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On Call Staffing Solutions, Inc.

Purification Specialist- Manufacturing Sciences

Post Date:Feb 09, 2018Type:Contractor
Start Date:2/9/2018Salary:
Location:US-CA-Emeryville, CA Job Reference:
Skills:

Protein Purification - cGMP - Biotech -Protein Purification - cGMP - Biotech


Education: A minimum of 3 years' experience in a regulated biotechnology / medical device industry, or 8 years of relevant work experience.

Minimum Requirements:

BS in Biological Sciences, Physical Sciences, or Engineering Master's degree a plus

Required Skills: 

·         LEAN MANUFACTURING

·         SAP

·         CGMP

·         COLUMN CHROMATOGRAPHY

·         PROTEIN PURIFICATION

·         Additional Skills:

·         SOP

·         OPEX


 On Call Staffing Solutions, Inc. is an Equal Opportunity Employer – Minority/Female/Disability/Veterans



Job Description:

Protein Purification - cGMP - Biotech -Protein Purification - cGMP - Biotech


SPECIAL PROJECT -CLINICAL MANUFACTURING OF NEW RECOMBINANT THERAPEUTIC

PURIFICATION SPECIALIST

The main responsibility of the Specialist is to provide front-line technical support and act as the primary support for tech transfer activities of new processes/products into Manufacturing. This will include supporting production efforts through advanced activities such as running process equipment, trouble shooting processes, and document revision. Support process technology transfers from other departments into Manufacturing. Participate in high level department projects & initiatives designed to improve operational capabilities. Provide technical troubleshooting support in the event of an issue.

Author & revise applicable department documentation including Batch Production Documents (BPDs) & Standard Operating Procedures (SOPs). Analyze operational data & utilize statistical process monitoring tools to reduce process variability. Assist department staff with production support activities including pre-production checks & equipment testing activities as required.

Skills:

·         Must have strong technical expertise in biotech unit operations and equipment, specifically in protein purification (column chromatography, AKTA system operations, protein refolding, TFF).

·         Must have thorough knowledge and application of cGMPs including equipment &  technology

·         Established troubleshooting abilities including process monitoring

·         Strong interpersonal & cross-functional team building skills

·         Excellent communication skills, organizational skills, keen observation, writing and problem solving skills

·         Must be able to work independently, and as well as in team settings with the ability to prioritize & complete activities on time

·         Must be able to establish & maintain effective working relationships with cross-functional stakeholders & co-workers

·         Exposure to SAP and UNICORN software is a significant plus

·         5S, OpEx & Lean manufacturing experience a plus

·         Microsoft Word and Excel experience required

·         Keywords:

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Contact Information
On Call Staffing Solutions, Inc.
Name: Brian Nickel


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