Enzene Biosciences
Website:
enzene.com
Job details:
Roles and Responsibilities:
Manage a team of 6ñ10 members, ranging from Senior Scientists to Interns, providing leadership, guidance, and workload planning.
Plan and assign work for direct reportees, review their timesheets, and ensure timely completion of tasks.
Coordinate with cross-functional teams and the Analytical and Testing (AAT) team, representing AAT in internal meetings.
Oversee and troubleshoot analytical techniques, including HPLC, Capillary Electrophoresis (CE), and SoloVPE, while ensuring data review and interpretation.
Possess knowledge of advanced characterization methods, such as Mass Analysis, Circular Dichroism (CD), Fluorescence Spectroscopy (Flr), Differential Scanning Calorimetry (DSC), and Multi-Angle Light Scattering (MALS), which would be an added advantage.
Conduct and oversee method qualification for HPLC, CE, and SoloVPE-related techniques.
Prepare and review documents such as Method Qualification Protocols (MQP), Methods of Analysis (MOA), Method Qualification Reports (MQR), specifications, and analytical similarity studies.
Prepare source documents for regulatory submissions to EMA and USFDA, with prior experience being an additional advantage.
Draft and communicate client query responses while ensuring timely updates to cross-functional teams.
Experience & Qualifications:
Qualification: M.Sc or Ph.D.
and relevant years of experience in analytical methods for biopharmaceuticals.
Technical Skill Requirements:
Proficient in HPLC-based methods such as Size-Exclusion HPLC (SE HPLC), Cation Exchange HPLC (CEX HPLC), Poly 20 measurement, and Reverse Phase HPLC (RP HPLC).
Skilled in Capillary Electrophoresis (CE)-based techniques, including CE SDS (Reducing and Non-Reducing) and Capillary Isoelectric Focusing (CIEF). Experience with CE analysis on the Maurice system is a plus.
Proficient in SoloVPE analysis and data interpretation.
Soft Skill Requirements:
Fluent in English with strong communication skills.
Approachable and able to effectively lead and collaborate with a team.
Capable of presenting technical data in internal meetings and facilitating work by coordinating with cross-functional teams.
Adept at technical review of data and ensuring timely communication to relevant teams.
Able to resolve and escalate conflicts within the team in consultation with the manager.
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