Job Description
As a member of the Process Development, CMC group, the Scientist will contri
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Essential Functions and Responsibilities:
- Design and perform experiments to identify and establish operating and performance parameters for purification steps and overall processes.
- Execute lab-scale process development and material generation activities to support pre-clinical studies and technical transfer to CDMOs.
- Perform experiments and interpret results to evaluate process parameters for individual unit operations.
- Prepare SOPs and technical reports and maintain appropriate records of experiments.
- Responsible for operation and preventive maintenance of laboratory equipment.
- Work under general supervision to ensure timely execution of projects.
- Analyze and communicate experimental results to colleagues and supervisor and provide solutions to problems.
- Collaborate across functional areas, maintaining a good rapport.
- Assist with protein inventory management.
- Other duties as deemed necessary.
Required Skills and Qualifications
- A Bachelor’s Degree and 6 to 8 years of directly relevant industry experience, a Master’s Degree with 4 to 6 years of directly relevant industry experience, or a PhD with 1 to 2 years of directly relevant industry experience is required. A BSc, MSc or PhD in Cell and Molecular Biology, Biochemistry, or a related discipline is preferred.
- Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design is required.
- The ideal candidate will have experience in the following:
- AKTA Chromatography and filtration unit operations
- Large molecule/biologic drug development
- Authoring of SOP’s and technical reports
- Working knowledge of different modes of chromatography, types of resins, and column packing.
- Strong analytical skills with hands-on experience with SDS-PAGE, HPLC, Octet, and TFF/UFDF is strongly preferred.
- Familiarity with cGMP bioprocessing and experience working with CDMO’s is preferred.
- Ability to multi-task, prioritize projects, and troubleshoot process and equipment problems.
- Ability to work in a highly collaborative environment with rapidly evolving priorities.
- Excellent written and oral communication skills.