Summary of Position:
The Associate Scientist I - Analytical Development will be responsible for providing analytical support to the department of Quality Control. This includes, but is not limited to, the following: development of new analytical methods for Quality Control, overseeing transfer of new methods from Analytical Development and Research & Development to Quality Control, and Process Development; troubleshooting issues with existing QC methods; qualification of new reference standards, controls, critical reagents and biochemical characterization testing of cGMP and developmental products manufactured by Celldex Biomanufacturing Operations. This position is located at the Fall River, MA facility.
- Under the guidance of the Analytical Development Manager, conduct various independent and team driven laboratory experiments to satisfy the overall AD objectives of development and/or troubleshooting of assays for Quality Control.
- Assist with the hands-on execution of approved experimental protocols
- Generate, and maintain supplies of critical reagents, standards, and controls in addition to conducting the associated qualifications.
- Author and / or assist in the authoring of SOPs, technical reports, qualification reports and transfer study reports based on the results of laboratory experiments.
- Assist in the ordering and receipt of reagents, equipment and labware.
- Assist with the day-to-day maintenance of an orderly analytical laboratory.
- Assist in data management and archival.
- Provide back-up support for several critical assays performed by Quality Control.
- The ability to creatively solve analytical problems.
- Ability to follow and accurately execute existing SOPs
- Strong interpersonal skills.
- Excellent self-management skills.
- Excellent written and oral communication skills.
- The ability to work independently and as part of a team.
- Occasional travel to R&D facilities.
- BS/BA degree in biological or chemical sciences or a related field.
- 1+ years experience in the Biotechnology/Pharmaceutical industry working with biotechnology derived products.
- Experience with HPLC, SDS-PAGE, ELISA, IEF, standard analytical techniques necessary. Experience with SEC-MALLS, DSC, FT-IR, and MS desired.