Formulation senior specialist

Formulation senior specialist :
Responsible for supporting the development and optimization of sterile pharmaceutical products, including parenteral, ophthalmic, and inhalation dosage forms, and contributing to scale-up and technology transfer activities in accordance with approved development strategies.
MAIN DUTIES AND RESPONSIBILITIES : Design, develop, and optimize sterile formulations for parenteral, ophthalmic, and inhalation products under defined project objectives and technical guidance. Conduct and document preformulating studies including solubility, p Ka, stability, drug–excipient compatibility, and excipient screening as part of development programs. Perform reverse engineering (DE formulation) studies of RLD formulations, including excipient identification and packaging assessment, with findings reported to the formulation lead. Support optimization of buffer systems, tonicity, p H, preservatives, antioxidants, and surfactants based on predefined formulation strategies. Evaluate adsorption risks and container–closure compatibility (glass, LDPE, PP, COP, BFS systems) and support extractables and leachables assessments. Execute and support sterilization approaches (autoclave, sterile filtration, aseptic filling) and assess their impact on product CQAs (assay, impurities, p H, particulates) under approved development plans. Support media fills, aseptic process simulations, and sterility assurance activities in coordination with manufacturing and quality teams. Support scale-up activities and contribute to the preparation and execution of batch records and technology transfer documentation. Participate in process validation activities and assist in troubleshooting formulation and process-related issues. Execute filtration studies, including evaluation of pre-filters and sterilizing-grade filters, with protocols reviewed and approved by senior staff. Prepare draft pharmaceutical development and formulation-related sections of the e CTD dossier for review and approval. Ensure personal adherence to GxP requirements and support compliant laboratory and manufacturing activities. Maintain flexibility to support operational requirements, including extended hours or shift work, when required.

Education:Bachelor’s degree in pharmaceutical science (Master degree is an advantage) Certifications:
Experience:5-10 Years
Job-related Skills:Strong experience in sterile formulation, BFS technology, sterile packaging systems, stability and degradation pathways. QbD, risk management, and process validation. Strong scientific and regulatory writing. Can do attitude.