Head of Sterile Manufacturing - Peptide Lyophilized Injectable Vials

Job Description

Title: Head of Sterile Manufacturing - Peptide Lyophilized Injectable Vials

Company Name: Raysun Biopharma Co., Ltd

Vacancy: 01

Age: 35 to 50 years

Job Location: Laos

Salary: Tk. 100000 - 200000 (Monthly)

Experience:

• At least 10 years

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• At least 10 years

• Age 35 to 50 years

**Required Experience**

- Minimum 10 years of experience in sterile injectable manufacturing.

- Strong hands-on experience with lyophilized injectable products, preferably vial-based sterile powder injections.

- Experience with aseptic filling lines, lyophilizers, vial washing machines, depyrogenation tunnels, autoclaves, clean utilities, HVAC, PW/WFI, clean steam, and compressed air systems.

- Proven experience in GMP plant startup, technology transfer, validation, and commercial production.

- Experience with media fill, aseptic process simulation, environmental monitoring, contamination control strategy, and sterile manufacturing risk assessment.

- Strong understanding of WHO GMP, EU GMP Annex 1, PIC/S GMP, or similar sterile manufacturing standards.

- Experience facing GMP inspections or customer audits is highly preferred.

- Previous experience as Production Head, Plant Head, Sterile Manufacturing Manager, Validation Head, or Technical Operations Head is preferred.

**Preferred Background**

- Experience in peptide injectable products, hormone products, biologics, or other sensitive sterile products.

- Experience in emerging-market GMP environments such as Bangladesh, India, Southeast Asia, or similar markets.

- Ability to work in a startup-style manufacturing environment and build systems from zero.

- Strong leadership, problem-solving, documentation, and cross-functional coordination skills.

**Education**

- Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Biotechnology, Microbiology, Chemistry, or related field.

- Advanced GMP, validation, or sterile manufacturing training is preferred.

**Language**

- English working proficiency is required.

- Chinese or Lao language is not required, but willingness to work in Laos is essential

**Position Summary**

Raysun Biopharma is building a dedicated sterile manufacturing platform for peptide lyophilized injectable vials. We are looking for an experienced senior leader to take full responsibility for the setup, qualification, validation, GMP operation, and continuous management of a sterile lyophilized powder workshop.

The ideal candidate must have hands-on experience from project startup to commercial GMP operation, including cleanroom layout, aseptic filling, lyophilization, equipment qualification, process validation, media fill, GMP documentation, team training, and regulatory inspection readiness.

**Key Responsibilities**

- Lead the full setup and operation of a sterile peptide lyophilized vial manufacturing workshop.

- Participate in clean room design review, process layout, personnel/material/waste flow design, and GMP compliance planning.

- Manage aseptic filling, vial washing, depyrogenation tunnel, stopper preparation, lyophilization, capping, inspection, labeling, and packaging operations.

- Lead equipment URS, FAT/SAT, installation, commissioning, IQ/OQ/PQ, process validation, cleaning validation, and media fill programs.

- Establish production SOPs, batch manufacturing records, cleaning procedures, line clearance procedures, deviation/CAPA systems, and GMP training programs.

- Ensure compliance with WHO GMP, EU GMP Annex 1 principles, and local regulatory requirements.

- Build and train the production, engineering, validation, and sterile operation teams.

- Support regulatory audits, customer audits, GMP certification, and export registration activities.

- Work closely with QA, QC, Engineering, Warehouse, and Regulatory teams to ensure smooth commercial production.

- Drive cost control, production efficiency, contamination control, and continuous improvement.