Formulation Development - Biological Injectable | Pune

Preferred candidate profile

***Biologics experience mandatory

Role & responsibilities

• Literature survey for Regulated and other markets drug products and other activities for complete dossier as per regulatory requirement for Formulation Development of new biological injectable formulation.
• Plan and monitor pre-formulation studies for biological products if needed along with innovator products characterization through subordinate scientist.
• Plan and monitor lab trials through subordinate scientist for formulation development of new biological injectable formulation projects as per product development timelines.
• To review analytical data and compile generated during different stages of formulation development of new biological products.
• To plan and execute along with subordinate scientist R & D scale up, plant scale up, Tech transfer batches, exhibit batches and validation batches as tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements.
• To coordinate with CMOs (Contract Manufacturing Organization) for planning and executing external Tech transfer activities in manufacturing location of new biological injection formulations as per regulatory requirements.
• Provide technical support to production during execution of commercial validation and for any trouble shooting during production.
• Coordinate and support to Regulatory affairs team regarding product filing, query response and life cycle managements activities.
• Maintain stability record, responsible for stability data compilation and planning.
• Prepare of SOPs, PDR, BMR, MFR, stability protocol, stability report, process optimization protocol and report, TT protocol & Report, PV protocol & report.
• Monitor & maintain the store inventory for API, excipients and packaging material.
• Prepare and maintain of proper batch records, LNBs with all the compilation from F&D and ADL during product development.
• Perform activities related to new product regulatory filing and query response.
• Responsible to maintain good documentation practices, good lab practices and adherence to SOPs in Formulation Development Department.

Perks and benefits