Senior Scientist in Summit, NJ
- Title: Senior Scientist
- Code: RCI-52036-1
- RequirementID: 105327
- Location: Summit, NJ 07901
- Posted Date: 01/25/2023
- Duration: 6 Months
- Salary ($): 64.44 - 68.55 per Hourly
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
- 100 % onsite position
- Duration: 6 months(high possibility of extension or conversion, depending on performance for the right candidate).
- Minimum Bachelor's degree required, Master's degree preferred in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline
Purpose And Scope of Position:
- The Senior Scientist is responsible for supporting compliance related activities within the S12 Quality Control department in direct support of clinical and commercial CAR T manufacturing operations.
- This includes the ability to interface with cross functional groups, independently perform tasks, interpret results, author protocols/reports, conduct thorough root cause investigations (including experiment design and hypothesis testing), identify robust corrective and preventive actions (CAPA) and troubleshoot complex problems.
- Additionally, the Senior Scientist will be responsible for continuous improvements, and ownership of change management records within the QC department.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Advanced working experience of deviation investigations utilizing root cause analysis tools.
- Working experience in the CAPA process and ability to identify and verify effectiveness.
- Working experience in the change management and associated change control processes.
- Advanced 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.
- Experience supporting health authority inspections.
- Knowledge of data trending and tracking, including use of statistical analysis software.
- 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).
- Hands on experience preferred with various analytical techniques such as ELISA, qPCR, Cell Concentration, Sterility, Mycoplasma, Endotoxin, flow cytometry, and Environmental Monitoring.
- Hands on experience preferred with Manufacturing Environmental Monitoring programs, which includes viable and non-viable air particulates, surface sampling and personnel monitoring.
- Knowledge of Manufacturing class designation, such as Class D, Class C and Class A.
- Strong understanding of Contamination Control, such as air flow, movement of materials and personnel.
- Ability to mentor junior associates to foster and develop their expertise.
Education and Experience:
- Requires a Bachelor’s Degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline (advanced degree preferred).
- 5+ years of relevant work experience, preferably in a health authority regulated environment.
- Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).
- An equivalent combination of education and experience may substitute.
Duties And Responsibilities:
- Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
- Perform GEMBA walks with stakeholders to better understand process steps, and evaluate the need to make process improvements, with the coordination of Subject Matter Experts.
- Identify 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.
- Initiate change control documentation and assist other QC functional groups with change management documentation.
- Identify functional area SMEs to perform impact assessments as part of the change management process.
- Ensure all investigations, CAPAs and change controls 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 QC during audits and site inspections for QC compliance related inquiries.
- Handle complex issues and solve problems with minimal guidance.
- Provide mentorship, guidance and training to junior members.
- Serve as author or technical reviewer of departmental procedures as appropriate.
- Support manufacturing and Quality Control testing of CAR-T products as needed.
- Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
- Continuously support QC, 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.
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