Sr. Manufacturing Specialist (Bioprocessing)

Posted 17 Jun 2022

Carlsbad, California - United States

Req Id 251153

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.


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 are expected to uphold 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 of Science degree
  • 4+ years of experience in a cGMP clean room environment performing aseptic manufacturing operations
  • 4+ years’ experience understanding cGMP/GDP concepts
  • 4+ years of experience with sterile cell culture and aseptic operations in a BSC/LFH (biosafety cabinet, laminar flow hood)
  • 4+ years of knowledge of biology and chemistry
  • 4+ years of experience troubleshooting equipment and process failures
  • 4+ years of experience working knowledge of desktop computers and technical equipment (MS Office)
  • 2+ years’ leadership experience while executing cGMP documentation and providing technical training to junior employees
  • 2+ years experience working with multi-department functional teams
  • 2+ years’ experience drafting and revising cGMP procedures and Master Batch Records
  • 2+ years’ experience communicating with internal and external customers

OR

  • HS Diploma or GED
  • 8+ years’ work experience in a cGMP clean room environment performing aseptic manufacturing operations.
  • 4+ years’ experience understanding cGMP/GDP concepts
  • 4+ years of experience with sterile cell culture and aseptic operations in a BSC/LFH (biosafety cabinet, laminar flow hood)
  • 4+ years of knowledge of biology and chemistry
  • 4+ years of experience troubleshooting equipment and process failures
  • 4+ years experience working knowledge of desktop computers and technical equipment (MS Office)
  • 2+ years’ leadership experience while executing cGMP documentation and providing technical training to junior employees
  • 2+ years experience working with multi-department functional teams
  • 2+ years’ experience drafting and revising cGMP procedures and Master Batch Records
  • 2+ years’ experience communicating with internal and external customers

 

Preferred Qualifications:

  • Experience with Project Planning and Scheduling
  • Experience with filtration, TFF (UF/DF), column chromatography, sterile final filtration, media and buffer preparation operations
  • Disposable bioreactors (25 to 100L, Wave, SUB), viral vector manufacturing experience
  • 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

 


 

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.


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. US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

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.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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