Executive
Executive
rubicon research limited- Posted 11 hours ago
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Job Description
Job Description
Purpose
Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and ROW. Perform duties in accordance with Rubicon policies and procedures.
Position / Job Title
Executive
Department
Formulation Development
Reporting To
Manager
Location
Thane
Years Of Experience
5+ years
Dosage Form
Solid Orals / Liquid Orals
Job Responsibilities / Deliverables
Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolved or new formula issues.
Design and execute formulation trials and evaluate stability data to finalize formulation composition.
Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc.
Support the manufacturing of exhibit/submission batches per regulatory requirements.
Support technology transfer for manufacturing processes from laboratory scale to production scale.
Guide to junior team members for routine activities.
Works with Analytical Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs.
Qualifications & Pre-requisites
Minimum master's degree in pharmaceutical sciences with 6+ years relevant experience.
Candidate should have hands on/practical experience in development, technology transfer and ANDA submissions for solid/ liquid oral dosage forms (solutions, suspensions, tablet, capsules) for regulated and semi-regulated markets like US, Europe and ROW.
Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry.
Male candidate is preferred (considering hormonal product handling)
Additional Notes
Expected to work in any of the shifts based on the requirement.
Expected to visit manufacturing site whenever required.
Expected to work in potent molecule development laboratory.
Purpose
Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and ROW. Perform duties in accordance with Rubicon policies and procedures.
Position / Job Title
Executive
Department
Formulation Development
Reporting To
Manager
Location
Thane
Years Of Experience
5+ years
Dosage Form
Solid Orals / Liquid Orals
Job Responsibilities / Deliverables
Responsible for formulation and process development of Oncology and hormonal products of oral dosage forms (Oral solid and Oral liquid formulations). Troubleshooting and problem-solving of unresolved or new formula issues.
Design and execute formulation trials and evaluate stability data to finalize formulation composition.
Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc.
Support the manufacturing of exhibit/submission batches per regulatory requirements.
Support technology transfer for manufacturing processes from laboratory scale to production scale.
Guide to junior team members for routine activities.
Works with Analytical Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs.
Qualifications & Pre-requisites
Minimum master's degree in pharmaceutical sciences with 6+ years relevant experience.
Candidate should have hands on/practical experience in development, technology transfer and ANDA submissions for solid/ liquid oral dosage forms (solutions, suspensions, tablet, capsules) for regulated and semi-regulated markets like US, Europe and ROW.
Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry.
Male candidate is preferred (considering hormonal product handling)
Additional Notes
Expected to work in any of the shifts based on the requirement.
Expected to visit manufacturing site whenever required.
Expected to work in potent molecule development laboratory.
More Info
Key Skills
About Company
Skills:
SAP, Ms Office, GMP documentation, Iso 14001, dls, quality compliance, API manufacturing process monitoring, Dcs, deviations, PQ, OQ, Change Control, validation processes, safety protocols, re-qualification process, Cleaning Validation, Capa
Skills:
pharmaceutical manufacturing processes, data integrity rules ALCOA, FDA rules like 21 CFR Part 11, GxP Good Practice Quality Guidelines, pharmaceutical CSV validation assignments
Skills:
Risk Mitigation, Compliance, process development, Stakeholder Management, Reporting
Skills:
SAP TM, Integration, Abap Programming, Configuration, Data Migration, Transportation Management, Custom Development, Process Optimization, Analytical Skills, Problem Solving