Novartis Hiring for Manufacturing Science & Technology (MS&T) Specialist job in Millburn Full Time

Job Description
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 entry level professionals to help us reach our ambitious goals.

Location: On-site

The MS&T Specialist supports MS&T team on sites by collecting data, reviewing or writing technical documents related to validation (e.g. process validation, ongoing process verification, cleaning validation, packaging), APR PQR, technical files, product risk assessment procedures and maintaining a product oversight throughout the lifecycle.

• Support Validation program including process validation, ongoing process verification (OPV), risk assessments. Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning validation protocol/reports based on alignment with Site Validation Lead.
• Using monitoring tool such as OPV Monitor or Discoverant perform, OPV evaluations, assess process performance and provide insight, recommendation, and conclusion to the site MS&T Lead/Product Steward.
• Create and review GxP documents including SOPs, working procedures, trend reports, and technical investigations, as and when needed.
• Support tasks related to technical changes, incident investigations for the product and process. Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports. Coordinate & manage project for a smooth knowledge transfer activity from site/ function to Operations Center.
• Coordinates documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.
• Obtains deviation reports from relevant systems in support to validation to enable conclusions.
• Execute qualification activities for Vaporized Hydrogen peroxide decontamination and equipment testing.
• Coordinates and owns DI check with Data integrity manager where applicable.
• Coordinates inputs from respective functions (QA, QC, MS&T), to create the validation documents and decide on the study strategy.
• Coordinates the execution of the study with respective functions. Collects results and creates reports.

Minimum requirements
• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical engineering, or equivalent scientific degree.
• Experience in process support, e.g. MS&T role, Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC.
• Proven process understanding (Pharma, GMP, Validation and Regulatory aspects).
• Sound experience of data handling and applied statistics is a must.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team building and process harmonization skills
• Excellent verbal and written communication skills
• Excellent problem solving and decision-making skills
• Defining and implementing productivity improvement measures.

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: People and Culture | Novartis.

Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23 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.

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