Senior Research Development Specialist

Analytical research senior specialist :

Responsible for supporting the development and validation of analytical methods for sterile pharmaceutical products, including parenterals, ophthalmic solutions, and inhalation products, and contributing to method lifecycle management under established procedures and supervision.

MAIN DUTIES AND RESPONSIBILITIES

• Support the development and optimization of analytical methods for sterile drug products and APIs (assay, Related Substances) under established protocols and guidance.
• Assist in establishing stability-indicating methods for parenteral, ophthalmic, and inhalation products as part of the analytical development team.
• Support extractables, leachables, and adsorption studies for glass and polymer-based containers (LDPE, PP, COC, COP).
• Execute method validation/verification activities in accordance with ICH Q2(R2), USP <1225>, Ph. Eur., and SFDA guidelines under supervision.
• Prepare draft validation protocols, reports, and statistical evaluation for review and approval.
• Perform testing of APIs, excipients, formulation trials, stability samples, and pilot batches for sterile dosage forms as assigned.
• Support design and interpretation of stability studies for sterile products following established ICH climatic zone protocols.
• Perform forced degradation studies under hydrolytic, oxidative, thermal, and photolytic conditions as per study plan.
• Support evaluation of the impact of sterilization on product CQAs (pH, potency, impurities, particulates).
• Support the transfer of analytical methods to the QC laboratory for sterile products under supervision.
• Prepare draft analytical sections of the eCTD dossier for review and approval.
• Ensure personal adherence to GxP standards and support compliance in laboratory activities.
• Demonstrate flexibility to support operational requirements, including extended hours or shifts when required.

Education:

Bachelor’s degree in Pharmacy or Chemistry (a master’s degree is an advantage)

Certifications:

Experience:

3-10 Years

Job-related Skills:

• Strong experience using HPLC, GC, ICP, and atomic spectroscopy.
• Strong scientific and regulatory writing.
• OOS – OOT investigation.
• Can do attitude.