Novartis
Associate Expert Science & Technology, Stability & Microbiology
Novartis, East Hanover, New Jersey, us, 07936
Overview
Associate Expert Science & Technology, Stability & Microbiology – East Hanover, NJ (On-site). This role is based in East Hanover, New Jersey. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you. At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation. Under general direction, this role will perform stability and EM testing and other activities in functions supporting the Quality Control department. Responsibilities
Support stability program for Cell and gene therapy including protocol, report authoring and stability sample management and testing. Perform EM testing in support of clinical release strategies, performing all testing and activities compliantly following SOPs and procedures. Support raw material inspection and sample management, execute and follow SOPs, WPs, and quality policies. Peer review and archive analytical data in lab documentation systems and support monthly/quarterly laboratory cleaning. Maintain laboratory logbooks, ensure cleanliness of laboratory working areas, and perform monthly laboratory cleaning. Manage reagent/consumable inventory and equipment cleaning for assigned areas; support and author OOS/OOE/OOT and deviation investigations. Participate in CAPA implementation in a timely manner; follow GxP quality policies and procedures; support 5S and Lean projects. Identify process improvements and interface with regulatory agencies during audits as required. Knowledge of LabWare, LIMS and/or other QC data systems; knowledge of GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.). Collect and generate data for stability trend reporting. Contribute to the gowning qualification program by taking samples and analyzing/generating data. Provide coverage for all appropriate areas in addition to primary duties. Contribute to assigned projects by following predefined tasks and executing as instructed. Perform other job duties as assigned. Qualifications
Essential: A BA/BS degree in microbiology, biology, biochemistry, or related science. Master’s degree preferred. Essential: A minimum of 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related field. Essential: Knowledge of cGMP and understanding of GDP, good clinical practices and FDA guidelines, applicable regulations, and industry standards (e.g., ANSI, ISO). Essential: Knowledge of stability program and sample management. Essential: Environmental Monitoring knowledge to facilitate investigations. Essential: Clear communication with a variety of individuals in Novartis operations. Essential: Detail-oriented with strong problem-solving and decision-making abilities. Essential: Strong interpersonal skills and professional demeanor. Essential: Strong written and verbal communication skills. Desirable: Knowledge of LIMS systems. Salary, Benefits & Employment Type
The salary for this position is expected to range between $55,000 and $102,200 per year. The final salary offered is based on factors like relevant skills and experience and will be reviewed periodically. Novartis may adjust the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and, depending on the role level, eligibility for annual equity awards. US-based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time-off package including vacation, personal days, holidays and other leaves. EEO & Accessibility
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for the application process or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and include the job requisition number in your message. Seniority level
Entry level Employment type
Full-time Job function
Information Technology Industries
Pharmaceutical Manufacturing
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Associate Expert Science & Technology, Stability & Microbiology – East Hanover, NJ (On-site). This role is based in East Hanover, New Jersey. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you. At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation. Under general direction, this role will perform stability and EM testing and other activities in functions supporting the Quality Control department. Responsibilities
Support stability program for Cell and gene therapy including protocol, report authoring and stability sample management and testing. Perform EM testing in support of clinical release strategies, performing all testing and activities compliantly following SOPs and procedures. Support raw material inspection and sample management, execute and follow SOPs, WPs, and quality policies. Peer review and archive analytical data in lab documentation systems and support monthly/quarterly laboratory cleaning. Maintain laboratory logbooks, ensure cleanliness of laboratory working areas, and perform monthly laboratory cleaning. Manage reagent/consumable inventory and equipment cleaning for assigned areas; support and author OOS/OOE/OOT and deviation investigations. Participate in CAPA implementation in a timely manner; follow GxP quality policies and procedures; support 5S and Lean projects. Identify process improvements and interface with regulatory agencies during audits as required. Knowledge of LabWare, LIMS and/or other QC data systems; knowledge of GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.). Collect and generate data for stability trend reporting. Contribute to the gowning qualification program by taking samples and analyzing/generating data. Provide coverage for all appropriate areas in addition to primary duties. Contribute to assigned projects by following predefined tasks and executing as instructed. Perform other job duties as assigned. Qualifications
Essential: A BA/BS degree in microbiology, biology, biochemistry, or related science. Master’s degree preferred. Essential: A minimum of 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related field. Essential: Knowledge of cGMP and understanding of GDP, good clinical practices and FDA guidelines, applicable regulations, and industry standards (e.g., ANSI, ISO). Essential: Knowledge of stability program and sample management. Essential: Environmental Monitoring knowledge to facilitate investigations. Essential: Clear communication with a variety of individuals in Novartis operations. Essential: Detail-oriented with strong problem-solving and decision-making abilities. Essential: Strong interpersonal skills and professional demeanor. Essential: Strong written and verbal communication skills. Desirable: Knowledge of LIMS systems. Salary, Benefits & Employment Type
The salary for this position is expected to range between $55,000 and $102,200 per year. The final salary offered is based on factors like relevant skills and experience and will be reviewed periodically. Novartis may adjust the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and, depending on the role level, eligibility for annual equity awards. US-based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time-off package including vacation, personal days, holidays and other leaves. EEO & Accessibility
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for the application process or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and include the job requisition number in your message. Seniority level
Entry level Employment type
Full-time Job function
Information Technology Industries
Pharmaceutical Manufacturing
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