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 Ligand binding assay method development, qualification and validation of bioanalytical methods for both drug substance and drug product as per the protocol
- Coordinate with external laboratories for in-process HCP, metabolic assays and other outsourced assays, if any
- Compile data, analyze, troubleshoot and present
- Perform regular sample analysis for cGMP and development activities
- Perform protocol & report writing and ensure timely SOP revisions & related documentation
- Responsible for data analysis and data trending for the allocated assays
- Perform literature search for new molecules and finalize the best platform for assays
- Support in-vitro assay and RT-PCR on need basis
- Execute method transfer within the company and from outsourced companies
- Ensure on-time completion of work and compilation of data for review
- Ensure contemporaneous documentation of all tests (experiments, operational details and results) in lab notebooks or data sheets
- Responsible for equipment and inventory maintenance assigned by the manager
Key requirements
- Master’s in biochemistry or biotechnology or any relevant scientific discipline with minimum 5 years of experience in Ligand binding
- Ability to independently drive and manage development activities in order to meet the project requirements within the defined timelines
- Knowledge in formulation development by Quality by Design (QbD) approach
- Experience in handling scale-up issues during technology transfer from laboratory to manufacturing scale
- Expertise in formulation development of biologics with robust process and scalability
- Expertise in performing pre-formulation and formulation optimization studies
- Excellent working knowledge of cGMP regulations
- Proven track record of scientific publications, invited presentations, or invention disclosures / patents. At least one first or senior authorship publication in a reputable peer-reviewed journal
- Ability to work in teams, excellent verbal and written communication skills
Reference code: SRABA01