Sr. Specialist Manufacturing Fill - Whiptail

Posted 29 Sep 2021

Carlsbad, California - United States

Req Id 230227

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

 


 

Your Role:

The Manufacturing Senior Specialist position 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 of 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 to demonstrate good documentation practices in accordance with cGMP standards.  Senior Specialists are expected to operate in a manner that promotes the safety and well-being for both the employees performing the work, as well as the Product being manufactured.

The Fill/Finish Manufacturing Senior Specialist will guide the process and lead the manufacturing team through all phases and facets of drug product formulation, fill, visual inspection, and labeling. This will include training, scheduling, requesting materials, setup, preparation, final filtration and formulation, filling vials inside a Grade A isolator with an automated filling machine, document review, and documentation of any events. This role may also assist with any manufacturing role as needed including buffer/media prep, cell culture, downstream operations.

 

 Who You Are:

 

Basic Qualifications:

  • Bachelor of Science degree
  • 4+ years of experience in a cGMP cleanroom environment performing aseptic manufacturing operations
  • 4+ years’ experience understanding of cGMP/GDP concepts
  • 4+ years’ experience Buffer and Media formulation
  • 4+ years’ experience troubleshooting equipment and process failures
  • 2+ years’ leadership experience executing cGMP documentation and providing technical training to junior employees
  • 2+ years’ experience drafting and revising cGMP procedures

OR

  • HS Diploma or GED
  • 8+ years’ work experience in a cGMP clean room environment performing aseptic manufacturing operations
  • 4+ years’ experience understanding of cGMP/GDP concepts
  • 4+ years’ experience Buffer and Media formulation
  • 4+ years’ experience troubleshooting equipment and process failures
  • 2+ years’ leadership experience executing cGMP documentation and providing technical training to junior employees
  • 2+ years’ experience drafting and revising cGMP procedures

 

Preferred Qualifications:

  • Experience with filling vials with an automated filling machine inside an isolator
  • Experience with automated labeling
  • Experience with drug substance production (upstream/downstream operations)
  • Experience with single-use mixing and fluid transfer operations

RSRMS


 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

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.

 

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