Sr. Scientist, Tech Transfer

Posted 24 Feb 2022

Carlsbad, California - United States

Req Id 241555

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.


 

We are offering a $7,500 sign-on bonus for those that qualify!

 

Your Role:

 

The Carlsbad Gene Therapy Viral Vector Manufacturing facility is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Sr. Scientist, Tech Transfer who will be responsible for supporting process transfer from Development to cGMP Manufacturing as a member of the Tech Transfer team within Technical Operations. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Process Development, and Project Management teams to ensure successful and timely process transfer and scale-up for critical client-facing projects.

 

  • Lead projects to transfer internal and client-facing processes from development to manufacturing by collaborating cross-functionally with both internal and external stakeholders
  • Generate documentation (item specifications, batch records, SOPs, bills of material, production summaries, etc.) based on inputs from the development team and requirements/constraints provided by the manufacturing, quality, and operations teams
  • Support the execution of engineering/pilot runs for viral production, purification, formulation, and filling processes, and train manufacturing staff as needed
  • Source materials internally/externally for the completion of full-scale pilot runs and define final material and labor requirements for manufacturing
  • Apply working knowledge of FDA and EMA guidance to procedures and processes
  • Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions

 

Who You Are:

Minimum Qualifications:

  • Master’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 5+ years of experience in process development, engineering, and/or manufacturing experience
  • 5+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment
  • 5+ years direct experience with upstream manufacturing for large molecule biopharmaceutical production, with emphasis on large-scale single-use bioreactor systems

Or

  • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science field
  • 10+ years of process development, engineering, and/or manufacturing experience
  • 5+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment
  • 5+ years direct experience with upstream manufacturing for large molecule biopharmaceutical production, with emphasis on large-scale single-use bioreactor systems

 

 

Preferred Qualifications 

  • PhD in a Life Science field
  • CMO experience
  • Subject matter expertise in large-scale upstream bioprocessing
  • Strong statistical analysis (JMP) skillset and familiarity with the design of experiments (DOE) studies
  • Solid track record of identifying and proposing solutions to improve the scalability and efficiency of both manufacturing and documentation processes
  • Familiarity with cGMP document control systems and general procedures
  • Excellent attention to detail, with superior documentation and organization skills
  • Excellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience

RSRMS


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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.

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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