Purification Process Expert-Scientist

• 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