ASSOCIATE SCIENTIST ? PROCESS DEVELOPMENT ANALYTICS
The Associate Scientist will be responsible for supporting a variety of analytical activities within biologics process development (PD). The role will involve supporting in-process analytical testing, delivering results within customer and project timelines, operation and automation of analytical methodologies on Tecan, assay harmonization activities within the network groups, and evaluation of new analytical technologies. The successful candidate will have excellent knowledge and working experience in immunoassays, LC, CE and Electrophoretic techniques. A good understanding of upstream and downstream process development activities is highly desirable.
? Develop, transfer and evaluate bio-analytical techniques for monoclonal antibodies and recombinant proteins to support process development.
? Assay support of biologics process development activities.
? Separation techniques (LC, CE, iCE) and immunoassays (including HCP, residual Protein A and other impurities) to support biologics process development activities.
? Operate and automate routine assays on a Tecan or similar automation platforms.
? Work closely with process development to support analytical needs and engage in long-term collaboration.
? Follow written scientific methods and experimental protocols, documents results, authors and reviews summary reports.
? Run tests and trend assay performances across the network sites.
? Review PD design of experiments study protocols.
? Support manufacturing site investigations as required.
? A degree in biochemistry, biotechnology, analytical chemistry or a related discipline.
? MS with 1+ years or BS with 3+ years relevant experience in biotech or pharmaceutical industry, preferably in a fully or partially automated lab environment.
? A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of LC (UV/FL/CAD/MS) (including SEC and Titer), Caliper, CE, iCE and immunoassays (e.g. HCP, rProtein A, and Insulin ELISAs).
? Working knowledge of design of experiments and factorial design.
? Familiarity with upstream and downstream biologics processing.
? Knowledge of cGMPs as applied to process development and scale up.
? Development experience for both early and late-stage molecules is highly desired.
? Excellent communication and interpersonal skills.
? Works independently and collaborates with other groups.
? Deliver results in line with project and team objectives.
Position Handles Hazardous Materials
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Patrick: email@example.com
ALPHA'S REQUIREMENT #17-00878