We are seeking highly motivated applicants with an entrepreneurial spirit for an open position in our biosimilar development and contract services programs. We are looking for qualified candidates with a bachelor or higher degree in biochemical engineering with highly relevant skills and process development/manufacturing experience.
The selected candidate will lead the development and scale-up of various biologics purification processes from the laboratory through Phase I /II cGMP manufacturing scales.
Relevant skills include chromatography-based separation of proteins (affinity, IEX, HIC, HA) and ultrafiltration/diafiltration (TFF and hollow fiber). Other techniques will include virus inactivation (low pH, detergents) and virus filtration. Analytical techniques include HPLC/U-HPLC (HILIC, RP, SEC, CEX, AEX, affinity), capillary electrophoresis (CE), SDS-PAGE, IEF, ELISA and LabChip platform (Perkin Elmer/Caliper).
Strong knowledge of protein chemistry, protein purification methods and process development/scale-up is required including integration of viral clearance in overall process design. Knowledge of Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) is also required.
Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments independently, and maintain up-to-date laboratory documentation are a must. Experience in the preparation and delivery of oral and written presentations, as well as participation in the preparation and submission of regulatory documents such as IND CMC sections, is sought.
This is an excellent opportunity to gain valuable experience with an innovative, small, young Biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential high reward environment and able to work overtime and weekends as project needs are determined.
Minimum Qualifications:
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