Designs, plans, authors, executes, and leads internal research & development studies in the Analytical Development Analytical Technology team. This position specifically focuses on driving method efficiency in Analytical Technology. Candidate will also author and assist in the execution of assay qualifications under very limited supervision. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and qualification activities.
• Designs, plans, leads, and executes R&D studies under very limited supervision.
• Documents research studies with a clearly defined purpose, methods and materials, results, and discussion.
• Writes research and development reports and ensures all data are reported clearly and accurately.
• Drafts and executes qualification protocols. Author qualification reports.
• Drafts method protocols and SOPs.
• Participates in assay transfers to Operations. Serves as trainer for inter and intradepartmental staff
• Evaluates new equipment, as needed.
• Author and execute IQOQ, author equipment SOP, as needed.
• Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs, as applicable.
• Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
• Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting.
• Serves as technical reviewer and LIMS tech manager.
• Presents data at internal staff meetings.
• Orders reagents and materials, as needed
• Initiate and track change controls
• Investigates and responds to equipment OOTs, as needed.
• Responsible for REES/ELPRO monitoring and response, as needed.
• PhD in Biological Sciences with 0-2 years of experience
• Must be highly skilled in biochemical assays including immunoassays.
• Experience with biologics characterization or separation technologies (HPLC, capillary electrophoresis, analytical ultracentrifugation, etc.) is highly desirable.
• Experience with gene therapy vectors and/or gene mediated cell therapy highly desirable.
• Mass spectrometry or light scattering experience is a plus.
• Automation experience is a plus.
• Understanding of a cGMP environment is 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 complex nature.
• Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.
• Excellent Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
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.