- Bristol Myers Squibb (Devens, MA)
- …retain technical people leaders and build high performing teams. + Strong knowledge of GxP , particularly as relates to IT (21 CFR Part 11, Data Integrity, etc.) and ... experience working in a Pharmaceutical GMP environment. + Experience with application of Syncade MES, DeltaV, Aveeva Pi, SAP, LIMS/ELN and finite scheduling in biologics manufacturing. Working knowledge of S88 and S95 standards. + Knowledge of Client-server… more
- Actalent (Boston, MA)
- …cell therapy experience in an early-phase organization. + Strong understanding of GxP Quality and expertise in Quality Management System development and execution. + ... Experience managing Quality Systems for external manufacturing. + Knowledge of Biologics manufacturing sciences and processes at clinical and commercial stages. + Experience engaging with global health authorities. + Ability to work in a fast-paced… more
- Sanofi Group (Waltham, MA)
- …and External Audit schedules/programs. + Promote a quality mindset within the GxP operational areas by ensuring consistent, risk based and innovative thought ... processes are employed to advise and make decisions. + Ensure implementation and evaluation of corrective and preventative actions to address systemic issues. + Motivate and coach the Quality Operations team to operational success- both in terms of quality… more
- Sanofi Group (Cambridge, MA)
- …Maintain accurate and compliant records of experiments in a Good Practice ( GxP ) compliant electronic notebook system. **About you** **Experience** : + Experience ... working in a regulated environment Good Clinical Laboratory Practice (GCLP) in support of nonclinical and clinical development projects. **Soft and Technical skills:** + Proficient written and oral communication skills along. + Ability to work collaboratively… more
- TEKsystems (Boston, MA)
- …needs into scalable digital solutions + Maintain app versioning, permissions, and compliance with GxP and 21 CFR Part 11 standards + Resolve issues related to app ... logic, performance, and data flow + Produce technical documentation, process maps, and integration protocols Qualifications + Bachelor's degree in Engineering, Computer Science, or related field + Experience in MES development, preferably with Tulip + Strong… more
- Cytel (Cambridge, MA)
- …or functional requirements. + Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Here at Cytel we want our employees to succeed and we ... enable this success through consistent training, development and support. To be successful in this position you will have: + Bachelor's degree in Life Sciences, Health Informatics, or related field + 10+ years of progressive experience in clinical data… more
- ThermoFisher Scientific (Boston, MA)
- …setting is preferred. Experience working in customer service preferred. + GxP Experience and IATA/DOT certification, knowledge of OSHA General Industry requirements ... are also a plus. **Knowledge, Skills, Abilities** + Strong verbal and written communication skills, and desire to deliver excellent customer service. This includes maintaining a professional appearance and demeanor in all interactions and upholding Thermo… more
- Sanofi Group (Cambridge, MA)
- …plus. **Technical skills** : + Proven expertise in pharmaceutical manufacturing, GxP documentation and related Equipment Qualification and Process Validation of high ... throughput equipment. + Strong technical skills and familiarity with competitive landscape, industry trends, and regulatory environment. + Strong analytical, problem solving, and technical writing skills, + Working competency of statistical programs (eg… more
- AbbVie (Worcester, MA)
- …appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable. Qualifications Qualifications + ... Bachelors degree in Biochemistry, Bioengineering, or Pharmaceutical Sciences with 5 years of relevant experience or Master's Degree in Biochemistry, Bioengineering, or Pharmaceutical Sciences or equivalent education with typically two years of experience. +… more
- ThermoFisher Scientific (Cambridge, MA)
- …managed services in a laboratory setting. Experience working in Good x Practice ( GxP ) environment and The International Air Transport Association (IATA) and the US ... Department of Transportation (DOT) Hazardous Goods certification required, knowledge of OSHA General Industry requirements are also a plus. Experience with handling large volumes of inventory and customer service. **Knowledge, Skills, Abilities** + Leadership… more