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Process Expert - MFG Investigations (Wed-Sat)
Location:
Millburn, NJ
Description:
Job Description Summary This role is located onsite in Millburn, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals with Quality expertise to help us reach our ambitious goals. As a Process Expert you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions. Job Description Key Responsibilities: Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed. Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers. Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging. Ensure processes are inspection ready at all times. Support process optimization and new technology introduction for continued productivity improvement, as appropriate. Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. Provide guidance and support to production team through training and knowledge sharing. Shift: This shift schedule for this role is Wed-Sat , 10am-8:30pm OR 1pm-11:30pm, located on-site at our Millburn, NJ location. Essential Requirements: Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree. 3 years' experience in a process support shop floor role in GMP manufacturing and/or QA/QC. Proven process understanding (Pharma, GMP, Regulatory aspects). Demonstrated in-depth experience with manufacturing related investigations required. Strong affinity with and awareness of quality issues. Excellent technical writing skills Desirable Requirements: Previous Radio pharma experience a plusThe pay range for this position at commencement of employment is expected to be between $84,000 to $126,000 per 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.Benefits and rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies 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 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 XXXX@novartis.com call +1 (877)395-XXXX 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 $84,000.00 - $126,000.00 Skills Desired Change Controls, Chemical Engineering, Continual Improvement Process, Deviation Investigations, General Hse Knowledge, Good Documentation Practice, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Root Cause Investigations, Six Sigma, Standard Operating Procedure (SOP)
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Process Expert - MFG Investigations (Wed-Sat) is a Other Jobs Process Expert - Mfg Invest Job at Novartis located in Millburn NJ. Find other listings like Process Expert - MFG Investigations (Wed-Sat) by searching Oodle for Other Jobs Process Expert - Mfg Invest Jobs.
Process Expert - MFG Investigations (Wed-Sat) is a Other Jobs Process Expert - Mfg Invest Job at Novartis located in Millburn NJ. Find other listings like Process Expert - MFG Investigations (Wed-Sat) by searching Oodle for Other Jobs Process Expert - Mfg Invest Jobs.