PHARMA JOB AND LEARNING - Bhagwan Das Vaishnav
Role : Scientist – Formulation Development - Oral Solids
Reporting To : Tech Lead Work Location : IPDO, Hyderabad Purpose: To develop the product formula for Oral Solid Dosage Forms, ensure successful pilot & pivotal bio study, process optimization, scale-up and exhibit, respond to deficiencies.
Key Responsibilities:
§ Design the scheme of experiments. Interpret the results from various analytical instruments like HPLC, UV, GC, IR, etc.
§ Visualize the developmental needs of the product.
§ Perform experiments for establishing the compatibility between API and excipients.
§ Carry out stability at each stage of formulations development.
§ Submit samples for conducting pilot and pivotal Bio studies on the PE batch and Exhibit batches respectively in consultation with Biopharmaceutics Team.
§ Understand the safety and environmental aspect.
§ Solve the problems and queries related to the development of the formulation and discuss them with the Tech Lead.·
§ Understand/familiarize with the problems faced during Scale-up.
§ Understand the scalability of the chosen process.
§ Analyze the formulation strategy, efficiency, working relations and cross-functional issues in R&D.
§ Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs.
§ Keep the work area clean and the laboratory under controlled temperature.
§ Maintain the documents well.
Key Personal Attributes:
§ Excellent communication & Coordination skills and ability to work with a diverse cross-functional teams.
§ High energy & ability to work in ambiguity
§ Excellent interpersonal skills; high level of proficiency in networking internally and externally
§ Good data analytical skills with creative thinking ability
Knowledge:
§ Formulation Development-Displays understanding of physical & chemical properties of materials used in formulations and applications to own area through relevant pre-formulation studies.
§ Process Engineering-Demonstrates understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ products
§ Integrated Drug Development-Demonstrates awareness of Dr Reddy's business, products and research approach as well as competitors’ drugs/ products to aid product selection process/ support functional delivery
§ Regulatory & Compliance-Shows awareness of GXP guidelines, SOPs and internal systems related to own tasks & applies the same in daily operations effectively
§ IP Laws & Patents-Shows awareness of IP processes with relation to submission and approval
Operating Network:
Internal: FRD, ARD, PEF, PMO, RA, IP, Bio CoE, SCM, FTO, DQA External: Development partners (CMO/CRO)
Experience & Education: M Pharm with 1-4 years of experience. Should have gained experience in end-to-end product development / process development of Oral Solid dosage forms and delivered 2-3 products overall.
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IPDO
6
Formulation, Development
Role : Scientist – FR&D - OSD
Reporting To : Tech Lead Work Location : IPDO, Hyderabad Purpose: To develop the product formula for Oral Solid Dosage Forms, ensure successful pilot & pivotal bio study, process optimization, scale-up and exhibit, respond to deficiencies.
Key Responsibilities:
§ Design the scheme of experiments. Interpret the results from various analytical instruments like HPLC, UV, GC, IR, etc.
§ Visualize the developmental needs of the product.
§ Perform experiments for establishing the compatibility between API and excipients.
§ Carry out stability at each stage of formulations development.
§ Submit samples for conducting pilot and pivotal Bio studies on the PE batch and Exhibit batches respectively in consultation with Biopharmaceutics Team.
§ Understand the safety and environmental aspect.
§ Solve the problems and queries related to the development of the formulation and discuss them with the Tech Lead.·
§ Understand/familiarize with the problems faced during Scale-up.
§ Understand the scalability of the chosen process.
§ Analyze the formulation strategy, efficiency, working relations and cross-functional issues in R&D.
§ Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs.
§ Keep the work area clean and the laboratory under controlled temperature.
§ Maintain the documents well.
Key Personal Attributes:
§ Excellent communication & Coordination skills and ability to work with a diverse cross-functional teams.
§ High energy & ability to work in ambiguity
§ Excellent interpersonal skills; high level of proficiency in networking internally and externally
§ Good data analytical skills with creative thinking ability
Knowledge:
§ Formulation Development-Displays understanding of physical & chemical properties of materials used in formulations and applications to own area through relevant pre-formulation studies.
§ Process Engineering-Demonstrates understanding of engineering principles & process controls related to equipment and processes across scales to transfer or receive processes/ products
§ Integrated Drug Development-Demonstrates awareness of Dr Reddy's business, products and research approach as well as competitors’ drugs/ products to aid product selection process/ support functional delivery
§ Regulatory & Compliance-Shows awareness of GXP guidelines, SOPs and internal systems related to own tasks & applies the same in daily operations effectively
§ IP Laws & Patents-Shows awareness of IP processes with relation to submission and approval
Operating Network:
Internal: FRD, ARD, PEF, PMO, RA, IP, Bio CoE, SCM, FTO, DQA External: Development partners (CMO/CRO)
Experience & Education: M Pharm with 1-4 years of experience. Should have gained experience in end-to-end product development / process development of Oral Solid dosage forms and delivered 2-3 products overall.
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Hyderabad, Telangana, India
M.Pharm
1 to 4 Years
03-Apr-2019
Scientist
Job posted by - Pharma Job and Learning
Job posted by - Pharma Job and Learning
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