Novartis Gene Therapies is dedicated to developing and commercializing gene therapies for patients and families devastated by rare and life-threatening neurological genetic diseases.
• Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Performs technical reviews of work performed by department staff for accuracy, completeness, and conformance to specifications; evaluation of new product processes; Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
• Delivers to assigned work schedule with attention to detail and accuracy.
• Supports site risk assessments and leads departmental audit walk-throughs.
• Supports trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
• Lab lead for major and critical departmental investigations, responsible for escalation of events and participates in cross-functional team.
• Recommends, leads, and follows up of corrective and preventative actions, which may include authoring new/revision of Standard Operating Procedures, Protocols / Summary Reports / Plans for QC.
• Owns the implementation of change controls to ensure compliance with regulatory requirements and company policies.
• Supports the development and maintenance of compliance-related documentation, including procedures, work instructions, and training materials.
• Identifies and leads improvement projects to drive improved capability, eliminate waste, and increase team performance.
Commitment to Diversity & Inclusion:
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Role Requirements
• Bachelor’s degree (preferred) in scientific disciplines such as Chemistry, Biochemistry, Biology, Microbiology, or relevant field with 5 years’ experience in GMP OR 8 years relevant experience in lieu of degree.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Extensive knowledge of GLP and GDocP principles.
• Possess strong understanding of QC testing operations and provide expertise in several QC assays.
• Ability to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions.
• Through knowledge of GMP requirements and FDA/EMEA regulations and ability to effective interactions/communication with Quality management.
• Experience in cell culture and cell-based assays (e.g., virus infection assays and proliferation assays) is desired.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture.
The pay range for this position at commencement of employment is expected to be between $40.39 and $60.58 Hourly; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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. You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.
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