Executive/Sr Executive/Junior Manager - Formulation development (OSD)

MSN Group; Hyderabad; On-site; INR 700,000 - 1,200,000; Full time

Job summary

MSN Laboratories Pvt. Ltd. in Hyderabad seeks qualified professionals with 4-8 years of hands-on experience in Oral Solid Dosage formulation development. The role covers development, scale-up, tech transfer, and regulatory documentation in compliance with GMP.

Responsibilities include developing tables/capsules, optimizing formulations, DoE/QbD approaches, and cross-functional collaboration with Analytical R&D, IPQA, Production, and Regulatory teams.

Qualifications

• 4-8 years of hands-on experience in Oral Solid Dosage (OSD) formulation development.
• Strong experience in tablet and/or capsule formulation development and optimization.
• Knowledge of QbD, QRM, DoE and GMP documentation.
• Experience in scale-up and technology transfer.

Responsibilities

• Develop and optimize oral solid dosage formulations, including tablets and capsules.
• Execute formulation development activities from screening through scale-up and commercialization.
• Plan and execute laboratory-scale, pilot-scale and manufacturing batches.
• Coordinate with Analytical R&D, IPQA, Production, Engineering, Packaging and Regulatory Affairs teams.
• Ensure GMP, GLP, SOPs compliance and regulatory documentation.

Skills

OSD formulation

Tablet formulation

Capsule formulation

QbD/QRM/DoE

GMP knowledge

Analytical skills

Communication

Education

M.Pharm / M.S. (Pharm) / B.Pharm

Pharmaceutics specialization

Job description

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.
• Good 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