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Analytical Scientist - Nitrosamine

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Novartis

28d ago

  • Job
    Full-time
    Mid Level
  • Science
    Research & Development
  • Hyderabad, +1

AI generated summary

  • You need a PhD or MSc with 4+ years of experience, expertise in LC-UV/FID, Ion chromatography, and LCMS, good documentation skills, and knowledge of cGMP and de-formulation studies.
  • You will conduct experiments, document data, suggest designs, optimize methods, manage chemicals, collaborate with teams, mentor new hires, maintain equipment, and ensure compliance with guidelines.

Requirements

  • PhD on technical subject with relevant experience. or Master of Science with 4+ years of relevant experience
  • Fluency in English language.
  • Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
  • Broad theoretical and scientific knowledge in the relevant area (e.g. manufacturing, analytical, pharmaceutical).
  • Skilled scientist with expertise in trace level quantification of GTI/ Nitrosamines/Nitrites or similar impurities using LC-UV/FID, Ion chromatography and LCMS.
  • Experience on dealing OOS/OOE and deviations involving above mentioned analytical techniques.
  • Proficient with laboratory and/or technical tools.
  • Good knowledge of software and computer tools.
  • Good documentation skills.
  • Good knowledge of current Good Manufacturing Practices (cGMP)
  • Advanced scientific/technical writing skills
  • Wide experience on de-formulation studies of the drug products , especially in the microscopic evaluation of drug component.

Responsibilities

  • Meet quality, quantity and timelines in all assigned projects; Perform and document scientific experiments; Plan & organize scientific experiments under minimal guidance from more experienced team members. Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
  • Provide documentation of raw data; Evaluate and Contribute to interpretation and report results under minimal guidance from more experienced team members; Propose and provide input for the design of next experiments; Optimize existing methods (lab or plant) or contribute to new method development and reproduce published methods and develop more efficient ones.
  • Generate lab procedures, reports and/or instructions and/or SOP’s; Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls etc.; Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team member.
  • Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility.
  • Collaborate with other team members to facilitate deliveries of DS and/or DP; Act as mentors for new joinees.
  • Utilize special tools/equipments and/or specialized facilities e.g., containment/sterile labs; Evaluate new lab equipment; Schedule and perform routine maintenance and calibration of lab instruments/equipment & contribute to maintenance of infrastructure/equipment.
  • Actively participate in project teams/meetings/networks; Actively contributes to team goals.
  • Ensure all own activities are aligned with overall drug development process. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines; Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives.

FAQs

What is the primary role of an Analytical Scientist in this position?

The primary role of an Analytical Scientist involves planning and performing scientific experiments for the preparation and delivery of drug substances and drug products, collaborating within a multifunctional project team.

What qualifications are required for this position?

Candidates should possess a PhD in a technical subject with relevant experience or a Master of Science with 4+ years of relevant experience.

Is expertise in nitrosamines or related impurities necessary for this role?

Yes, expertise in trace level quantification of GTI/Nitrosamines/Nitrites or similar impurities using various analytical techniques is required.

What analytical techniques should candidates be familiar with?

Candidates should have experience with LC-UV/FID, Ion chromatography, and LCMS techniques.

Are there opportunities for mentorship in this position?

Yes, the role includes responsibilities to act as mentors for new joiners in the team.

What are the key responsibilities of this role related to safety and compliance?

The key responsibilities include ensuring safety in the handling of chemicals and compliance with current Good Manufacturing Practices (cGMP), as well as working according to appropriate SOPs, GLP, and other relevant guidelines.

Will the selected candidate need to generate lab procedures and reports?

Yes, the candidate will be responsible for generating lab procedures, reports, instructions, and SOPs.

How important is collaboration in this role?

Collaboration is essential, as the role involves working with other team members to facilitate deliveries of drug substances and drug products.

What is the work environment like for this position?

The work environment is primarily based in a laboratory setting, specifically in containment/sterile labs, with responsibilities including routine maintenance and calibration of lab instruments.

Is this position full-time or part-time?

This position is full-time.

Are there any specific software skills required for this job?

Proficiency with laboratory and technical tools as well as good knowledge of relevant software and computer tools is required.

Will there be opportunities for continuing education or professional development?

Yes, as a part of Novartis, there are opportunities for personal and professional development as noted in the benefits and rewards offered.

What is the location of this job?

The job is located in Hyderabad, India.

Is there support for individuals with disabilities during the recruitment process?

Yes, Novartis is committed to providing reasonable accommodation for individuals with disabilities during the recruitment process.

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Novartis

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right