experience with transformer-based / large language models (BERT-family, clinical/biomedical models such as BioBERT or PubMedBERT, and modern LLMs) for narrative generation, summarization, and information extraction.
  • MedDRA and WHODrug auto-coding using ML/NLP; prompt engineering and retrieval-augmented generation (RAG) a plus.
  • Supervised and unsupervised methods for classification, clustering, and anomaly detection.
  • Feature engineering and model evaluation (precision/recall trade-offs, ROC/AUC, calibration) with an understanding of why recall and sensitivity are weighted heavily in a safety context.
  • Model lifecycle management: versioning, monitoring, drift detection, retraining pipelines using standard MLOps tooling (e.g. MLflow, Azure ML, Databricks) in line with client DT/BIS standards
  • Model explainability / interpretability (SHAP, LIME) - essential where decisions must be defensible to health authorities.
  • Understanding of GxP / GAMP 5 validation as applied to AI/ML systems, model governance, and emerging regulatory expectations (EMA reflection paper on AI, FDA guidance) — rare and worth flagging as preferred.
  • Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems) is a plus.
  • Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards
  • Solid understanding of the quality management processes, metrics and KPIs
  • Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
  • Proficient in the Microsoft 365 stack (Excel, Word, PowerPoint, Teams, SharePoint, OneDrive) and in modern collaboration and documentation tooling
  • Advanced Excel required; working proficiency in SQL required for querying safety and operational datasets
  • Fluent communication in written and spoken English required
  • Ability to work independently with minimal oversight and prioritize effectively
  • Ability to complete multiple complex deliverables within tight timelines
  • Ability to function effectively in a team environment
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New, Posted 21 hours ago
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Preventative Maintenance Technician

Smurfit Westrock

Winston Salem, NC 27101

OnsiteHealth InsuranceRetirement Benefit

  • High school diploma or equivalent
  • Proven experience in maintenance, repair, and troubleshooting of industrial equipment
  • Solid understanding of relay logic, PLCs, and pneumatic systems
  • Familiarity with NFPA 70E standards and ability to apply them in the workplace
  • Candidates are required to undergo a drug screening after receiving a conditional job offer, but before starting employment.
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Traffic Control Technician II

RoadSafe Traffic Systems, Inc.

High Point, NC 27263

New, Posted 21 hours ago
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Radiology Technologist Extender

Cone Health

Greensboro, NC 27403

~ 36 min Onsite

  • Required: High School Diploma or equivalent.
  • Required: BLS (CPR)-American Red Cross or AHA Healthcare Provider.
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Information Systems Technician

US Navy

Winston Salem, NC 27107

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Information Systems Technician

US Navy

Kernersville, NC 27284

New, Posted 10 hours ago
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Medical Director/Clinical Trial Physician(Rheumatology) - FSP

Thermo Fisher Scientific

Winston-Salem, NC

Remote

  • Medical Doctor or equivalent degree required
  • Board certification(s) are preferred
  • Specialty education(e.g. residency/fellowship) required in rheumatology. This should be accompanied by patient treatment and/or research experience
  • 1-3 years of industry experience preferred. Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization
  • Excellent English, both written and spoken is a must
  • Ability to travel
  • Must be legally authorized to work in the United States without sponsorship
  • Must be able to pass a comprehensive background check, which includes a drug screening
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Sr Manufacturing Engineer

General Dynamics Mission Systems

Greensboro, NC 27406

$94,562/yr
~ 36 min OnsiteFlexible Schedule

  • Bachelor's degree in Manufacturing or Industrial Engineering, or a related Science, Engineering or Mathematics field, plus a minimum of 2 years of relevant experience; or Master's degree, plus 6 months relevant experience.
  • U.S. citizenship is required.
  • Department of Defense Secret security clearance is preferred at time of hire.
  • Applicants selected will be subject to a U.S. Government security investigation and must meet eligibility requirements for access to classified information.
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New, Posted 21 hours ago
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Radiology Tech Extender

Cone Health

Greensboro, NC 27401

~ 36 min Onsite

  • Required: High School Diploma or equivalent.
  • Required: BLS (CPR)-American Red Cross or AHA Healthcare Provider.
SmartExplore AI is experimental.
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iHire
Automotive Technician

BOB KING AUTOMOTIVE GROUP

Winston Salem, NC 27101

$72.50/hr
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