Scientist I, Process Validation

Posted 22 Nov 2022

Carlsbad, California - United States

Req Id 258396

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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

 

Pay Range for this Position- $49,500 - $148,900

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.  Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.



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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

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

Apply Now