Location – Cranbury, NJ
SUMMARY OF POSITION
TheSeniorResearchInvestigatorIIposition will havedemonstrated experience evaluatingand managing contract research organizations (CROs)to support therapeutic protein methods development/validation, characterization, lot release and stabilitytesting. Thesuccessful candidatewill also be responsibleforknowledgedevelopment to facilitate fundamental product andprocess understanding, and the advancement ofinnovative approaches to thesupport ofdrugdevelopment. Support fordrugcandidates across all stages ofdevelopmentand, as needed,within our commercial product portfolio will be required
Thesuccessful candidatewill beahighlymotivated individual readyto work within a science-focused, collaborative, multidisciplinarydrugsubstanceand drugproduct development environment.
MAJOR ACTIVITIESAND RESPONSIBILITIES
Reportingto theDirector, Pharmaceutical Development, theSeniorResearchInvestigator
- Managethedevelopment, optimization and validation of analytical methods.
- Designexperiments forthe characterization ofprotein therapeutics.
- Designand lead thesuccessful execution of experiments for comparability assessments.
- Designexperiments forthequalification/validation of analytical methods and theirtransferto qualitycontrol and contract laboratories.
- Support therapeuticprotein drugsubstanceprocess development and validation.
- Support therapeuticprotein drugproduct formulation, evaluation ofprototypes, process development andvalidation.
- Serveon and lead departmental, interdepartmental and project teams.
- Write formal reports forinclusion in regulatoryfilings and support thegeneration of appropriate responsesto questions from regulatoryauthorities.
- Adhereto all relevantcompliance requirements.
Reports to theDirector,Pharmaceutical Development.
QUALIFICATIONSAND BACKGROUND REQUIREMENTS Educational Requirements
- BSin Analytical Chemistry,Biochemistry(or relevant discipline) and minimum of10years ofpharmaceutical laboratoryexperience required; or
- MSin Analytical Chemistry,Biochemistry(or relevant discipline) and minimum of8years ofpharmaceutical laboratoryexperiencerequired; or
- Ph.D. in Analytical Chemistry, Biochemistry(orrelevant discipline)and minimum of5years ofpharmaceutical laboratoryexperiencerequired
- Comprehensivehands-onknowledgeofprotein analytics andcharacterization.
- A demonstrated record ofscientificaccomplishment, laboratoryexperimentation, publication and presentation.
- Extensivelaboratoryexperiencewith and an in-depth knowledgeof analytical methods and biophysical characterization techniques such as HPLC(RP, SEC, IEC), CE, MS, AUC, CD, DSC, PeptideMapping,PeptideSequencing, Oligo/MonosaccharideAnalysis and Spectroscopy.
- Extensivelaboratoryexperiencewith and an in-depth knowledgeofbioanalytical techniques such as SDS-PAGE, DIGE, WesternBlot, CE-SDS, ELISA, qPCR, Cell-based bioassays,BIAcore,cIEF, etc.
- Demonstrated experiencewith therapeuticprotein characterization for registrational filings(BLA/MAA).
- Strongproblem-solvingand troubleshootingskills.
- Strongcapabilities in experimental design andexecution and datainterpretation.
- Abilityto work independently.
- Abilityto providescientificguidance, leadership and trainingto others within/outsidethedepartment.
- Strongverbal and written communication skills.
- Stronginterpersonal skills.
- In-depth knowledgeofcGLP/ cGMP, FDA, EMA andICHguidance’s and industrystandards fortherapeuticprotein development, analyticsand characterization.
- Familiaritywith theUSPand other compendia.
Skills/Knowledgeinoneormoreofthefollowing areas is a plus:
- Advanced skills in statistics and statistical analysis ofdata.
- Advanced skills in DOE,QbD.