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
- Plan and execute method development using HPLC / UPLC, CE, FTIR, CD, MZE, LCMS etc.
- Organize the results, data, trends, method finalization and report writing
- Perform method qualification / verification / validation, protocol writing, execution and report writing
- Responsible for Standard Test Procedures (STP) and Raw Data Sheet (RDS) preparations
- Prepare protocols and execute Biocomparability & Characterization studies comprising both in-house and outsourced activities, data interpretation / analysis and report writing
- Ensure technology transfer of analytical methods from ADD to QCD or other sites for in-process testing, release testing of drug substance, drug product etc., as per the guidelines
- Initiate action reports or deviation reports for any applicable non-conformance
- Ensure data reviewing process with high degrees of accuracy
- Adhere to the EHS guidelines and ensure good housekeeping standards
Key requirements
- Master’s in biochemistry or biotechnology with minimum 3 years of relevant experience in analytical development
- Proven abilities to organize, assess and communicate complex information
- Abilities to analyze the data to make decisions in his / her area of work
- Ability to design experiments and draw meaningful conclusions from lab data
- Experience working with cross-functional teams
- Project management experience is an added advantage
- Ability to think logically, investigate and solve problems in a clear and concise manner
Reference code: RAADD01
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
- Plan and execute method development using HPLC / UPLC, CE, FTIR, CD, MZE, LCMS etc.
- Organize the results, data, trends, method finalization and report writing
- Perform method qualification / verification / validation, protocol writing, execution and report writing
- Responsible for Standard Test Procedures (STP) and Raw Data Sheet (RDS) preparations
- Prepare protocols and execute Biocomparability & Characterization studies comprising both in-house and outsourced activities, data interpretation / analysis and report writing
- Ensure technology transfer of analytical methods from ADD to QCD or other sites for in-process testing, release testing of drug substance, drug product etc., as per the guidelines
- Initiate action reports or deviation reports for any applicable non-conformance
- Ensure data reviewing process with high degrees of accuracy
- Adhere to the EHS guidelines and ensure good housekeeping standards
Key requirements
- Master’s in biochemistry or biotechnology with minimum 3 years of relevant experience in analytical development
- Proven abilities to organize, assess and communicate complex information
- Abilities to analyze the data to make decisions in his / her area of work
- Ability to design experiments and draw meaningful conclusions from lab data
- Experience working with cross-functional teams
- Project management experience is an added advantage
- Ability to think logically, investigate and solve problems in a clear and concise manner