Biological Injectable formulation development (R&D-Drug Product) Job openings in mj biopharma
Biological Injectable formulation development (R&D-Drug Product) Job openings in mj biopharma
Role: Biological Injectable formulation development (R&D-Drug Product)
Designation: Junior Assistant Manager/ Assistant Manager
No. of vacancies: 01
Experience: min. 8 years
Education: M. Pharmacy/ B. Pharmacy/ B.Sc. /M.Sc.
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 the new biological injectable formulation.
- Plan and monitor pre-formulation studies for biological products if needed along with innovator product characterization through subordinate scientists.
- Plan and monitor lab trials through subordinate scientists 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.
- Coordinate with CMOs (Contract Manufacturing Organizations) for planning and executing external Tech transfer activities in the manufacturing location of new biological injection formulations as per regulatory requirements.
- Provide technical support to production during the execution of commercial validation and for any troubleshooting during production.
- Coordinate and support to Regulatory affairs team regarding product filing, query response, and life cycle management activities.
- Maintain stability record, responsible for stability data compilation and planning.
- Prepare SOPs, PDR, BMR, MFR, stability protocol, stability report, process optimization protocol and report, TT protocol & Report, and PV protocol & report.
- Monitor & maintain the store inventory for API, excipients, and packaging material.
- Prepare and maintain of proper batch records, and 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)
- Literature survey
- Strong knowledge base
- Regulatory requirement
- Pharmaceutical compliance
APPLICATION PROCESS; Please email us your CV at [email protected]
