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Job Requirements of Associate Scientist:
-
Employment Type:
Contractor
-
Location:
Summit, NJ (Onsite)
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Associate Scientist
Careers Integrated Resources Inc
Summit, NJ (Onsite)
Contractor
Job Title: Associate Scientist
Location: Summit, NJ 07901
Duration: 6+ Months with possible extension
Work Schedule: Nights 7 PM – 7 AM; every other weekend rotation
Pay Rate: $47.55/hr. on W2
Job Description:
Purpose and Product of Position:
Required Competencies:
Knowledge, Skills, and Abilities:
Education and Experience:
Duties and Responsibilities:
Working Conditions (US Only):
Compensation Details:
Location: Summit, NJ 07901
Duration: 6+ Months with possible extension
Work Schedule: Nights 7 PM – 7 AM; every other weekend rotation
Pay Rate: $47.55/hr. on W2
Job Description:
- 100% onsite.
- Work Schedule: Mon-Fri (normal business hours).
Purpose and Product of Position:
- The Associate Scientist/Engineer is responsible for leading investigation reports in support of S12 CAR T operations.
- This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems.
- The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.
Required Competencies:
Knowledge, Skills, and Abilities:
- Working experience of deviation investigations utilizing root cause analysis tools.
- Working experience in the CAPA process and ability to identify and verify effectiveness.
- Technical writing skills and ability to collaborate effectively in cross functional teams.
- Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
- Ability to support health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software a plus.
- Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
- Ability to set priorities, manage timelines and effectively react/manage changing priorities.
- Ability to work with management (global and site) and support corporate and departmental goals.
- Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
- Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity.
- Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
Education and Experience:
- Minimum Associate degree required or preferred a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline.
- Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
- Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).
- An equivalent combination of education and experience may substitute.
Duties and Responsibilities:
- Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
- Lead investigations and cross functional investigation teams, and close reports in a timely manner.
- Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
- Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
- Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
- May Initiate change control documentation.
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support deviation investigation defense during audits and site inspections related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
- Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset.
Working Conditions (US Only):
- The incumbent will be working 80% to 90% of the time in an office environment.
- The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
- The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
- The incumbent will need to have flexibility to work extended hours (> 8 hours/day), weekend and/or holidays when required to meet deadlines.
Compensation Details:
- The starting hourly compensation for this assignment is within the range of $37.44 - 47.55/hr.
- Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not Client).
- Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job.
- Compensation details are subject to change.
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