Position Overview
Act as a bioanalysis scientist to conduct routine cell-based neutralized antibody (Nab) method development, validation and sample analysis in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.
Play a key role in designing and optimizing analytical methods for cell based Nab with supervisory assistance.
Capable of complex analyses using new methods/technology, with scientific guidance as needed.
Duties and Responsibilities:
Act as a bioanalysis scientist to conduct routine cell-based neutralized antibody (Nab) method development, validation and sample analysis in compliance with standard operating procedures (SOPs) and regulatory agency guidelines.
Play a key role in designing and optimizing analytical methods for cell based Nab with supervisory assistance.
Capable of complex analyses using new methods/technology, with scientific guidance as needed.
Documents work, maintains study documentation and laboratory records according to appropriate regulatory documentation practices.
Independently operates laboratory equipment, including system set up and general maintenance as directed by SOP. Capable of problem identification and issue resolution relating to equipment repair and submits work orders or maintenance requests as appropriate.
May provide input and participate in project meetings. This can include planning, monitoring, and guiding project work by effectively utilizing personnel and resources for timely completion of assigned projects.
Informs Study Director, Lead Scientist, and/or management of any problems or deviations that may affect integrity of the data; participates in corrective action of problems.
Contributes to a cohesive team environment. Plans individual assigned workload daily in coordination with team members, can effectively manage multiple assignments.
Identifies technical issues and proactively communicates them to the study team. Is capable of performing troubleshooting experiments and is an active participant in the design of troubleshooting experiments.
As a member of the cell core team, provide ideas, supports, and participates in process improvement initiatives for cell-based assay platforms.
Maintains a clean and safe laboratory work environment. Demonstrates understanding of Health and Safety compliance by ensuring that policies/SOPs and training are up to date.
Contributes to Policy, SOP, or guide writing and revising through peer review.
May train, mentor, or assist less experienced staff.
Participates in client visits and communicates method related or technical information as needed
Performs other related duties as assigned.
Minimum Education and Experience Required:
Master of Science (MS) degree plus at least 2-year applicable experience for cell-based assay.
Bachelor of Science (BS) degree plus at least 4-year applicable experience for cell-based assay.
The degree can be in Cell biology, molecular biology, pharmacology or related field.
Candidates with experience in bioanalysis are preferred.
Preferred Qualifications:
More than 2 years’ relevant laboratory experience with an MS degree in Cell biology, molecular biology, pharmacology or related field.
Rich experience in cell culture. Familiar with various mammalian cells culture operation process. Capable of performing standard aseptic operation experiments.
Ability to independently complete cytology experiments to support large molecule cell based Nab detection.
Independently conduct tests for chemistry projects and provide initial analysis of results, asking questions as needed.
Acts as a technical resource for the department (trouble shooting, method development, qualification, maintenance and training) with guidance as needed.
Maintains and operates laboratory equipment, including independent problem identification and resolution.
Evaluates data for incorporation into written reports.
Able to effectively communicate, both verbally and in writing.
Ability to assist in the preparation of relevant sections of final reports.
Skills and Competencies:
Computer Skills:
Ability to perform basic computer skills (e.g., Word, Excel).
Language Skills Required:
Speaking: Yes – English and Chinese
Writing/Reading: Yes – English and Chinese
Working Conditions:
May work with potentially hazardous substances and/or radioisotopes.
Mandatory immunizations and screening as required.
Travel Requirements: