Performs research & development activities and assay validations as required under direct supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Performs laboratory maintenance duties. Works closely with Testing Operations during assay transfer and validation activities.
- Executes R&D studies planned by supervisor or technical lead. Works under close supervision from supervisor or senior personnel
- Executes QP and VPs, and other GMP methods under supervision by supervisor or technical lead
- Drafts test methods/RPs/SOPs under guidance of supervisor or technical lead
- Conduct LIMS transactions as appropriate for laboratory technician level
- General lab housekeeping (including appropriate documentation) and ordering, inventory management, initiate work orders
- Responsible for REES/ELPRO monitoring and response
- Prepares and maintains reagents for laboratory use
- Ability to work in a team environment and independently as required
- 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 science related field
- 1 or more years of relevant experience
- Experience with mammalian cell culture and aseptic technique is required.
- Experience with cell-based ELISAs, cellular proliferation assays, or other cell-based assays is highly desirable.
- Experience with gene therapy vectors and/or gene mediated cell therapy is desirable.
- Knowledge of cGMP guidelines is preferred
- 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
- Ability to work under limited supervision at times and to handle problems