Lenti Investigator
About The Position
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. We are searching for the best talent for a Lenti Investigator to join our team in Raritan, NJ. Summary: The Investigator will lead cross-functional investigations teams to identify true root cause of investigations, conduct risk assessments, and assess the impact of nonconformances.
Requirements
- A minimum of a Bachelor's degree is required, focus degree in Engineering and/or Life Science is preferred.
- Minimum 2 years of relevant work experience
- Ability to read, analyze, and interpret technical documents,SOPs, common scientific / technical journals, legal documents, and government regulations/guidance documents (EU GMPs, Annex 1, CFR, USP)
- Excellent written and oral communication skills
- Experience within cell/gene therapy, biopharmaceutical, or pharmaceutical industry
Nice To Haves
- Experience with one or more of the following enterprise systems: eLIMS, Salesforce, Maximo, EMS, TrackWise, Veeva, and/or SAP
- Experience with internal and/or external regulatory audits/inspections
- Experience with quality investigations, including root-cause analysis of nonconformance events and familiarity with root cause analysis tools
Responsibilities
- Conduct root cause analysis investigations and author nonconformance reports.
- Coordinate discussion to identify process improvements related to safety, environmental, quality, compliance, efficiency, and yield.
- Recognize and act on potential compliance issues and opportunities for process changes/improvement.
- Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
- Coordinate data collection and trend analysis in support of nonconformance management and/or audit activities
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
