02 Oct
|
MSN Group
|
Hyderabad
02 Oct
MSN Group
Hyderabad
Role & responsibilities
Executive / Senior Executive / Junior Manager Formulation Development (OSD)
Company: MSN Laboratories Pvt. Ltd.
Location: Pashamylaram, Hyderabad, Telangana
Experience: 4–8 Years
Function: Formulation Development – Oral Solid Dosage (OSD)
Designation: Executive / Senior Executive / Junior Manager
Job Summary
We are looking for qualified and experienced professionals with 4–8 years of hands-on experience in Oral Solid Dosage (OSD) formulation development to join our Formulation Development team at Pashamylaram.
The role involves formulation development and optimization, execution of laboratory and pilot-scale trials, scale-up, technology transfer, troubleshooting, and preparation of technical documentation in compliance with applicable regulatory and GMP requirements.
Key Responsibilities
- Develop and optimize oral solid dosage formulations, including tablets and capsules.
- Execute formulation development activities from initial formulation screening through scale-up and commercialization.
- Perform pre-formulation studies, excipient compatibility studies and prototype development.
- Select suitable excipients and optimize formulation composition based on product requirements.
- Plan and execute laboratory-scale, pilot-scale and exhibit/engineering batches.
- Optimize critical formulation and process parameters to achieve desired product quality attributes.
- Develop and optimize processes such as:
- Direct compression
- Wet granulation
- Dry granulation
- Compression
- Film coating
- Encapsulation
- Evaluate blend, granule, tablet and capsule properties and troubleshoot formulation/process-related issues.
- Apply QbD,
QRM and DoE principles wherever applicable during formulation development.
- Prepare and review formulation development protocols, reports, batch records and other technical documents.
- Analyze development data and prepare scientifically sound conclusions.
- Coordinate with Analytical R&D;, IPQA, Production, Engineering, Packaging and Regulatory Affairs teams.
- Support scale-up and technology transfer activities from R&D; to manufacturing.
- Participate in troubleshooting during scale-up, exhibit, validation and process optimization batches.
- Support stability studies and evaluation of formulation performance.
- Ensure all development activities comply with GMP, GLP, SOPs and applicable regulatory requirements.
- Support preparation and review of technical documentation for regulatory submissions.
- Maintain accurate laboratory records, development data and associated documentation.
- Contribute to timely completion of assigned formulation development projects.
- For Junior Manager-level roles, provide technical guidance to junior team members and coordinate assigned development activities.
Required Skills & Experience
- 4–8 years of relevant experience in pharmaceutical formulation development – OSD.
- Strong hands-on experience in tablet and/or capsule formulation development.
- Good knowledge of pre-formulation,
excipient selection and formulation optimization.
- Hands-on experience in granulation, compression, coating and/or encapsulation processes.
- Experience in formulation trials, scale-up and technology transfer.
- Knowledge of QbD, QRM, DoE and pharmaceutical development principles.
- Experience in troubleshooting formulation and manufacturing process issues.
- Good understanding of GMP requirements and pharmaceutical development documentation.
- Strong analytical, technical and problem-solving skills.
- Positive communication and cross-functional coordination abilities.
Educational Qualification
- M.Pharm / M.S. (Pharm) / B.Pharm from a recognized institution.
- Candidates with a specialization/background in Pharmaceutics / Formulation Development will be preferred.
Preferred Experience
- Immediate-release and modified-release formulations
- Tablets and capsules
- Wet granulation / dry granulation / direct compression
- Film coating
- Formulation optimization and troubleshooting
- Scale-up and technology transfer
- QbD / DoE-based formulation development
- Stability studies and product characterization
- Regulatory documentation for generic pharmaceutical products
Key Competencies
- Formulation development expertise
- Technical problem-solving
- Scientific approach to product development
- Documentation and technical report writing
- Cross-functional collaboration
- Project and time management
- Team coordination and mentoring
- Attention to detail
Work Location: Pashamylaram, Hyderabad, Telangana Experience: 4–8 Years
Designation: Executive / Senior Executive / Junior Manager
Function: Formulation Development – OSD
📌 Executive/Sr Executive/Junior Manager - Formulation development (OSD) (Hyderabad)
🏢 MSN Group
📍 Hyderabad