$5500 + AWS + VB + allowance5 working days, Mon - Fri, normal office hoursLocation: WestResponsibilities
Oversee project planning, documentation, timelines, and budget management.
Coordinate internal and external activities related to the Quality section of dossiers.
Review technical documents from various teams for accuracy, compliance, and completeness for regulatory submissions.
Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings.
Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications.
Monitor activities of CMO/CDMO and provide CMC subject matter expertise.
Assist in vendor discussions, procurement processes, and shipment activities.
Identify inefficiencies and improve workflows to ensure the efficient operation of the CMC and Bio-analysis department.
Requirements
Bachelor\xe2\x80\x99s, Master, or PhD degree in Chemistry, Biochemistry, Pharmaceutical Sciences or relevant scientific discipline.
Minimum 5 years of relevant experience.
Knowledge of bioprocessing, functional assays and physiochemical characterization of monoclonal antibody is a plus.
Excellent communication and interpersonal skills.
Competitive remuneration package will be offered to the shortlisted candidate.Interested candidates, please send your updated CV in MS Words format stating your last drawn salary, expected salary, notice period and reason for leaving last / past employment(s) and email to recruit@caed.com.sg for priority processing.To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings.Please connect us via LinkedIn as follows for efficient messaging:Do Join us at TELEGRAM by searching \xe2\x80\x9cCAREER EDGE JOB OPPORTUNITIES\xe2\x80\x9d to receive fast job alert!Attn: Jace Tay (Registration No.: R1331152)CAREER EDGE ASIA PTE LTD EA Licence Number: 13C6678 To find out more job opportunities, visit Career Edge Asia at www.caed.com.sg for all job listings. Email: recruit@caed.com.sgSocial Share:More Information