Novartis

About Novartis

The global Pharmaceutical Intelligence (PharmINT) & Forensics strategy is fully embedded in the Novartis Anti-Counterfeiting program, which is destined to combat pharmaceutical crime and create the conditions to bring counterfeiters and illegal traders to justice, recover losses through legal action, improve patient safety, preserve Novartis reputation and create a tangible return on investment for the business. The PharmINT Senior Manager is a highly specialized and technical role, reporting to the Global Pharmaceutical Intelligence and Forensics Manager at Global Security. The PharmINT Senior manager is a Spectroscopic Data Analyst who will advance the state of the art data sciences and digital tools including machine learning, artificial intelligence to automate the spectrometric authentication of suspicious products. He/she will be responsible for implementing innovative approaches to detect counterfeit/falsified products using vibrational spectroscopy in order to support anti-counterfeiting operations and investigations. Under the leadership of the Global Pharmaceutical Intelligence and Forensics Manager, he/she will work closely with PharmINT & Forensics team to contribute to the authentication methods development and maintenance to empower the authentication services. He will work to timely build and maintain accurate, comprehensive cross-divisional, authentication methods to support fast spectrometric authentication related to worldwide pharmaceutical forensic investigations for the Anti-Counterfeiting Center of Excellence at Global Security. Specific duties will include development, validation, release and maintenance of spectra for counterfeit detection methods (i.e. vibrational spectroscopy such as Raman, FTIR, NIR as well as multivariate statistical analysis) using the authentication platform assets. All work must be performed in adherence to Novartis high technical, environmental, and health and safety standards. This position will require close collaboration and substantial interaction with Global Security associates as well as with various internal stakeholders (i.e. Quality, Tech Ops, and Pharmacovigilance). Major Activities & Accountabilities 1. Closely partner with the Global Pharma Intelligence and Forensics Manager to align activities and ensure they are closely connected with the Anti-Counterfeiting strategy 2. Lead the global management of machine learning methods and algorithm of a wide variety of pharmaceutical products founded on their spectral libraries to support to support industry changing topics such as Predictive Analytics, Machine Learning and Artificial Intelligence 3. Lead the delivery cost-efficient and comprehensive results for pharmaceutical intelligence collection operations: Autonomously discover, design, and develop analytical methods to sup-port novel approaches of data and information processing: work with large complex data sets to solve difficult, non-routine analysis problems applying advanced analytical methods includ-ing robust machine learning, multivariate/chemometrics statistical techniques for reliable and real time detection of counterfeit medicines; conduct end-to-end analysis that includes data gathering and requirements specifications, processing, analysis, ongoing deliverables and presentations; iteratively improve algorithms based on state-of-the-art machine learning mod-els; maintains machine learning routines and algorithms and perform explanatory data analy-sis including historical data to identify patterns; Keep abreast of the latest scientific develop-ments; 4. Prepare detailed documentation to transfer knowledge and satisfy governance and regulatory concerns; 5. Lead the maintenance of the integrated cross-divisional, pharmaceutical forensic devices and the end-users networks; 6. Perform evidence profiling from pharmaceutical and forensic assessments to highlight crimi-nal patterns, signatures or modus operandi to leverage anti-counterfeiting investigations of linked cases through data analysis and data mining; 7. Collaborate with business partners to understand needs, recommend enhancements and de-ploy predictive analytics across multiple platforms 8. Provide expert policy advice on all matters related to machine learning development, valida-tion, release and maintenance, including Legal and Quality aspects. Use Pharmaceutical intel-ligence and operational forensics products to influence engagement with internal and external partners. 9. Maintain and further build knowledge of local and international regulatory and legislative re-quirements and trends to provide expert advice and appropriate technical support on all qual-ity and legal related matters. 10. Promote the department in line with the global security strategy by representing Global Secu-rity as a trustworthy and authentic business partner that provides essential value-added ser-vices. Key Performance Indicators (Indicate how performance for this job will be measured) 1. High quality, timeliness and targeted robust differential forensic assessments, reports and briefing pertaining to alleged counterfeit incidents; 2. Development, validation, maintenance and deployments of cross-divisional authentication methods for counterfeit detection across Novartis divisions using cutting edge multivariate statistical methods, innovative technologies and integrated proficient pharmaceutical differential forensic assessment admissible in courts; 3. Track record of innovative machine learning and other sound digital innovations and realistic implementation timelines; 4. Ability to work autonomously and successfully in a cross-functional, matrix, project led environment: active with a strong sense of ownership, a responsive and flexible style. Minimum requirements Education (minimum/desirable): Successful candidate must have a Bachelor's degree in Chemistry, Biology, or Biochemistry with 5-10 years of professional experience; or a Ph.D. or Master's degree in Chemistry, Biology, Biochemistry, Statistics, or Data Science with 0-3 years of professional experience. Successful candidate must have significant experience in software programming/scripting for scientific data analysis. Languages: Fluent in English, other languages desirable Experience/Professional requirement: 1. 5-10 years’ experience undertaking similar roles in the Pharma-ceutical Industry or others with a particular focus on applied da-ta science in analytical chemistry and forensic sciences as well as machine learning development and implementation. 2. Proficient in computational analysis of field measurement data with Python with data management and integration skills; Ma-chine Learning (PCA, PLS...), chemometrics, including coding, problem solving and data analysis skills; Coding skills in Python are strongly required. 1. Extensive knowledge of data modelling and machine learning techniques (supervised and unsupervised learning, recom-mender systems, natural language processing, computer vision, etc.) 2. Extensive skills with programming/analytical tools (Python, R, SAS, Matlab, etc.) is highly desired; 3. Experience cleaning and processing data (structured, unstruc-tured) 4. Strong skills with data querying tools (SQL, DB2, Hive, Pig etc.) 5. Sound experience in vibrational spectroscopy (NIR, FTIR, Ra-man...); Operational experience should include manufacturing, forensic, QA/QC management, development or other relevant experience e.g. working at a regulatory health authority and/or law enforcement are a plus 6. Experience working in a matrix environment with global, cross-functionally teams: experience articulating business questions, using mathematical techniques to arrive at an answer using available data, and translating technical/analysis results into business recommendations 7. Strong ability in self-learning, entering new domain, managing through uncertainty in an innovative team environment: Quick learner, problem solver, working flexibly and in autonomy with solid written and verbal communication skills. Passionate and self-motivated. 8. Ability to work in collaborative multiple project team environ-ment and ship production features in a fast-paced environment. 9. Excellent communication (written and verbal), presentation, and facilitation skills 10. Customer/end result/Metrics driven in design and development: ability to manage multiple goals and deadlines Specific Experience/Professional requirement: 1. Proficiency in computing skills including Python, data management including databases and integration skills: Machine Learning (PCA, PLS...), chemometrics; 2. Extensive knowledge of data modelling and machine learn-ing techniques (supervised and unsupervised learning, rec-ommender systems, natural language processing, computer vision, etc.) 3. Extensive experience with programming/analytical tools (Py-thon, R, SAS, Matlab, etc.) is highly desired; 4. Extensive Experience cleaning and processing data (struc-tured, unstructured) 5. Extensive Experience with data querying tools (SQL, DB2, Hive, Pig etc.) 6. Sound knowledge of multivariate statistical tools and analytical method development and validation; 7. Sound knowledge in analytical chemistry technology is a plus; 8. Sound knowledge of the enterprise products portfolios (Innovative Medicines and Sandoz) is plus 9. Proficiency in pharmaceutical formulation development and process engineering is a plus: 10. Sound knowledge in pharmacopoeia compendia, good knowledge of current legal and regulatory requirements and guidelines (ICHQ8, ICHQ9, and ICHQ10)Comprehensive knowledge of cGMP and cGLP are plus’s 11. Sound knowledge in analytical technology and equipment, including qualification and calibration is a plus 12. Good know-how in common computer appl Division PHARMA Business Unit AMAC Work Location Mumbai Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Legal & Intellectual Property & Compliance Job Type Full Time

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Legal Form: AG

Company Type: Public

Company Size: 10001 - 50000

Revenue: > 10 billion (USD)

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