Associate Scientist- CAR T Manufacturing Investigations (Onsite, Summit, NJ)
We are looking for an Associate Scientist for a Global pharmaceutical Company. The focus of this role is to lead investigation reports in support of S12 CAR T operations that include the 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.
This is a 40-hour per-week (4 pm- 2 am EST), 6-month contract (extensions possible), 100% onsite role in Summit, NJ (The candidate must be able to work onsite 5 days a week).
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities
- Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
- 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.
- Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
- Support deviation investigation defense during audits and site inspections related inquiries.
- 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.
Requirements
- Experience in deviation investigations utilizing root cause analysis tools.
- 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, and apply Global Regulatory and cGMP requirements.
- Ability to support health authority inspections. Knowledge of data trending and tracking, including the use of statistical analysis software a plus.
- Experience in utilizing electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity
- Experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.
- 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.
Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Associate Scientist- CAR T Manufacturing Investigations (Onsite, Summit, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $45/hr to $48.94/hr