Lead Research Scientist - Liquid Lab
Lead Research Scientist - Liquid Lab
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: Lead Research Scientist Liquid Lab
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
About Apotex Inc.
Apotex Inc. is a Canadianbased global health company that produces highquality affordable medicines for patients around the world. Apotex employs almost 7200 people worldwide in manufacturing R&D and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration the Apotex group is focused on the development and sale of generic biosimilar and specialty products.
For more information visit: .
Job Summary
To supervise scaleup exhibit and process validation batches for successful execution and ensure the efficient transfer of technology of products developed at Apotex Research Pvt. Ltd.
Job Responsibilities
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Apotex Inc. is a Canadianbased global health company that produces highquality affordable medicines for patients around the world. Apotex employs almost 7200 people worldwide in manufacturing R&D and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration the Apotex group is focused on the development and sale of generic biosimilar and specialty products.
For more information visit: .
Job Summary
To supervise scaleup exhibit and process validation batches for successful execution and ensure the efficient transfer of technology of products developed at Apotex Research Pvt. Ltd.
Job Responsibilities
- Responsible for techtransfer of injectable and ophthalmic formulations from R&D to commercial scale
- Gap analysis To evaluate the product feasibility technology feasibility at manufacturing site along with gap analysis with available technology for site readiness
- Documentation – Onsite documentation and timely execution of scaleup exhibit and validation batches
- Risk assessment – To carry out the risk assessment to identify the impact of critical process parameters and critical material attributes
- To design and review the sampling plan for scaleup process optimization and submission batches
- To study and verify the parameters established during development are still with in the determined design space in scaleup and exhibit batches
- To coordinate with other departments at plant in completing scaleup and exhibit batch related activities
- In coordination with CMO and PM ensure the availability of raw materials packaging materials filters tubings etc. required for scaleup exhibit and commercial batches before initiation of execution
- Compile the batch orsevations and prepare the report of scaleup EB and commercial/PV batches
- To ensure smooth technology transfer of products developed at Apotex to CMO
- Technical support to formulation development team
- Involve in formulation development activities and assist in development of scaleable manufacturing process
- Review and compilation of the developmental plant scale batches data and stability results
- Coordination with different crossfunctional teams like AD procurement QA packing regulatory affairs project management for smooth execution of scaleup batches
- Coordination with external labs for successful completion and receipt of studies data performed for plant scale batches
- Review of MFR BMR BPR stability protocols study protocols and reports Executed BMR BPR
- Issuance maintenance writing review of raw data completeness check and archival of laboratory notebook
- Coordination with vendor and internal service engineer for installation calibration maintenance and trouble shooting
- Report to next level manager regarding day to day activities.
- Preparation of SOPs and ensure compliance as per SOP
- Take up any other work as allotted
- Education
- D /M Pharma in Pharmaceutics/B.Pharma.
- Knowledge Skills and Abilities
- Must have experience in development and techtransfer of injectable and ophthalmic and complex drug products
- Effective command over verbal and written communication with good interpersonnel skills.
- Engage with CMO partners and support the group submission plans
- Proficient in MS office and advanced software tools.
- Having well versed knowledge on regulatory guidelines
- Able to priortise the task best in effective planning of work activities to meet the timelines.
- Experience
- Minimum 6 to 10 years of experience in Injectable and Ophthalmic dosage forms in area of Development Manufacturing and technology transfer expertise for CMO.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
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Employment Type
Full Time
Key Skills
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