Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post : Group Leader-Formulation Development
Job Summary
• Responsible for Planning, organizing and supervising, product and process development work which meets all the regulatory requirements and aim to develop cost conscious formulations, Prioritize and execute the product development activities to meet the project timelines efficiently.
• Supervising formula optimization and process optimization employing the concept of Quality by Design (QbD) and create the design space. Identification of Quality Target Product Profiles, Critical Material Attributes, Critical Process Parameters and its effect on drug product Critical Quality Attributes, during the initial drug product development stage.
• Review the documents for the execution of submission batches and review the regulatory documents for submissions.
• Responsible for preparing and reviewing the documents required for the execution of submission batches, monitor and involve in the troubleshooting of submission batches (if any). Prepare and review the regulatory documents required for the submission.
• To be Responsible for checking of calibration of instruments, Qualification of Equipment’s and supports the system in updating the SOPs and formats.
• Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
Job Responsibilities
- To review and supervise the Literature search of the Development Projects.
- To be responsible for performing Patent search, develop non-infringing formulae, manufacturing process and generate patent evaluation report.
- To prepare Formulation Development Strategies for adhering to the set-up timelines.
- To supervise preformulation studies and manufacture prototype batches.
- To develop, monitor and validate new formulations and provide support for existing products.
- To assist the Deputy Manager in the day-to-day functioning of the Formulation Development Department.
- To generate and revise various documents like Standard Operating procedures, Formats, Protocols, reports, Master Formula, Packing Order Masters (POMs) etc., for the Formulation Development Department.
- To be responsible for conducting the troubleshooting of formulations / products in terms of composition (Formulation) and process (method of manufacturing) issues.
- Should apply design of experiments (DoE) in developing formulations and processes according to US FDA’s Quality by design (QbD) requirements.
- To prepare batches for stability studies on laboratory scale and Pivotal batches for stability and Bioequivalence studies.
- To prepare and revise Departmental Standard Operating procedures (SOPs) and formats and to ensure that the SOPs are in line with actual work procedures.
- To be responsible for all activities in the Formulation Development laboratory including cGMP, documentation and implementation of departmental Quality Systems.
- To provide technical support during technology transfer of project from lab scale to pilot / pivotal scale.
- To propose specifications for Raw materials, packing materials, In-process and finished products.
- To indent and organize sufficient raw materials and packaging materials required for execution of development and submission batches.
- To develop and design tooling / artwork / shade cards for tablets / capsules.
- Stability monitoring of development / submission batches as per ICH guidelines.
- Involve in the selection and evaluation of packing materials suitable for submission batches.
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Candidate Profile
Education: Master Degree in Pharmacy with specialization in Pharmaceutics / Industrial pharmacy
Experience: Minimum 8 to 10 years of Experience in Formulation development for regulated market.
Required to have the knowledge on formulation development of Solid oral dosage forms for regulated markets like USA, Europe, Canada and Australia. Desirable to have Formulation Development knowledge on Injectable, NDDS, semisolids and Liquids. Should have a good understanding of Product development process and pharmaceutical testing. Shall have understanding of Quality by Design and Planning of experiments using DoE is desirable. Must have good understanding of clinical and regulatory requirements of USA, Canada, Australia, and European regulatory bodies. Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
Other Information:
Experience: 8 to 10 year
Location: Bengaluru/Bangalore
Education: M.Pharm
Industry Type: Pharma/biotech/Clinical research
Functional Area: Formulation Development
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