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
- Lead method development activities (in-process, drug substance and drug product) for the identified programs by defining developmental strategy, organizing resources, samples, people development, reporting, transfer and demonstration of the methods to the users
- Support in-process analysis for upstream and downstream development, stability, release etc., as needed, for the identified projects
- Responsible for analytical method development for quality and characterization of biosimilars using various analytical techniques including HPLC / UPLC, SDS Page, Bradford, LC-MS, LC-MS/MS, DSC, etc.
- Perform method qualification / verification / validation of development methods, including collating the results, reporting and finalization of the report
- Convert reports into user-friendly and detailed STPs / work instruction manuals for consistent and reproducible analysis
- Performing technology transfer from ADD to QCD and other labs
- Initiating action reports or deviation reports for any applicable non-conformance from the established procedures, investigating the cause for such incidents and converting the findings into meaningful reports; initiate any process / method improvement triggered from such events
- Provide a quality review process for the obtained data
- Facilitate first time right processes in the laboratory for high degree of precision, efficiency and quality of operations
- Collaborate with cross-functional teams, share the required information and feedback to enable informed decision making
- Adhere to the EHS guidelines and ensure good housekeeping standards
Key requirements
- Master’s degree in science or pharmacy or engineering with minimum 10 years of relevant experience
- Strong technical writing and verbal communication skills
- Experience in mentoring and developing junior scientific staff
- Ability to collaborate with cross-functional teams
Reference code: SCADD01