Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Pharm INT & Forensics Manager
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 & Forensics manager is a highly specialized and technical role, reporting func-tionally to the Global Head of Anti-Counterfeiting and operationally to the Global Pharmaceutical Intelligence and Forensics Manager at Global Security. The PharmINT & Forensics manager is Spectroscopic Scientist who will advance the state of the art spectrometers to primary run spectrometric authentication of suspicious products and sec-ondary support the development of spectral libraries. Initially, he/she will be responsible for ap-plying conventional and innovative approaches to detect counterfeit/falsified products using vi-brational spectroscopy in order to support anti-counterfeiting operations and investigations. 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, spectral libraries 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 devel-opment, 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 As-sociates as well as various internal stakeholders (i.e. NTO manufacturing sites, Technical Re-search & Development, Quality).
Major Activities & Accountabilities
1. Contribute to the global management of the differential forensic assessment and testing pro-cedures (TP) of a wide variety of physical pharmaceutical evidences including the manage-ment of the evidence’s chain of custody. Ensure that all instrumental, quality, and forensic da-ta are consistent with reported results of analysis. Autonomously perform statistical calcula-tions to verify or validate analysis results as required;
2. Ensure appropriate escalation to responsible management in case of critical findings as per Current valid Standard Operating procedures and working instructions; 3. Run authentication operations to detect counterfeit medicines in fast and real time detection.
4. Contribute to the management of the overall differential forensic assessment and testing pro-cedures (TP) of a wide variety of physical pharmaceutical evidences including the manage-ment of the evidence’s chain of custody.
5. Support operations related to the development, validation, transfer and maintenance of accu-rate and traceable cross-divisional (group wise) spectral libraries to support the development of robust multivariate/chemometrics statistical methods for reliable, cost-efficient and real time detection of counterfeit medicines. Support the evaluation of new technologies for coun-terfeit detections.
6. Provide expert policy advice on all matters related to spectral libraries’ collection, validation, release and maintenance, including Legal and Quality aspects. Use Pharmaceutical intelli-gence and operational forensics products to influence engagement with internal and external partners.
7. 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.
Pharmacist (with MSc or Ph.D. in Life Sciences, forensics, Pharmacy or Medicines from accredited Technical University) or equivalent education with experience in pharmaceutical industry.
1. 2-3 years’ experience undertaking similar roles in the Pharma-ceutical Industry with a particular focus on analytical and foren-sic sciences as well as technology and quality Control. Opera-tional 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.
2. Sound experience in vibrational spectroscopy (e.g., NIR, FTIR, Raman) and multivariate statistics (e.g., regression analysis for classification or property calibration), machine learning, chemo-metrics.
3. Proficient in computational analysis of field measurement data with Python with data management and integration skills is a plus;
4. Clear record keeping skills with special attention to data tracea-bility.
5. Experience working in a matrix environment with global, cross-functionally teams;
6. Quick learner, problem solver, working flexibly and in autonomy with solid written and verbal communication skills.
7. Sound knowledge of the enterprise products portfolios (Innovative Medicines and Sandoz).
8. Sound knowledge of multivariate statistical tools and analytical method development and validation.
9. Proficiency in pharmaceutical formulation development and process engineering.
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.
11. Profound knowledge in analytical technology and equipment, including qualification and calibration
12. Good know-how in common computer applications, e.g. databases, SAP,MS Office, SharePoint, as well as in laboratory specific applications, e.g. Chromeleon
Experience : 2-3 years
Qualification : M.Sc, Ph.D
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Legal & Intellectual Property & Compliance
End Date : 20th February, 2020
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