Manager - MSAT(Sterile Formulations)

Anthea Pharma; Telangana; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Anthea Pharma in Telangana, India seeks a seasoned Technology Transfer specialist to coordinate R&D to manufacturing tech transfers, scale-up and exhibit batches, and ensure regulatory compliance.

You will prepare and review batch records, SOPs and transfer documents, support QA/QMS activities, and liaise with site teams to ensure readiness and timely product introductions. 10–15 years’ experience in TT/MS&T required; strong cross‑functional coordination and GMP knowledge.

Qualifications

• 10–15 years in pharmaceutical manufacturing, TT or MS&T.
• Experience with batch record preparation and IPQA monitoring.
• Familiar with R&D development activities.
• Strong cross-functional coordination and communication.
• Understanding of regulatory and GMP requirements.

Responsibilities

• Coordinate TT from R&D to manufacturing.
• Review TT documents from R&D and partners.
• Liaise with site teams for TT readiness.
• Identify technical gaps for new product intro.
• Prepare and review batch records and protocols.
• Provide technical support during scale-up and exhibit batches.
• Support regulatory filings with required docs.
• Ensure availability of materials (API, packaging, consumables).
• Oversee sampling and stability testing per protocols.
• Prepare and review SOPs; ensure cGMP compliance.
• Assist production and QA during batch execution.
• Support QMS deviations, CAPAs, changes.

Skills

Cross-functional coordination

Regulatory compliance

GMP knowledge

Technical documentation

Batch records

Education

B.Pharm / M.Pharm / M.Sc

Job description

Role & responsibilities

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.

Preferred candidate profile

• B.Pharm / M.Pharm / M.Sc. with
• 10-15 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.