Sr. Manufacturing Specialist (Bioprocess)

Posted 02 Dec 2022

Carlsbad, California - United States

Req Id 259093

 

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:

 

The Manufacturing Senior Specialist position in Carlsbad, CA is responsible for leading the preparation and the execution of the manufacture of a cGMP pharmaceutical product for client projects.  This position may/may not have direct supervisory responsibility for employees, but does have overall responsibility for the Projects they are assigned to. The Senior Specialist will be responsible for developing custom Master Batch Records, communicating with internal and external clients, and leading cGMP manufacturing operations.  Senior Specialists will need to follow strict compliance to cGMP manufacturing and quality policies, ensure their team is properly prepared and trained, and demonstrate good documentation practices in accordance with cGMP standards.  Senior Specialists will operate in a manner that promotes the safety and well-being of both the employees performing the work, as well as the Product being manufactured.

 

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry, Biochemistry, Biology or other life science field
  • 6+ years of experience using cGMP/GDP concepts and working in cleanroom environment performing aseptic manufacturing operations
  • 6+ years of experience with sterile cell culture and aseptic operations in a BSC/LFH (biosafety cabinet, laminar flow hood)
  • 4+ years of experience troubleshooting equipment and process failures
  • 2+ years of leadership experience while executing cGMP documentation and providing technical training to junior employees
  • 2+ years of experience drafting and revising cGMP procedures and Master Batch Records
  • 2+ years of experience communicating and guiding internal and external customers

 

OR

  • High School Diploma or GED
  • 10+ years of experience using cGMP/GDP concepts and working in cleanroom environment performing aseptic manufacturing operations
  • 10+ years of experience with sterile cell culture and aseptic operations in a BSC/LFH (biosafety cabinet, laminar flow hood)
  • 4+ years of experience troubleshooting equipment and process failures
  • 2+ years of leadership experience while executing cGMP documentation and providing technical training to junior employees
  • 2+ years of experience drafting and revising cGMP procedures and Master Batch Records
  • 2+ years’ experience communicating and guiding internal and external customers

 

Preferred Qualifications:

  • Experience with Project Planning and Scheduling
  • Experience with CellStack Culture Chambers for adherent cell culture
  • Experience with Disposable bioreactors (25 to 100L, Wave, SUB), viral vector manufacturing
  • Experience with Bulk Drug Formulation and Dilution
  • Experience Tangential flow filtration (UF/DF) with hollow fiber membranes
  • Experience with sterile fill filtration of media, buffers, and drug products
  • Experience with GE AKTA Purification Skid operation/column chromatography/column packing

 

 

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


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