Artech Information System LLC
Purification Process Expert-Scientist
Artech Information System LLC, Emeryville, California, United States, 94608
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
As a Subject Matter Expert/tech lead in recombinant protein Purification processes. Identify process or method improvements for microbially produced immune Diagnostics antigen products, support commercial manufacturing & lead technology transfers into Manufacturing. Subject Matter Expert in protein Purification process design and improvement & technical transfer to manufacturing. Liaise with Laboratory Managers & negotiate appropriate resource needs & timelines for studies. Provide supervision & mentoring to Laboratory Associates during performance of studies. Be a resource to other departments as Subject Matter Expert for product & process knowledge. Support technology transfer of scaled up processes into commercial Manufacturing. Ensure process characterization studies / technical batches generate sufficient process knowledge by thoroughly testing critical variables. Implement new process or analytical technologies into manufacturing. Assist in statistical analysis of data & identify studies to improve process capability (CpK) and/or yield & reduce cost of goods. Author scientific study protocols & reports for identified studies in their area of expertise. Lead studies to characterize Purification process parameters in the risk assessments to define their criticality & to define Proven Acceptable Ranges (PAR) for Critical Process Parameters (CPPs). Identify process improvements opportunities for commercial Manufacturing, studies include but are not limited to purification process parameters improvement, resin/membrane screening & scale down/up. Provide technical guidance for Change Controls for the implementation of downstream Purification process changes. Perform evaluations of downstream process change requests as needed. Lead or assist in investigations relating to Manufacturing or QC deviations & Out of Specifications (OOSs) & develop studies to determine their root causes. Design studies & experiments to support process/method improvement or changes & to support closure of discrepancy events or deviations. Use scientific & statistical knowledge to analyze data to provide process understanding, & to identify root causes of product & process failures. Provide front line support to manufacturing, working with the shift teams focusing on manufacturing each batch safely, on time, in compliance with the batch instructions & quality requirements. Validation support to develop & drive stage 1 requirements to support product life cycle management. Working with manufacturing support group, execution & review of protocol/report, assure consistency of master batch records, support in Deviation, Out Of Expectation, Out Of Specification, CAPAs, complaint handling. Skills: Strong knowledge of protein purification & protein chemistry techniques including: column chromatography (IEX, HIC, IMAC, SEC, RP, mix mode, affinity) & membrane chromatography, depth filtration, centrifugation, UF/DF. Analytical skills (SDS-PAGE, western blots, IEF, UV/Vis spectrophotometry, HPLC, ELISA, etc.). Extensive working knowledge of Purification process development for recombinant protein expression & purification including operational proficiency with AKTA Explorer / AKTA Pilot / AKTA Crossflow, Sci-Log TFF, large scale column packing, testing are required. Prior Project Leadership of at least 1 project of moderate scope implementing a change into Manufacturing or QC. Experience in technology transfer of processes or methods from non-GMP to GMP environments. Knowledgeable in cGMP environments & in particular of process validation strategies & requirements. Thorough knowledge of the use of statistics & design of experiments to test hypotheses. Excellent written, verbal & presentation communication skills. Local language: English. Capable of effective use of Microsoft Word, Excel & PowerPoint. Strong working knowledge of DOE approaches & programs such as JMP or Minitab for experimental design. Good knowledge of Project Management tools including prior leadership of at least 1 project with a moderately complex scope. Knowledge of business principles including the interactions needed between departments to successfully complete projects. Qualifications
B.Sc./M.Sc./Ph.D. in Chemical Engineering/ Biochemical Engineering or Life Sciences, Chemistry/Biochemistry or related discipline. ≥2 years experience with a Ph.D. or ≥5 years experience with a B.Sc./M.Sc. in Purification Process Development in the biotechnology or diagnostics industry.
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As a Subject Matter Expert/tech lead in recombinant protein Purification processes. Identify process or method improvements for microbially produced immune Diagnostics antigen products, support commercial manufacturing & lead technology transfers into Manufacturing. Subject Matter Expert in protein Purification process design and improvement & technical transfer to manufacturing. Liaise with Laboratory Managers & negotiate appropriate resource needs & timelines for studies. Provide supervision & mentoring to Laboratory Associates during performance of studies. Be a resource to other departments as Subject Matter Expert for product & process knowledge. Support technology transfer of scaled up processes into commercial Manufacturing. Ensure process characterization studies / technical batches generate sufficient process knowledge by thoroughly testing critical variables. Implement new process or analytical technologies into manufacturing. Assist in statistical analysis of data & identify studies to improve process capability (CpK) and/or yield & reduce cost of goods. Author scientific study protocols & reports for identified studies in their area of expertise. Lead studies to characterize Purification process parameters in the risk assessments to define their criticality & to define Proven Acceptable Ranges (PAR) for Critical Process Parameters (CPPs). Identify process improvements opportunities for commercial Manufacturing, studies include but are not limited to purification process parameters improvement, resin/membrane screening & scale down/up. Provide technical guidance for Change Controls for the implementation of downstream Purification process changes. Perform evaluations of downstream process change requests as needed. Lead or assist in investigations relating to Manufacturing or QC deviations & Out of Specifications (OOSs) & develop studies to determine their root causes. Design studies & experiments to support process/method improvement or changes & to support closure of discrepancy events or deviations. Use scientific & statistical knowledge to analyze data to provide process understanding, & to identify root causes of product & process failures. Provide front line support to manufacturing, working with the shift teams focusing on manufacturing each batch safely, on time, in compliance with the batch instructions & quality requirements. Validation support to develop & drive stage 1 requirements to support product life cycle management. Working with manufacturing support group, execution & review of protocol/report, assure consistency of master batch records, support in Deviation, Out Of Expectation, Out Of Specification, CAPAs, complaint handling. Skills: Strong knowledge of protein purification & protein chemistry techniques including: column chromatography (IEX, HIC, IMAC, SEC, RP, mix mode, affinity) & membrane chromatography, depth filtration, centrifugation, UF/DF. Analytical skills (SDS-PAGE, western blots, IEF, UV/Vis spectrophotometry, HPLC, ELISA, etc.). Extensive working knowledge of Purification process development for recombinant protein expression & purification including operational proficiency with AKTA Explorer / AKTA Pilot / AKTA Crossflow, Sci-Log TFF, large scale column packing, testing are required. Prior Project Leadership of at least 1 project of moderate scope implementing a change into Manufacturing or QC. Experience in technology transfer of processes or methods from non-GMP to GMP environments. Knowledgeable in cGMP environments & in particular of process validation strategies & requirements. Thorough knowledge of the use of statistics & design of experiments to test hypotheses. Excellent written, verbal & presentation communication skills. Local language: English. Capable of effective use of Microsoft Word, Excel & PowerPoint. Strong working knowledge of DOE approaches & programs such as JMP or Minitab for experimental design. Good knowledge of Project Management tools including prior leadership of at least 1 project with a moderately complex scope. Knowledge of business principles including the interactions needed between departments to successfully complete projects. Qualifications
B.Sc./M.Sc./Ph.D. in Chemical Engineering/ Biochemical Engineering or Life Sciences, Chemistry/Biochemistry or related discipline. ≥2 years experience with a Ph.D. or ≥5 years experience with a B.Sc./M.Sc. in Purification Process Development in the biotechnology or diagnostics industry.
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