US-CA-Hayward: Assoc Research Scientist

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Date: 12-Feb-2008

Assoc Research Scientist

Job Description

The successful candidate will be responsible for:

1. Developing small-scale purification processes for therapeutic antibodies and proteins;

2. Lead junior members in the purification group to develop various purification processes;

3. Executing studies on the manufacturability, scalability, and robustness of purification process; Design and conduct studies to identify critical scale-up process parameters for purification;

4. Transferring purification processes to cGMP manufacturing, providing training to manufacturing personnel on new processes;

5. Communicating with downstream manufacturing department, conducting investigation and data analyses, trouble-shooting manufacturing purification processes;

6. Communicating with analytical group, performing essential protein assays such as protein concentration determination, SDS-PAGE, size exclusion HPLC to analyze in-process products during purification process development;

7. Maintaining & documenting detailed purification development methods, results;

8. Writing, reviewing, revising, and/or approving purification protocols, purification transfer documents, technical reports; Oral and written presentations & communications to internal manufacturing department or external scientific community.

Job Requirements

1. The successful candidates must have Bachelor's degree in a biological science field with at least 10 years working experience in biotechnology cGMP working environment, or Master’s degree with at least five years industrial experience (Ph.D preferred); have extensive knowledge, expertise and experience in therapeutic antibody or protein purification process development, scale-up and optimization; be very familiar with FDA guidance and requirements for developing a successful therapeutic antibody/protein purification process; be familiar with viral clearance study design and execution.

2. The candidate must be familiar with AKTA purification platform, have extensive experience and expertise in using a variety of chromatography methods/resins to develop purification processes, be very familiar with purification equipment (columns, filters, etc.), software and vendors, be very familiar with various filtration-related processes and products on the market, be very familiar with basic protein characterization methods (protein assays, SDS-PAGE, western blot, HPLC, etc).

3. Candidates must have the ability to work independently, have leadership experience in managing purification projects, have strong trouble-shooting and problem-solving skills, and be able to work well with multi-cross-functional work teams in a fast-pace environment. Excellent written and verbal communication skills are required.

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/