Novartis Farmacéutica
Senior Expert Stability
Novartis Farmacéutica, East Hanover, New Jersey, us, 07936
The Senior Expert, Stability manages the planning, sampling, execution and data management of cell and gene therapy clinical program stability studies.About the Role
Key Responsibilities:Participates in Stability strategy and protocol design for cell and gene therapy clinical products.Oversight and coordination with internal partners or Contract Development & Manufacturing Organization (CDMO)/Contract Manufacturing Organization (CMO) for stability program management.Writes technical reports; technical report generation (Expiry, Result Record, Investigations).Data management to support the Stability Programs including the administration and distribution of Quality Control (QC) stability samples, associated document coordination, and collection and evaluation of data.Owner of stability work processes supporting the stability programs.Participates in study design and ensures scheduling of stability lots.Tracks stability time points and evaluates stability data on a routine basis.Document owner for procedures and work instructions in support of stability processes.Owner and assessor of out of trend (OOT) and out of specification (OOS) events.Owner, assessor, and/or reviewer of deviations, change controls, and lab investigations and may generate metrics for stability programs. May also report risks related to stability programs to Quality System Owner(s).Minimum Requirements:Bachelors' and/or Masters' Degree in scientific discipline with a technical understanding of biopharmaceutical or Gene therapy production (gene and/or cell therapy development and manufacturing experience advantageous).Minimum of 5 years of Good Manufacturing Practice QC/QA lab experience. Experience in Stability is highly preferred.Knowledge of Biologics and/or Gene therapy testing methods, validation and qualification.Knowledge of ICH, specifically stability guidelines.Excellent oral and written communication skills with technical writing experience, with expertise in use of MS suite of programs (Outlook, Excel, PowerPoint, Word, etc.).Ability to work independently, collaboratively, and effectively. Problem-solving aptitude with ability to prioritize and deliver on tight timelines.Understanding of Lab Information Management Systems (LIMS), database query, and data generation flow to reporting and visualization is beneficial.Experienced quality professional with knowledge of the drug development and quality control process and associated methods.The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#J-18808-Ljbffr
Key Responsibilities:Participates in Stability strategy and protocol design for cell and gene therapy clinical products.Oversight and coordination with internal partners or Contract Development & Manufacturing Organization (CDMO)/Contract Manufacturing Organization (CMO) for stability program management.Writes technical reports; technical report generation (Expiry, Result Record, Investigations).Data management to support the Stability Programs including the administration and distribution of Quality Control (QC) stability samples, associated document coordination, and collection and evaluation of data.Owner of stability work processes supporting the stability programs.Participates in study design and ensures scheduling of stability lots.Tracks stability time points and evaluates stability data on a routine basis.Document owner for procedures and work instructions in support of stability processes.Owner and assessor of out of trend (OOT) and out of specification (OOS) events.Owner, assessor, and/or reviewer of deviations, change controls, and lab investigations and may generate metrics for stability programs. May also report risks related to stability programs to Quality System Owner(s).Minimum Requirements:Bachelors' and/or Masters' Degree in scientific discipline with a technical understanding of biopharmaceutical or Gene therapy production (gene and/or cell therapy development and manufacturing experience advantageous).Minimum of 5 years of Good Manufacturing Practice QC/QA lab experience. Experience in Stability is highly preferred.Knowledge of Biologics and/or Gene therapy testing methods, validation and qualification.Knowledge of ICH, specifically stability guidelines.Excellent oral and written communication skills with technical writing experience, with expertise in use of MS suite of programs (Outlook, Excel, PowerPoint, Word, etc.).Ability to work independently, collaboratively, and effectively. Problem-solving aptitude with ability to prioritize and deliver on tight timelines.Understanding of Lab Information Management Systems (LIMS), database query, and data generation flow to reporting and visualization is beneficial.Experienced quality professional with knowledge of the drug development and quality control process and associated methods.The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#J-18808-Ljbffr