Formulation Specialist - Inhalation

Job Summary

• You will be responsible for end to end Formulation development of Inhalation including development, execution, filing and approval.
• You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections.
• You will be responsible to support in scale-up to pilot/plant scales for Injectable Products.
• You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions.
• You will be responsible for technologytransfer and execution of the batches.
• You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,processes designing and scale up).
• You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documentsfor drug product at every stage of development.
• You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materialsand ensure development studies are performed related to regulatory and internal system requirements. 

Educational qualification:

• Have work experience on Formulation Development and expertise in inhalation dosage form.
• Experience in areas of product development for Generic Injectable
• Experience in Quality by Design (QbD).
• Experience in Process Optimization and scale up.
• Experience in Operational Excellence.
• Knowledge on Good Manufacturing Practice and Good Laboratory Practice.
• Experience in Technology Transfer. 

Behavioral

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams. 

About the Department

Integrated Product Development Organisation

Benefits Offered