Pharmaceutical Method Development Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeAnalytical Full time ₹ 1,04,000 - ₹ 1,30,878

Job Summary:

We are seeking an Analytical Development Expert to join our team.

  • The ideal candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products.
  • This role will involve extensive use of chromatography techniques and adherence to regulatory standards.
Responsibilities:
  • Review relevant literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods.
  • Develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples.
  • Address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities.
  • Ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development.
  • Develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
  • Prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed.
  • Conduct forced degradation studies to identify potential impurities and establish their chemical nature and behavior.
  • Perform real-time analysis of samples during product development stages to ensure product quality and consistency.
  • Compile stability data to assess the stability profile of products under various conditions.
  • Evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process.
  • Identify and plan for developmental needs of the product, considering factors such as scale-up and potential process improvements.
  • Sources and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment.
  • Ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
  • Calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.
  • Maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
  • Keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements.
Qualifications:
  • Masters in Science/ Organic chemistry
  • Minimum 4 years of experience in analytical method development
Skills & Attributes:
  • Technical Skills
  • Experience in Process Optimization (Manufacturing)
  • Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques
  • Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis
  • Proven experience in method validation and documentation in compliance with regulatory requirements
  • Behavioral Skills
  • Excellent communication and interpersonal skills
  • Strong analytical and problem-solving abilities
  • Ability to work collaboratively with own team and cross-functional teams

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