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Sr. Research Associate Ii-Gmp Qcsr. Research Associate Ii-Gmp Qc

10+ years
Not Disclosed
10 Jan. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Research Associate II - GMP QC

Organization: Jubilant Biosys
Location: Greater Noida, India
Department: GMP Quality Control (QC)
Function: Quality Control


Company Overview:

Jubilant Bhartia Group is a global conglomerate with a strong presence across diverse sectors such as Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, and Consulting in Aerospace and Oilfield Services. With four flagship companies—Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited, and Jubilant Industries Limited—the group has a global workforce of around 43,000 employees.

Jubilant Biosys, a part of Jubilant Pharmova, specializes in drug discovery services and contract research, offering comprehensive solutions from target discovery to candidate selection. With a focus on oncology, metabolic disorders, CNS diseases, and inflammation, Jubilant Biosys collaborates with leading global pharmaceutical and biotechnology companies.


Position Summary:

Jubilant Biosys is seeking a highly skilled Senior Research Associate II to join our GMP Quality Control team. This position involves performing and leading various analytical tests, including HPLC, UPLC, GC, ion chromatography, and method development/validation for GMP pilot plant, scale-up, and R&D projects. The role also requires coordination with engineering teams for calibration management and supporting GMP compliance.


Key Responsibilities:

  • AMC and Calibration Management:

    • Coordinate with OEM vendors and the engineering team to execute the qualification, calibration, and requalification activities for QC equipment, ensuring timely execution and compliance.
  • Analytical Testing (HPLC, UPLC, GC, etc.):

    • Lead and perform analysis using UPLC, HPLC, GC, GC-HS-MS, ion chromatography, and other techniques for GMP pilot plant, scale-up, and other R&D samples.
    • Perform chiral analysis for GMP pilot plant, scale-up, and R&D samples.
  • Method Development:

    • Responsible for the development of analytical methods for various GMP pilot plant, scale-up, and R&D projects.
  • Method Validation:

    • Lead the method validation process for different GMP pilot plant, scale-up, and R&D projects, ensuring compliance with relevant standards.

Qualifications & Experience:

  • Educational Qualification:

    • Postgraduate degree in Science (preferably in Chemistry or related fields).
  • Experience:

    • 10 years of relevant experience in a GMP-controlled environment.
    • Strong experience in method validation, method development, and forced degradation.

Desired Skills:

  • In-depth knowledge and experience with analytical techniques including HPLC, UPLC, GC, GC-HS-MS, and ion chromatography.
  • Proven expertise in method development, validation, and troubleshooting.
  • Strong communication and collaboration skills to coordinate with internal teams and external vendors.
  • Ability to manage multiple tasks and prioritize effectively while adhering to GMP guidelines.

Equal Opportunity Employer:

Jubilant Biosys is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, ancestry, citizenship, color, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion, or any other characteristic protected by applicable local laws, regulations, and ordinary.