Junior Assistant Manager/ Assistant Manager in M.J. Biopharm Private Limited

Job Posted on Jan 17, 2023

Recruiter Type:Company
Company Name:M.J. Biopharm Private Limited
Address:Mumbai, Maharashtra
Contact Person:HR
Email Address:anuja.bhilare@mjbiopharm.com
Required in:Formulation
Job Department(s):Research
Job Title:Junior Assistant Manager/ Assistant Manager
Qualification:M. Pharmacy/ B. Pharmacy/ B.Sc. /M.Sc.
Job Details: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)
  • Literature survey
  • Strong knowledge base
  • Regulatory requirement
  • Pharmaceutical compliance
Regulatory Exposure:Not Required
Experience:8+ years

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