Major Duties and Responsibilities: Responsible for planning and executing purification process development and optimization for complex biopharmaceutical drugs such as bi-specific antibodies, fusion proteins, and proteins expressed in E.coli that require re-folding. Candidate is expected to participate in solving challenging protein purification problems such as aggregate removal, protein self association, and glycoform separation. Provides technical expertise in process scale-up and technology transfer to cGMP clinical and commercial manufacturing. Coordinates closely with the analytical biotechnology group and other research and development groups in order to meet project timelines and company goals. Additional job expectations include analyzing and interpreting analytical and process data, understanding process operations and contributing to appropriate experimental plans. The candidate should maintain accurate records of data and actively participate in laboratory organization. The individual should professionally deliver experimental plans and results, possess excellent writing and communication skills, and show attention to detail to support the preparation and review of development reports and presentations.
Job complexity: The job is fairly complex, requiring an understanding of the biological and chemical properties of recombinant proteins, process design, and data analyses.
Supervision: A high level of independence is required for this position.
Experience: 0 to 7 years depending on education and relevant work experience.
B.S./B.A. or M.S./M.A in biochemistry, chemical/biochemical engineering, or related field.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes
Practical experience in biotherapeutic purification process development and scale up desirable but not required.
Experience developing protein purification processes for non-Mab molecules such as bispecific antibodies, fusion proteins, and PEGylated proteins desirable but not required.
Experience solving challenging protein purification problems such as aggregate removal, protein self association, and glycoform separation desirable but not required.
Ability to troubleshoot and collaboratively resolve complex problems under tight time constraints.
Expertise in protein chromatography and tangential flow filtration desirable but not required.
Expertise with the AKTA platform and Unicorn software desirable but not required.
Good oral and written communication skills.
GMP experience desirable but not required.
Familiarity with tech transfer to pilot and commercial manufacturing desirable but not required.
Team player and customer focused.
Req ID 10204 Position Category Development - Process Biochemistry
- See more at: http://www.hirelifescience.com/r-d-associate-i-ii-purification-process-sciences/gaithersburg-md-11111-579564/?p=p&submission=2