Associate Director - Downstream Process Development
- Frederick, MD
This Maryland Biotech company is growing on the success of their proprietary platform technology and seeking highly motivated scientific and engineering professionals to join their growing company.
As the Associate Director - Downstream PD Engineer you will support the development and validation of various biologics cell culture processes from the laboratory through Phase I cGMP manufacturing scale, as well as serve project management roles and participate on various presentations. You will be the technical lead for the Downstream PD group and responsible for advising on the strategy and direction of all projects.
- Relevant skills include chromatography 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.
- Strong knowledge of 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.
- 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.
- Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments independently, and maintain up-to-date laboratory notebooks are a must.
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.
- MUST have a Bachelor or higher degree in Bio or Chemical Engineering
- protein purification and analysis (8-12 years)
- Excellent time management and proven ability to complete projects on time
- Excellent level of initiative and quest for knowledge
- Must be organized and self motivated
- Must have excellent communication and writing skills
- Familiarity with Microsoft Office (Word, Excel and Powerpoint etc.)
- Must love to learn!
Thursday, February 8, 2018
Based on expereince