Biological Injectable formulation development (R&D-Drug Product)
Roles and Responsibilities
Literature survey for Regulated and other markets drug products and other activities for the 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.
Desired Candidate Skills:
Biological Injectable formulation development (Mandatory)
