Analytical Biochemist Associate II

Biophase Solutions specializes in placing the top talented professionals in the leading Biotech and Pharamceutical companies in Los Angeles and Orange County.  We are currently recruiting for an Analytical Biochemist Associate II.



Position Title:  Analytical Biochemistry Associate II

The Analytical Biochemistry Associate II is responsible for leading research, development and optimization (including trouble-shooting) of new and existing biochemical methods for characterization of recombinant proteins for human therapeutic use.  The individual will take a product through the method development process and eventual transfer to a quality control department in a cGMP environment.  Technically-based writing skills are required for generating development and final reports and associated cGMP documentation. The individual will assist in training and supporting less experienced associates and analysts. In addition, this position requires any needed assay support and testing for the Process Development group.

 

Responsibilities

 Perform research and development of new and existing methods for characterization of recombinant proteins with aptitude and minimal supervision. 

 Ability to design and execute developmental activities.  Use of technical proficiency, theoretical understanding, scientific creativity, independent thought and collaboration with others to solve bioanalytical assay related problems.

 Exhibit time management and multitasking abilities by coordinating multiple projects and one time to meet firm deadlines.

 Exercise scientifically sound judgment within defined procedures to determine appropriate course of action with a keen sense and attention to detail.

 Draft and revise GMP documentation to be used by the analytical quality control department such as test methods, formulation methods, and SOPs.  Writing protocols and reports will also be required for validations and qualifications of methods and/or equipment.

 

·  Understanding and compliance with FDA, ICH, USP and EMEA guidelines is mandatory. Adhere to industry and government standards regarding aseptic technique and safe handling of biohazardous materials and with all safety policies, practices and procedures.

 Technical review of data, procedures and reports.

 Maintain laboratory notebooks and follow GLP and cGMP documentation requirements

 Test recombinant proteins according to established SOPs and test methods using the following instruments/techniques: UV spectrophotometer, HPLC, Capillary Electrophoresis, SDS-PAGE, FACE Glycosylation Profiling, ELISA, Endotoxin and other related methods.

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·  Identify areas for improvement and increased efficiency; assist in implementing approved changes.

 

·  Participate in proactive team efforts to achieve departmental and company goals.

 

·  Perform other duties when needed.

 

Qualifications

 

Bachelor’s degree or equivalent from a four-year college or university with two to five years related industrial experience in the fields of biochemistry, chemistry, biology, or biotechnology; or equivalent combination of education and experience. A general understanding of the theories for the above mentioned techniques is required in addition to familiarity with ICH guidelines.  Candidates MUST have experience developing and troubleshooting assays. Experience with writing SOP's and writing validation qualification reports is also necesssary.  Candidates with Protein Biochemistry and HPLC are expected.  Please do not submit your resume unless you have these qualifications.



If you are interested in applying for this position please submit your resume directly to chris@biophaseinc.com and also check our website for other clinical and scientific listings: www.biophaseinc.com