- Expiry Date: 23 August 2021
The Associate Scientist will be working within the Biologics Development (BD) organization. The role will involve the development, qualification and transfer of analytical separation methods used for product release, stability study and process characterizations supporting early phase programs. The successful candidate should be self-motivated, have excellent communication skills, be a team player, and have strong knowledge and experience in advanced bioanalytical separation sciences including chromatographic and electrophoretic methods. Desired skills include Design of Experiment (DoE), HPLC/UPLC, LC-MS, Capillary Electrophoresis, as well as biophysical characterization and biological techniques. Knowledge and experience with protein / peptide characterization and molecular and cell biology would be a plus.
Develop, qualify, transfer and characterize bio-analytical techniques for monoclonal antibodies, recombinant proteins and Advanced Therapy Medicinal Products (ATMPs) to support product release, stability and process characterization studies under targeted timelines. Author method SOPs, development and qualification reports.
Provide training and oversight of assay performance to testing labs including CROs.
Work collaboratively across organization and sites for method readiness, transfer, performance and troubleshooting supporting early phase development projects.
Authors and reviews analytical method and validation sections in IND filing documents
Utilize statistical tools for Design of Experiment (DoE) to optimize assay conditions and evaluate assay robustness, and to analyze and trend development data.
Actively lead and work on internal initiatives for improvement of business processes.
Evaluate new technologies and lead scientific and technological innovations for process improvement.
Degree in Biochemistry, Biotechnology, Analytical Chemistry, Molecular Biology, Virology, Chemical / Biological / Biochemical Engineering or a related discipline.
MS with 0-2 years or BS with 3+ years relevant experience in Biotech or Pharmaceutical industry.
A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of CE, iCE, and HPLC/UPLC (UV/FL/CAD/MS).
Experience with protein fragmentation (CE-SDS, RPLC), charge variants (AEX/CEX/CIEF/iCIEF), N-glycans, peptide mapping and aggregation/HMW analysis (Size Exclusion Chromatography) techniques is highly desirable.
Experience with mass spectrometry and biophysical characterization is a plus
Working knowledge of design of experiments and basic statistical knowledge is desirable.
Excellent communication and interpersonal skills.
Works independently and collaborates with other groups. Deliver results in line with project and team objectives.
This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following: sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipments.
Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.).
Office work, teleconferencing, computer work, leading meetings requiring working in open office environment, working alone and working with/around others.
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ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.