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
- Projects planning and mapping of developmental activities as per organizational goals
- End-to-end project monitoring and coordination for developmental projects in R&D starting from project initiation to regulatory submission by tracking all major and critical milestones
- Design of experiments using DoE software-process control strategy finalization
- Procure raw materials, packing materials and consumables for multiple projects
- Preparation and review of documents such as, SOPs, protocols, formulation development reports, technology transfer documents, process descriptions, controlled strategy documents, etc. for the assigned projects
Key requirements
- Master’s in science or pharmacy with minimum 4 years of experience in formulations
- Sound knowledge and practical understanding of biologics formulation development
- Ability to independently drive and manage development to meet the project delivery timelines
- Knowledge in formulation development by Quality by Design (QbD) approach
- Experience in handling of the scale-up issues during technology transfer from laboratory to manufacturing
- Expertise in formulation development of biologics with robust process and scalability
- Expertise in performing pre-formulation and formulation optimization studies
- Good technical writing and communication skills
Reference code: RAFDD01