Scientist II, Process Development

Posté 29 déc. 2021

Carlsbad, California - United States

Demander un identifiant 235817

Détails

 

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.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 


Your Role:

MilliporeSigma is seeking a highly motivated and creative individual to be a part of a cutting-edge gene therapy process development team. As part of a dynamic organization and global leader in life sciences, the successful candidate will work as a Process Development team member to develop viral vector processes, execute process characterization studies, support process validation, analytical development, and execute analytical testing. You will also provide input for areas of innovation, new product development, and technical representation to advance the field of viral therapy.

 

  • Primary technical lead for the development of internal and external viral vector processes for transfer into cGMP manufacturing.  
  • Responsible for understanding the scope of work, generating study protocols and reports, executing studies, developing and executing analytical assays, analyzing results.
  • Interface with clients prior to initiating programs to provide technical guidance, as well as throughout the project to provide updates and troubleshooting when needed.
  • Support technical process transfers internally and from 3rd party sites.
  • Work cross-functionally with the Tech Transfer and Manufacturing teams to facilitate the transfer of the processes from Process Development into GMP Manufacturing.
  • Support Process Characterization and Process Validation studies.
  • Communicate effectively with Technical Operations Leadership team, internal and external network partners and the Product Teams.
  • Executing Quality by Design (QbD) principles and incorporating statistical design of experiment (DoE) approach in the process development work.

 

Who you are:

Minimum Qualifications:

  • Degree in Biology, Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field
  • BS with 10+ years, MS with 7+ years or a PhD with 3+ years of experience
  • 3+ years hands-on experience in Upstream OR Downstream Bioprocessing unit operations and development of analytical assays
  • Experience with column chromatography and bioreactor development

Preferred Qualifications:

  • Experience with viral vector production at the research and pilot scale, mammalian cell culture processes (adherent and in bioreactors), and single-use systems
  • Analytical assay experience (qPCR, ddPCR, ELISA, HPLC, SDS PAGE)
  • Experience with downstream unit operations (clarification, tangential flow filtration, and chromatography)
  • Ability to exercise significant judgment when analyzing complex projects and demonstrate a high level of scientific achievement and understanding
  • Experience with DOE using JMP or similar software for experimental design and analysis
  • Innovative approach to problem-solving and integrated view of business/scientific issues
  • Promote a culture of continuous improvement within Process Development; act as champion on initiatives and/or projects to drive improvement in client service
  • Lead by example, offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects)
  • Experience with cGMP manufacturing and Quality Systems within an FDA regulated environment a plus.

 

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!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

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

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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.

 

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