Officer/Trainee - MS&T

Anthea Pharma; Hyderabad; On-site; INR 500,000 - 750,000; Full time

Job summary

Anthea Pharma is seeking a Trainee/Officer - MS&T to support technology transfer from R&D to the manufacturing site in Hyderabad. You will coordinate scale-up, prepare and review TT docs, and collaborate with multiple departments to ensure regulatory compliance and timely product introduction.

The role involves batch records, SOPs, and QMS activities, with emphasis on cross-functional coordination, GMP knowledge, and hands-on support during execution of scale-up and exhibit batches.

Qualifications

• B.Pharm / M.Pharm / M.Sc. with 3 years in pharmaceutical manufacturing, Technology Transfer or MS&T.
• Experience in batch record preparation, production compounding, and IPQA batch monitoring.
• Familiarity with R&D development activities.
• Strong cross-functional coordination and communication skills.
• Understanding of regulatory and GMP requirements.

Responsibilities

• Coordinate transfer of products from R&D to the manufacturing site.
• Review and finalize TT documents from R&D and external partners.
• Liaise with site teams to ensure readiness and approval of TT documents.
• Identify and address technical gaps for smooth new product introduction.
• Prepare and review batch records, protocols, and reports for scale-up batches.
• Monitor and provide technical support during scale-up and exhibit batches.
• Support regulatory team with required documentation for filings.
• Ensure availability of all materials (API, raw materials, packaging, consumables).
• Oversee sampling and stability testing as per approved protocols.
• Prepare and review SOPs; ensure compliance with cGMP guidelines.
• Assist production and quality teams during batch execution activities.
• Support QMS activities including deviations, CAPAs, and change controls.

Skills

Batch record preparation

IPQA batch monitoring

Cross-functional coordination

Communication skills

Regulatory and GMP knowledge

Education

B.Pharm / M.Pharm / M.Sc. (3 yrs TT/MS&T)

Job description

Job Title:

Trainee/Officer - MS&T / Technology Transfer to support the successful transfer of new products from R&D to the manufacturing site. The role involves coordination of scale-up and exhibit batches, documentation preparation, technical support during execution, and collaboration with various departments to ensure timely and smooth product introduction and regulatory compliance.

Key Responsibilities:

• Coordinate the transfer of products from R&D to the manufacturing site.
• Review and finalize technology transfer documents from R&D and external partners.
• Liaise with site teams to ensure readiness and approval of all TT documents.
• Identify and address technical gaps for smooth new product introduction.
• Prepare and review batch records, protocols, and reports for scale-up batches.
• Monitor and provide technical support during execution of scale-up and exhibit batches.
• Support the regulatory team by providing required documentation for product filings.
• Ensure availability of all required materials (API, raw materials, packaging, consumables).
• Oversee sampling and stability testing as per approved protocols.
• Prepare and review SOPs; ensure compliance with cGMP guidelines.
• Assist production and quality teams during batch execution activities.
• Support Quality Management System (QMS) activities including deviations, CAPAs, and change controls.

Qualification, Experience and Skills required:

• B.Pharm / M.Pharm / M.Sc. with 03 years in pharmaceutical manufacturing, Technology Transfer or MS&T
• Experience in batch record preparation, production compounding, and IPQA batch monitoring.
• Familiarity with R&D development activities.
• Strong cross-functional coordination and communication skills.

Understanding of regulatory and GMP requirements.