Our client, a leading pharmaceutical company, is hiring a Sr. Scientist Engineer Investigation on a contract basis.
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.
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 Bachelors 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.