Gaithersburg, MD
Contract Duration: 8-36 months
Rate: Negotiable
Responsibilities:
- Excellent employment opportunity for a Research Associate in the Gaithersburg, MD area. Onsite (lab/office based)
- Position is a hands-on, laboratory-based role.
- Develop and characterize downstream processes for the manufacture of Biopharmaceuticals (monoclonal antibodies and other proteins) in late-stage clinical development through commercial launch.
- Be responsible for a portion of a purification development project.
- Make observations, analyze data and interpret results.
- Maintain accurate records of experimental results, review, analysis, and interpretation of experimental data.
- Make periodic presentations in group meetings, project team meetings, and in one-on-one situations.
- Prepare/review development reports, tech transfer and process validation documents, regulatory submissions.
- Support technology transfer to Clinical/Commercial Manufacturing facilities.
Experience:
- R&D Associate I requires a Bachelor's Degree with 0-2 years of relevant industrial experience.
- R&D Associate II requires a Bachelor's Degree with 2-5 years or a Master's Degree with 0-2 years of relevant industrial experience.
- Bachelor's or Master's Degree in Biochemistry, Chemical Engineering, or related field.
- Proficiency in protein purification principles and methods including (but not limited to) different modes of chromatography, viral removal/inactivation steps and filtration.
- Knowledge of:
- Microsoft Office
- Basic protein chemistry; protein and analytical chemistry, process robustness concepts and process scale-up
- Working knowledge of good laboratory practices
- Purification process design
- Basic analytical techniques for protein products (HPLC analysis, protein quantification methods, electrophoresis; etc.)
- AKTA systems/software
- Capable of significant multitasking with excellent oral and written communication skills.
- Experience considered a plus:
- Statistical design of experiments (DOE)
- Process scale-up and technology transfer
- cGMP manufacturing principles and environments
- Process validation
- Familiarity with risk assessments and Regulatory submissions (especially BLA)
- Purification of protein-based therapeutics other than antibodies (e.g., conjugates, bispecifics, fusion proteins or products produced by microbial systems)