Scientist I, Failure Investigation

Posted 05 Mar 2022

Carlsbad, California - United States

Req Id 241992

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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


We are offering a $7,500 sign-on bonus! 

 

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 Scientist, Failure Investigation, who will be responsible for leading nonconformance and deviation investigations as a member of the Failure Investigation Team within the Technical Operations Department. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Quality, Operations, and Project Management teams to ensure successful and timely resolution of product and process troubleshooting efforts.

  • Drive investigations independently with limited oversight, in coordination with Technical Operations management and Quality
  • Define problem statements, perform impact and risk assessments, and utilize formal root cause analysis methods to determine and propose corrective actions
  • Independently analyze complex data, interpret results, and interface cross-functionally to collect troubleshooting information and form plans/solutions to mitigate technical issues
  • Demonstrate sustained technical expertise in a field of specialization (e.g. upstream, downstream, fill/finish) and communicate technical conclusions to broader audiences, both internal and external, in a diplomatic and professional manner
  • Lead projects to implement process improvements based on the outcome of investigations, and proactively identify process gaps and/or inefficiencies
  • Assist junior staff and other departments as a technical resource, demonstrate the ability to lead teams/efforts without direct authority, provide audit support, as needed, with limited guidance

 

Who You Are:  

Minimum Qualifications:

  • Bachelor’s degree in life sciences or other scientific disciplines
  • 7+ years of experience in life sciences and/or manufacturing setting
  • 3+ years of experience understanding of cGMP and Quality Systems within a regulated environment

OR

  • Master’s degree in life sciences or other scientific discipline
  • 5+ years (MS) of experience in life sciences and/or manufacturing setting
  • 3+ years of experience understanding of cGMP and Quality Systems within a regulated environment

 

Preferred Qualifications:

  • CMO experience
  • Technical experience in the life sciences/biopharmaceutical industry with a broad knowledge of principles, practices, and procedures in field of specialization
  • Expert-level experience with root cause analysis and other quality tools (Fishbone Diagrams, 5 Whys, etc.)
  • Experience managing corrective action (CAPA) projects

 

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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