Mj Biopharma hiring – Executive – Formulation Development
Mj Biopharma hiring – Executive (Formulation Development)
Role: Executive – F&D (Injectable)
Education: M. Pharmacy
Roles and 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.
- Perform pre-formulation studies for biological products if needed along with innovator products characterization
- Plan and execute lab trails for formulation development of new biological injectable formulation projects as per product development timelines.
- To review analytical data generated during different stages of formulation development of new biological products.
- To plan and execute lab trial batches, 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
- Provide technical support to production during execution of commercial validation and for any trouble shooting during production.
- 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 Profile
Education: M. Pharmacy
Experience: min. 3 years in F&D (injectable)
Key Skills: F&D, Injectable/ Parenteral, Tech transfer, Literature survey, Literature review.
Application Process
Please email your CV at [email protected]
