Scientist - Analytical Science and Technology

Band Level 3   Job Description Summary The Analytical Science and Technology (AST) Scientist leads activities for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation.   Job Description Location: This position will be located in Durham, NC and is a full time onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Major Accountabilities: Leads method transfer, qualification/validation, trending across analytical network. Performs lab experiments for troubleshooting, development and validation efforts. Acts as analytical technical lead for one or more projects with guidance. Works closely with Analytical Development group to transfer/co-qualify new methods. Collaborate with internal and external testing labs to ensure successful completion of projects to the organizations' standards. Assists with authoring experimental protocols/reports and regulatory submissions related to analytical. Participates in assay troubleshooting and projects to improve method performance across network. Supports OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions. Assists with responses to agency questions related to analytical methods/specification. Other related QC and AS&T duties as assigned. Requirements: BS, in a relevant concentration with 6 years’ biopharmaceutical experience; MS with 4 years’ biopharmaceutical experience; Ph.D. with 1 year biopharmaceutical experience. Must have experience with Bioassays especially PCR methods (such as ddPCR).  Also preferable to have next generation sequencing and cell-based assay experience. Ph.D. is preferred GMP and Automation experience is a plus. Strong critical thinking and problem-solving skills. Experience with method development, transfer, qualification, and validation. Experience in gene/cell therapy field is a plus. Skills: Quality environment Business Partnering Operational Excellence Risk Management Stakeholder Management Collaboration Regulatory requirements knowledge Dealing with ambiguity Problem Solving Skills Leadership Communication skills Data Integrity Digital savviness Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Onsite   EEO Statement: 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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 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 tas.nacomms@novartis.com 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. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings   Salary Range $85,400.00 - $158,600.00   Skills Desired Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise