Manufacturing Assistant Jobs in San Rafael, CA (NOW HIRING)

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.

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 w/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.

Design & develop downstream process, scale-up, & DOE studies.

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 includes but 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

B.Sc./M.Sc./Ph.D. in Chemical Engineering/ Biochemical Engineering or Life Sciences, Chemistry/Biochemistry or related discipline

2 years experiences with a Ph.D. or 5 years experiences with a B.Sc./M.Sc. in a Purification Process Development in the biotechnology or diagnostics industry.

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960