Designs, plans, leads, authors, executes, and interprets research & development studies, assay qualifications and test article validations. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and validation activities. Participates in client calls and face to face meetings with limited assistance by departmental senior staff. Leads and drives technical discussions both internally and externally. Interfaces with Sales team regularly and authors custom quotes as needed.
• Designs, plans, leads, executes (as needed), and interprets R&D studies. Leads projects.
• Designs, plans, drafts and executes (as needed) QP and VPs and other GMP methods. Author reports.
• Drafts client protocols/test methods.
• Participates in assay transfers to Operations. Serves as trainer for inter and intradepartmental staff
• Writes research and development reports and ensures data are reported clearly and accurately.
• Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
• Excels in method troubleshooting. Clearly communicates scientific knowledge internally and externally.
• Serves as technical reviewer and LIMS tech manager.
• Participates in client calls and face to face meetings as a subject matter expert.
• Leads and drives technical discussions.
• Interfaces with Sales team regularly.
• Authors custom quote sections, as needed.
• May informally oversee limited number of junior staff.
• Ordering reagents and materials, as needed
• Initiate and track change controls
• Investigates, responds and/or approves equipment OOTs
• Responsible for REES/ELPRO monitoring and response
• Author and execute IQOQ, author equipment SOP, as needed.
• Attends scientific conferences, when feasible.
• Maybe required to work Holidays and weekends
• Thorough understanding of Good Manufacturing Practices
• May be required to assist in other departments
• Bachelors’ degree in Biological Sciences or science related field with 8 years of experience or
• Master’s degree in Biological Sciences with 6 years of experience or
• PhD in Biological Sciences with 2 years of experience
• Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable.
• Specialized training in laboratory techniques used in assigned laboratory is required.
• Experience in a cGMP environment is highly desirable.
• Proven troubleshooting skills.
• Ability to use judgment as dictated by complexity of situation.
• Ability to work under limited supervision and to handle problems of a more difficult nature.
• Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook).
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.