MSAT Senior Engineer - Novel & Connected Bioprocessing
MilliporeSigma

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

The Technical and Scientific Solutions(TSS)group at MilliporeSigma provides high quality scientific and technical support toMilliporeSigmacustomers developing or manufacturing biopharmaceuticals.Withinthis framework, ourMSAT teamidentifiesthe best technologiesfor biomanufacturing process templates andensurestheirrobust operationthrough hands-on and consultativeguidance.

Learnmore aboutwhy we love our jobs-great colleagues,astrong purpose, andapositive impact on society-here:https://bit.ly/3lzrhJr

Anchored byourleadershipin themAbmarketover the past 2 decades, our focus is shifting toincludeemergingneedsinviral &gene therapy andnext-generationmAbmanufacturing (increased speed, quality, reduced footprint).Our scientists and engineers are guiding biologics developers and manufacturersin the bestuseofthedeepProcess Solutionsportfoliotowards the production and purification ofplasmidDNA,lentiviral,andadeno-associated viral vectors.Meanwhile, ourofferingsofnext-genmAbprocess technologies,systemsand software,willcontinue toexpandon theearly adoptionsalready taking place.

Your Role:

To supportthe scale-up and implementation ofthese 2 strategic fronts,we are seeking anengineerwithbroadbiomanufacturing knowledgeandexpertiseacross many unit operations,strongmotivation and vision,and a passion to help others succeed.You willleadourtechnicalcustomerengagementsto successful outcomes andultimately growthe businessin these new areas.

To be successful in this role youmustgainand applyproficiencyinthe above-mentionedfields,with a minimum of oversight.You will buildpartnerships withinternal & industrycontacts,toidentifygaps,plan andexecute studies,eitherwith customers or independently,tobridge thesegapswithourproducts.There is ample potential for industry thought leadershipand publication.

Examples ofchallenges to be addressed in thedevelopment ofscalable platform processes forVGT,e.g.AAV,include:

• REACH-compliant detergent lysis,employingsingle-use mixers
  
• Benzonase(TM) endonuclease dosing,optimization, and clearance
  

• Optimized serotype-dependentdepth filtrationtoimproveHCP, DNA clearance
  
• Serotype-specific AEX polishing protocols for empty/full capsid separation
  
• Clearanceof helper and adventitious virusthrough membrane nanofiltration
  
• Operationnear lower edge of capability ofsingle-use systems, due to low volumes
  

Examples of expertise to beconveyedtowardsnext-generationmAbmanufacturing include:

• Principlesof intensifiedbatch processes,such asintensifiedcapture or polishing.
  
• Operation & control ofadvancedunit operations, bridging the application and the system hardware/controls,such asperfusion harvest, continuous multi-column chromatography,andflow-through polishing.
  
• Definition of scale-down models for validation,e.g.viral clearance, and what constitutes a batch.
  
• Proficiencyinnew software platforms for the digital plantfacilitatingQbDand data integrity:
  

• Orchestrationplatformallows forconnectivity across unit operations for the collection of process data and/or control of other unit operations.
  

• ProcessPaddelivers advanced analytics capabilities for rapid process insights and optimization,generates digital documentation of all critical process parameters while user friendly dashboards give easy access to gathered data.
  

Minimum Qualifications:

• B.S. in Chemical Engineering or Biotechnology plus 5 years' experience inbioprocess field.
  
• M.S. in Chemical Engineering or Biotechnology plus 4 years' experience inbioprocess field
  

• PhD in Chemical Engineering or Biotechnology plus 2 years' experience inbioprocess field
  
• Minimum 2 years hands-on experience with downstream purification of biologics,plus an advancedknowledge ofunit operationprinciplesinmembrane and depth filtration, mixing,chromatography,tangential flow filtration
  
• Motivationtodevelop ourcapabilitiesin theabove-mentionedareasand others, as aligned with internal stakeholders,and deploythisas asupport offering.You thrivewithfreedom tooperate,andseektodifferentiate yourself in the industry
  
• Demonstrated ability to communicate technical concepts to colleagues and customers using excellent written and verbal communication skills.
  
• Ability to plan comprehensively and reliably track, document and communicate results.
  

Preferred Qualifications:

• Experience usingscale-down modelsfor characterization andvalidationof unit operations.
  
• Experiencewith statistical process control orstatistical data analysis in development, including design of experiments (DoE), throughdata analytics software.
  
• ExperiencerunningaManufacturing Execution System (MES) softwareand understanding the key user needs for batch execution, monitoring, and reporting.
  

• Experiencedefining process control strategies for process validation followingQbDprinciples and includingPAT.
  
• Capable of developing innovative solutions to complex problems and performing studies in any downstream technology based on self-developed protocols and best practices.
  
• Ability to lead technology and/or initiative-focused global teams.
  
• Knowledge of the large molecule quality standards and regulatory environment,and experience operating within a Quality Management System.
  

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 230028

Location: Burlington

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.