Sr. Manufacturing Specialist

Job description

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. 

 

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

 

 

 

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.

Job Requisition ID:  258201

Location:  Carlsbad

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontext1722e80f7dc3f6d2 a{ border: 1px solid transparent; } .buttontext1722e80f7dc3f6d2 a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

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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