PharmINT Associate Analytical Scientist

City: Basel
Country: Switzerland
Duration: 8 Months

Job Purpose:

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 Analytical Scientist is a specific and technical role, reporting the Global Pharmaceutical Intelligence and Forensics Manager at Global Security.

The PharmINT Analyst will work with advance the state of the art analytical techniques to primary gather spectrometric data to feed the spectra libraries of Novartis genuine. Initially, he/she will be contribute to the management of the life cycle and the chain of custody of Anti-counterfeiting exhibits and the execution genuine Drug Substances and Drug Products collection to support to support the spectral libraries development and maintenance.

He/she will work closely with PharmINT Forensics team to deliver the timely delivery to deliver spectra for methods development and maintenance to empower the authentication services. All work and assignments must be performed in adherence to Novartis high technical, environmen-tal, and health and safety standards.
This position will require close collaboration and substantial interaction with Global Security Associates as well as various internal stakeholders (i.e. NTO manufacturing sites, Technical Research Development, Quality).

Major Activities Accountabilities

1. Meet quality, quantity and timelines in all assigned Anti-counterfeiting operations, net-works and/or PharmINT Forensics services: Work on assigned priorities and to an agreed plan, through the systematic collection, spectroscopic data gathering according to appropriate SOPs, GMP, GLP, QM, HSE, and ISEC Novartis Guidelines into timely accu-rate and relevant PharmINT deliverables.
2. Collaborate with appropriate technical resources and experts to accelerate the libraries development.
3. Support the execution of the global genuine Drug Substances and Drug Products collec-tion to ensure to support the spectral libraries development and maintenance.
4. Support operations related to the development, validation, transfer and maintenance of accurate and traceable cross-divisional spectral libraries to support the development of robust multivariate/Chemometrics statistical methods for reliable, cost-efficient and real-time detection of counterfeit medicines:
a. Plan and manage the collection of genuine drug products covering the manufacturing (i.e. Sites and Variants)
b. Plan and manage the development, validation, transfer and maintenance of the spectral library.
c. Collect spectra of genuine samples using vibrational spectrometric techniques as per the library development plan
5. Support the inventory of incoming materials and exhibits to be processed by PharmINT Forensics Team
6. Handle exhibits collected during anti-counterfeiting operations and their chain of custody to ensure traceability of PharmINT Forensics services following the evidence life cycle process and guidelines.
7. Develop and maintain excellent working and reciprocal relationships with internal asso-ciates from other functions such as NTO and GDD to facilitate transfer of knowledge and deliveries of Drug Substances and Drug Products.

Education (minimum/desirable):

Chemical scientist (with bachelor or MSc in Life Sciences, forensics, Pharmacy or Medicines from accredited Technical University) or equivalent education with experience in pharmaceutical industry.

Languages: Fluent in English

Experience/Professional requirement:
1. 1-3 years’ experience undertaking similar roles in the Pharmaceutical Industry with a particular focus on analytical and forensic sciences as well as technology and quality Control. 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.
2. Excellent knowledge of laboratory and/or technical tools.
3. Proficient in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., spectrometers, handheld devices labs.
4. Good scientific and technical knowledge in analytical chemistry and galenical development.
5. Proficient in computational analysis of field measurement data with Python with data management and integration skills is a plus;
6. Clear record keeping skills with special attention to data traceability.
7. Experience working in a matrix environment with global, cross-functionally teams;
8. Quick learner, problem solver, working flexibly and in autonomy with solid written and verbal communication skills.
9. Profound literature search skills.

Specific Experience/Professional requirement:

1. Sound knowledge of the enterprise products portfolios (Innovative Medicines and Sandoz).
2. Proficiency in pharmaceutical formulation development and process engineering.
3. Comprehensive knowledge of SOP, cGMP, cGLP and Novartis regulations and policies.
4. Profound knowledge in analytical technology and equipment, including qualification and calibration
5. Experience in vibrational spectroscopy (e.g., NIR, FTIR, Raman) and multivariate statistics, machine learning, chemometrics.
6. Very good communication skills. Good presentation skills and scientific/technical writing skills. Advanced coaching skills.
7. Good knowledge of software and computer tools: Good know-how in common computer applications, e.g. databases, SAP,MS Office, SharePoint, as well as in laboratory specific applications, e.g. Chromeleon