Senior Scientist, Research and Product Development; Mandarin Speaking Analytical SME

Senior Scientist, Research and Product Development (Mandarin Speaking Analytical SME)

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The Research and Product Development (RPD) group at Steri Max Inc. is primarily responsible for dossier review, co‑development, in‑licensing & technical operations support of pipeline and commercial injectable portfolio across all aspects of the product lifecycle. The RPD group works closely with Regulatory Affairs, Quality & PMO to support execution and on‑timed delivery of projects and deliverables for global markets.

Reporting to the RPD Manager, the Senior Scientist is mainly responsible for the dossier review, support in addressing regulatory queries, analytical method development, method validation, and method transfers to support development of selected complex generic and biosimilar injectable pharmaceutical products. Working closely with multifunctional teams, the Senior Scientist will maintain laboratory operations and ensure that all work is performed in accordance with the applicable SOPs, cGMP’s and GLPs.

• Conduct comprehensive review of the CMC (Chemistry, Manufacturing, and Controls) sections in the dossiers and propose strategies to address any identified review gaps to minimize risk.
• Perform analytical method development, method validation, forced degradation studies and method transfers.
• Prepare analytical methods, protocols, reports and other documents related to analytical development and validation activities.
• Perform stability testing in accordance with ICH or other regulatory guidelines. Prepare and implement stability protocols and scheduling.
• Support formulation development for analytical testing related to stability, compatibility and pre‑validation studies.
• Perform root‑cause analysis including OOS and OOT and independently troubleshoot method‑related problems.
• To support regulatory team in responding to queries received from regulatory authorities.
• Keep up to date with scientific and technical developments.
• Analyze and interpret data making sure that data is accurately recorded in accordance with guidelines.
• Ensures compliance with Steri Max Corporate Quality Systems; along with local and global regulatory guidelines (e.g. ICH, GMP, GCP and GLP).

• Business level proficiency in both English and Mandarin.
• Minimum 10+ years of related experience in research and development area of pharmaceutical industry.
• Strong knowledge of analytical method development, method validation and method transfers using HPLC, GC, and other analytical techniques.
• Working knowledge and application of GMPs/GLPs principles, ICH guidelines and compendial methods, in addition to other related and relevant guidelines and regulations.
• Work independently and as part of a team.

Steri Max is an equal opportunity employer that is committed to fair and accessible employment practices for all staff and potential candidates. Please advise Human Resources if you require an accommodation to participate in the recruitment process.