Scientist I, Process Validation

Posted 22 Nov 2022

Carlsbad, California - United States

Req Id 258396

 

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 for those that qualify! 

 

Your Role:

MilliporeSigma is seeking a motivated Scientist I, Process Validation to join its dynamic and collaborative Process Validation team at the Carlsbad viral vector CDMO facility. The successful candidate will play a key role in supporting client process commercialization activities. The candidate will also act as a driver for continuous advancement in viral vector process validation and operational excellence across functions.

 

The candidate will perform the following in this role:

  • Act as technical SME for processes in Process Qualification and Commercial Manufacturing stages
  • Participate in process commercialization/product development stage gate reviews
  • Work cross-functionally with the Manufacturing, Process Development, Engineering, and Quality teams as well as external clients to assess process risks and identify critical process parameters
  • Support intake or development of process design documentation and work with cross-functional teams to ensure appropriate translation into production records
  • Act as owner of Process Validation-related documentation, including Process Performance Qualification and aseptic processing simulation protocols and reports
  • Apply sound scientific principles to define scope of work, generate protocols and reports, analyze results, and make data-driven decisions
  • Communicate with the technical leadership team, internal and external stakeholders, and the product management teams
  • Apply Quality by Design (QbD) principles to process commercialization activities
  • Maintain technical leadership through continuous learning 
  • Routinely promoting a culture of continuous improvement within the Process Validation team and championing initiatives to improve client service
  • Leading by example and offering scientific coaching and mentoring to junior staff members

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other life science field
  • 7+ years of experience in pharma, medical device, biologics, or similar technical industries 
  • 6+ months of experience working in a cGMP manufacturing and quality systems within an FDA-regulated environment
  • 6+ months of Process Development or manufacturing experience within an FDA-regulated environment

 

OR

 

  • Master’s Degree in Chemistry, Biochemistry, Biology, or other life science field
  • 5+ years of experience in pharma, medical device, biologics, or similar technical industries
  • 6+ months of experience working in a cGMP manufacturing and quality systems within an FDA-regulated environment
  • 6+ months of Process Development or manufacturing experience within an FDA-regulated environment

 

OR

 

  • Ph.D. Degree in Chemistry, Biochemistry, Biology, or other life science field
  • 6+ months of experience in pharma, medical device, biologics, or similar technical industries
  • 6+ months of experience working in a cGMP manufacturing and quality systems within an FDA-regulated environment
  • 6+ months of Process Development or manufacturing experience within an FDA-regulated environment

 

 

Preferred Qualifications:

  • Familiar with biologics commercialization, Quality by Design, and risk management tools
  • Ability to apply expert technical knowledge to complete complex projects
  • Effective communicator of scientific and technical ideas; strong written and verbal communication skills
  • Excellent organization skills and ability to prioritize multiple projects and tasks to meet timelines
  • Large-molecule and/or CDMO work experience

 


 

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!

 

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 Colorado or New York City, 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.


Careers during Covid-19

Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. 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.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. 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.

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