Assistant Manager / Deputy Manager / Scientist
- Nadsoft
- 6 - 11 years
- Mumbai
- 14 hours ago
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Job Description
Sr. Research Scientist / Assistant Manager / Deputy Manager
Department: FRD (OSD Oral Solid Dosage)
Experience: 812 Years
Role Overview:
This is a critical role within the Formulation R&D function, responsible for leading the development of Oral Solid Dosage (OSD) formulations from concept to commercialization. The incumbent will drive formulation strategies, ensure robust product development, and enable successful scale-up and regulatory submissions in line with global standards.
Key Responsibilities:
Formulation Development & Strategy:
- Lead end-to-end development of OSD formulations including tablets, capsules (IR, SR, MR, gastro-retentive systems).
- Design scientifically sound formulation strategies based on API characteristics and QbD principles.
- Conduct pre-formulation studies including solubility, compatibility, and excipient selection.
Execution & Scale-Up:
- Plan and execute lab-scale trials, pilot batches, and exhibit batches.
- Drive scale-up activities and ensure reproducibility across manufacturing scales.
- Troubleshoot formulation and process-related challenges with data-driven approaches.
Regulatory & Documentation:
- Prepare and review development reports, product development summaries, and technical documents.
- Contribute to regulatory filings (ANDA, Dossier, DMF) in compliance with USFDA, EU, WHO, and other global requirements.
- Ensure data integrity and adherence to GLP, GMP, and internal SOPs.
Cross-Functional Collaboration:
- Work closely with Analytical R&D, QA, QC, Production, and Regulatory Affairs teams.
- Support technology transfer activities to manufacturing sites.
Leadership & Project Management:
- Lead project timelines and ensure on-time delivery of development milestones.
- Mentor and guide junior scientists and research associates.
- Drive continuous improvement and innovation within the FRD function.
Candidate Profile:
- M.Pharm / B.Pharm (Pharmaceutics preferred).
- 812 years of hands-on experience in OSD formulation development.
- Strong exposure to regulated markets (US/EU).
- Sound knowledge of QbD, scale-up, and regulatory expectations.
- Strong analytical thinking, leadership, and stakeholder management skills.
Scientist / Sr. Research Associate / Research Associate
Department: FRD (OSD Oral Solid Dosage)
Experience: 26 Years
Role Overview:
This role focuses on execution of formulation development activities for oral solid dosage forms, supporting senior scientists in delivering robust and scalable pharmaceutical products.
Key Responsibilities:
Formulation Execution:
- Conduct formulation development trials for tablets and capsules.
- Perform granulation (wet/dry), compression, coating, and encapsulation processes.
- Assist in developing prototype formulations based on defined strategies.
Pre-formulation & Evaluation:
- Conduct compatibility studies, dissolution profiling, and stability studies.
- Evaluate physical and chemical parameters of formulations.
Documentation & Compliance:
- Maintain accurate laboratory notebooks and development records.
- Prepare protocols, reports, and summaries in compliance with regulatory standards.
- Follow GLP, data integrity norms, and internal SOPs.
Support Activities:
- Assist in scale-up batches and exhibit batch manufacturing.
- Coordinate with Analytical R&D for sample testing and method support.
- Participate in troubleshooting and process optimization activities.
Candidate Profile:
- M.Pharm / B.Pharm (Pharmaceutics preferred).
- 26 years of relevant experience in OSD formulation.
- Hands-on exposure to lab-scale equipment and processes.
- Good documentation practices and analytical mindset.
Sr. Research Scientist / Assistant Manager (Team Lead)
Department: FRD (Technology Transfer)
Experience: 712 Years
Role Overview:
This role will lead the Technology Transfer (TT) function, ensuring seamless transition of products from R&D to commercial manufacturing. The incumbent will play a key role in scale-up, validation, and process optimization while ensuring compliance with regulatory standards.
Key Responsibilities:
Technology Transfer Leadership:
- Lead end-to-end TT activities for OSD products from R&D to plant scale.
- Develop and execute TT strategies, protocols, and timelines.
Scale-Up & Validation:
- Oversee scale-up batches, exhibit batches, and process validation activities.
- Ensure consistency and robustness of processes during commercial manufacturing.
Documentation & Compliance:
- Prepare TT protocols, reports, process validation documents, and risk assessments.
- Ensure compliance with regulatory expectations (USFDA, EU, WHO).
Cross-Functional Coordination:
- Act as a bridge between R&D, production, QA, QC, and regulatory teams.
- Resolve technical challenges during manufacturing and validation stages.
Team Management:
- Lead and mentor the TT team.
- Drive performance, accountability, and continuous improvement initiatives.
Candidate Profile:
- M.Pharm / B.Pharm with strong experience in TT and manufacturing.
- 712 years of experience in pharma OSD domain.
- Strong knowledge of scale-up, validation, and regulatory requirements.
- Excellent leadership, problem-solving, and communication skills.
Scientist / Sr. Research Associate / Research Associate
Department: FRD (Technology Transfer Junior Team)
Experience: 26 Years
Role Overview:
The role supports technology transfer operations by assisting in scale-up, validation, and coordination between R&D and manufacturing teams.
Key Responsibilities:
Execution Support:
- Assist in execution of TT batches including exhibit and validation batches.
- Support manufacturing during product transfer and initial commercial runs.
Documentation:
- Prepare and maintain TT documentation including protocols, reports, and batch records.
- Ensure proper recording of deviations, observations, and corrective actions.
Coordination:
- Work closely with production, QA, and QC teams during TT activities.
- Ensure timely availability of materials, documents, and resources.
Compliance & Quality:
- Ensure adherence to SOPs, GMP, and regulatory requirements.
- Support audit readiness and documentation reviews.
Candidate Profile:
- M.Pharm / B.Pharm (Pharmaceutics preferred).
- 26 years of experience in TT / manufacturing / FRD support.
- Good understanding of manufacturing processes and documentation practices.
- Strong coordination and execution capabilities.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Research ScientistEmployement Type: Full timeContact Details:
Company: NALocation(s): Mumbai
Keyskills: Oral Solid Dosage Formulation R&D Immediate Release Tablet Development OSD Batch Manufacturing Record Sustained Release Technology Transfer Research And Development Scale-Up
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