Senior Research Associate, Analytical Development Job Description Template
Our company is looking for a Senior Research Associate, Analytical Development to join our team.
Responsibilities:
- May be required to assist in other departments;
- Work within matrix teams to deliver on program objectives;
- Execute IQOQ and author equipment SOP, as needed;
- General lab housekeeping (including appropriate documentation) and ordering, inventory management, initiate work orders;
- May be required to work holidays, weekends and overtime as needed;
- Author reports and source documentation to support regulatory filings;
- 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;
- Executes R&D studies planned with supervisor or technical lead;
- Evaluate new technologies for viral vector and cell therapy product characterization;
- Maintain critical reagents necessary for analytical development such as reporter cell lines, virus and recombinant proteins;
- Evaluate new technologies for viral vector and cell therapy product characterization;
- Maintain critical reagents necessary for analytical development such as reporter cell lines, virus and recombinant proteins;
- Work closely with a team of scientists in the analytical development group to design and execute method development studies.
Requirements:
- Experience with biologics, qPCR, and/or ELISA methods;
- Experience in a cGMP environment is highly desirable;
- Experience with gene therapy vectors and/or gene mediated cell therapy 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;
- Experienced with cell culture, primary human cells, and cryopreservation;
- Understanding of Design of Experiments approach to method optimization and use of software such as JMP, Minitab, or Design Expert;
- Work effectively in a collaborative team setting;
- Passionate about working at the bench to independently troubleshoot experiments and contribute to research directions;
- Experience with MS Office suite of software;
- Ability to work in a rapidly changing environment with frequent changes in priorities;
- Good understanding of compliance and cGMP considerations;
- automation experience;
- Experienced with authoring and revising test methods, protocols, and technical reports;
- Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.