Principal Scientist

Responsibilities

• Provide technical expertise and leadership in planning, designing, and conducting experiments, analyzing data and documenting results towards development and optimization downstream processes and/or achieving goals for cross functional development teams
• Provide technical expertise and leadership in the technologically innovative efforts of the relevant project teams
• Supervise setup, operation, and routine maintenance of AKTA, Process skid and equipment. Monitor processes to ensure consistency and reliability
• Work independently, analyze and interpret experimental data, and present/document experimental results at meetings. Provide reports and prepare scientific presentations as needed
• Write/revise batch records and technical reports
• Play a lead role in strategically maintaining group awareness of relevant scientific literature and new technologies and business trends
• Participate in/lead the evaluations of new technologies and their potential applications and business impacts
• Maintain substantial knowledge of state-of-the art principles and theories and contribute knowledge base through literature review, conferences attendance and publication
• Provide excellent judgements in the decision-making processes existing in the execution of a project
• Play a lead role in providing technical coaching (matrix management) of and motivating junior staff members to high performance by providing mentoring, training, and appropriate supervision in process development activities
• Manage resource planning and projects with excellent financial, timing, and priority awareness

Qualifications

• Ph.D./MS/BS degrees in biochemistry, biomedical/biochemical engineering, or a closely related field
• Ph.D. with ≥11 years or MS with ≥14 years or BS with ≥16 years of experience in downstream process development, scale-up and tech transfer to cGMP manufacturing facility in biotechnology
• SME in designing, developing/optimizing/characterizing chromatography, ultrafiltration/diafiltration, viral filtration/inactivation, and formulation for biologics drug substances development
• Strong hands-on experience with AKTA purification systems (purifier, explorer, AKTA Pilot and Process skid) is required, ability for AKTA equipment trouble shooting is required
• SME with ion exchange, hydrophobic, mixed mode and affinity chromatography with AKTA purification systems, TFF process and filtration development
• Excellent strategic views in judging business trends & their potential impacts, and proactive attitude to learn new technologies and manage changes in process development and process scale-up
• Proven excellent management experience and leadership aptitude, and excellent financial awareness
• Client focused, quality, results, productivity, and efficiency oriented, and science and innovation driven
• Advanced written skills
• Attention to detail, and the ability to multitask
• Proficient with the use of MS Office software (MS Excel, MS Word, MS Powerpoint) and statistical DOE software including JMP, Minitab, Design Expert etc)
• Flexible and results oriented