We are currently seeking qualified candidates for an Analytical Manager position with the Biologics Process Development segment of a leading multinational life sciences company. This is a permanent position that will be based out of Boston, Massachusetts, United States.
The Analytical Manager will execute projects including developing, validating and transferring analytical and chromatographic methods for biotech molecules. The successful applicant will manage 2 – 4 analytical scientists and associate scientist to ensure smooth execution of client projects according to budget and timelines given to the project team. The Analytical Manager will develop, validate and transfer robust analytical methods required for successful drug development and manufacturing. The Analytical Manager will support follow-up and troubleshooting on analytical methods as well as supporting process, pharmaceutical development and pre-formulation studies with chromatographic methods, technical expertise and solutions.
- Manage 2 – 4 analytical scientist and associate scientist in planning, review of data and biologic analysis including protein chemistry, chromatographic, electrophoretic, spectroscopic and mass spectrometry techniques.
- Excellent knowledge of analytical development of chromatographic methods, validation, tech transfer and applied statistics.
- Responsible for biophysical characterization of proteins.
- Perform analyses including but not limited to CE-SDS, SE-HPLC, cIEF, LAL, host cell-DNA (qPCR), host cell protein, immunoassay and other biophysical/biochemical methods.
- To develop, validate and tech transfer robust analytical methods required for successful drug development and manufacturing.
- Knowledge of common and specific software in use in analytical labs.
- Background on chromatographic techniques applied to Biomolecules.
- Good knowledge on biotech processes development, protein purification and formulation is nice to have.
- Execute routine protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software).
- To support follow-up and troubleshooting on analytical methods.
EDUCATION, SKILLS & EXPERIENCE
- PhD in biotechnology or equivalent with 5+ years in the biopharmaceutical industry, including managerial experience.
- Solid and proven theoretical basis and hands-on experience in protein characterization.
- Proven track record in biochemical characterization of proteins including analytical and biophysical techniques. Experience with protein formulation strategies is highly desirable.
- Solid and proven working knowledge of DOE. Ability to critically analyze data using statistical tools and to compile technical reports.
- Experienced in protein purification via affinity, hydrophobic interaction (HIC), ion exchange (IEX), size exclusion (SEC) and mixed-mode chromatography.
- Excellent presentation and communication skills
- Results-oriented with ability to work and deliver under pressure