About Stelis
Stelis Biopharma is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), with a complete and integrated end-to-end offering. We work side-by-side with our clients as true partners, with customer-centric collaboration and communication. We provide world-class process development and manufacturing infrastructure for both drug substance (mammalian and microbial-based therapeutic proteins and viral vectors) and drug product (lyophilized vials, liquid vials, pre-filled syringes, cartridges and devices). Our highly experienced quality and regulatory personnel help us meet global quality standards, ensure compliance and guide our clients through the regulatory approval process. Our three state of the art facilities are staffed by over 700 highly talented professionals. As the most agile CDMO in the industry, Stelis Biopharma is a trusted CDMO partner of choice. To learn more, visit www.stelis.com
Primary responsibilities
- Execute IQ, OQ and PQ of single use system, POD filtration, chromatography system, TFF, single use buffer preparation system in drug substance manufacturing areas
- Execute commercial manufacturing process up to 2KL scale by handling POD filtration, chromatography system, TFF and the single use buffer preparation system
- Ensure that batches are carried out as per the shifts and instructions following relevant SOPs and maintain appropriate documentation as per the cGMP guidelines
- Coordinate and complete the facility related activities to ensure seamless production
- Ensure upkeep of the facility for running the process and the related process equipment
- Participate in the discussions and execute downstream processing of other products with adequate training
- Collaborate with Engineering, QA and QC for smooth functioning of production activities
- Prepare quality documents such as, SOPs, BPRs and BMRs, etc.
- Ensure adherence to safety rules and practices in the company premises, identify unsafe conditions and develop mitigation plans
- Ensure that the area is anytime audit-ready
Key requirements
- Bachelor’s in biotechnology / chemical engineering or master’s in biotechnology with minimum 3 years of relevant experience
- Knowledge of cGMP and regulatory requirements of the biologics industry
- Demonstrated abilities to work in teams and collaborate with cross-functional teams
- Strong interpersonal and communication skills
Reference code: ASADSM01