Performs research & development activities and assay validations as required under supervision. Clearly documents all experiments according to SOPs and cGMP guidelines. Authors test methods and other technical documents, as needed. Performs laboratory maintenance duties. Works closely with Testing Operations during assay transfer and validation activities.
* Executes R&D studies planned with supervisor or technical lead
* Executes QP and VPs and other GMP methods. May draft QP or VP under direct supervision of supervisor or technical lead.
* Drafts test methods/RPs/SOPs with little guidance of supervisor or technical lead. Drafts client protocols under supervision, as needed.
* Participates in assay transfers to Operations. May serve as a trainer.
* Conduct LIMS transactions as appropriate for laboratory technician level.
* General lab housekeeping (including appropriate documentation) and ordering, inventory management, initiate work orders.
* Execute IQOQ and author equipment SOP, as needed.
* Responsible for REES/ELPRO monitoring and response.
* Prepares and maintains reagents for laboratory use.
* May be required to work holidays, weekends and overtime as needed
* May be required to assist in other departments
* Bachelors' degree in Biological Sciences or other science related field
* Experience with qPCR/molecular biology is required
* Experience with biologics, cell culture, and/or ELISA methods is desirable ddPCR experience is desirable
* Experience in a cGMP environment is highly desirable.
* Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.
* Ability to record data accurately and legibly.
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.