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.
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.
Required Skills:
Requires a Bachelor's Degree in science, preferably in Biochemistry, Immunology, Molecular and Cellular Biology, Biology, Microbiology or related discipline (advanced degree preferred).
Minimum Bachelor's degree required, Master's degree preferred in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline .
5+ years of relevant work experience, preferably in a health authority regulated environment.
An equivalent combination of education and experience may substitute.
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.
E xperience supporting health authority inspections.
Knowledge of data trending and tracking, including use of statistical analysis software.
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.
Previous experience in a gene or cell therapy facility is preferred (CAR-T a plus).
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.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00209
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
