Scientist II, Process Development

Posted 01 Dec 2021

Carlsbad, California - United States

Req Id 235510

Details

 

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.

 


Scientist II Process Development

 

Your role:

MilliporeSigma is seeking a highly motivated scientist In Carlsbad, CA to join 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 effectively as a Process Development team member to lead viral vector cell culture process development and support process characterization and process validation. The candidate will also act as a driver for continuous innovation and operational improvement to advance the field of viral vector science.

The candidate is expected to be:

  • Primary technical lead on development of viral vector production processes for transfer into GMP manufacturing for internal and external client projects. 
  • Able to apply sound scientific principles to independently define process development work scope, generate study protocols and reports, execute studies, analyze experimental results, and make data-driven process decisions.
  • Interfacing with both internal and external customers as technical subject matter expert to routinely provide technical guidance and updates.
  • Able to lead technical process transfers from internal and external sites.
  • Collaborating cross-functionally with the Tech Transfer and Manufacturing teams to facilitate the transfer of processes into GMP Manufacturing.
  • Providing support to process characterization and process validation activities.
  • Able to communicate effectively with Technical Operations Leadership team, internal and external network partners, and the Product Teams.
  • Applying Quality by Design (QbD) principles and incorporating statistical design of experiment (DoE) approach in the process development work.
  • Routinely promoting a culture of continuous improvement within the Process Development group and championing initiatives to improve client service.
  • Lead by example and offer scientific coaching and mentoring to other staff members.

 

Who you are:

Minimum Qualifications:

  •  Bachelor’s Degree in biology, biochemistry, chemistry, chemical engineering, or related life science studies.
  • 10+ years, MS with 7+ years or a PhD with 3+ years of experience in pharma, medical device, biologics, or similar technical industries.
  • 3+ years of hands-on experience in suspension cell culture process development operation.

 

Preferred Qualifications:

  • Experience with cell culture process development for biologics production at bench-scale and pilot-scale using mammalian expression and single-use bioreactor systems.
  • Knowledge of downstream purification operations (clarification, tangential flow filtration, and chromatography) is desirable.
  • Familiarity with analytical assay methods (qPCR, ddPCR, ELISA, HPLC, SDS PAGE) is a plus.
  • Ability to apply expert technical knowledge to complete complex assignments.
  • Experience with DoE using JMP or similar software for experimental design and analysis.
  • Experience with cGMP manufacturing and quality systems within an FDA regulated environment.
  • Experience with managing and mentoring junior employees.

 

 


 

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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