Senior Manufacturing Specialist (Fill)

Posté 11 mai 2022

Carlsbad, California - United States

Demander un identifiant 248072

Détails

 

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 Fill/Finish Manufacturing Senior Specialist is responsible for leading the preparation and the execution of the manufacture of a cGMP pharmaceutical product for client projects. This is a leadership role and does not have direct reports, though is responsible for guiding a team and for overall responsibility of the Projects they are assigned to.

The Fill/Finish Manufacturing Senior Specialist guides the process and leads 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 Biological Safety Cabinet and/or inside a Grade A isolator with an automated filling machine, document review, and documentation of any events. 

 

  • Develop custom Master Batch Records, SOPs, communicate with internal and external clients, and leading cGMP manufacturing operations.
  • Maintain compliance to cGMP manufacturing and quality policies, ensure the team is properly prepared and trained, and demonstrate good documentation practices in accordance with cGMP standards.
  • Promote 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 cleanroom environment performing aseptic manufacturing operations
  • 4+ years’ experience understanding of cGMP/GDP concepts 
  • 4+ years’ experience drug product formulation 
  • 4+ years’ experience troubleshooting equipment and process failures 
  • 2+ years’ leadership experience while executing cGMP documentation and providing technical training to junior employees 
  • 2+ years’ experience with technical writing, drafting and revising cGMP procedures and Master Batch Records 
  • 2+ years’ experience communicating with internal and external customers 

 

OR

 

  • High School Diploma or GED
  • 8+ years’ work experience in a cGMP cleanroom environment performing aseptic manufacturing operations
  • 4+ years’ experience understanding of cGMP/GDP concepts 
  • 4+ years’ experience drug product formulation 
  • 4+ years’ experience troubleshooting equipment and process failures 
  • 2+ years’ leadership experience while executing cGMP documentation and providing technical
  • 2+ years’ experience with technical writing, drafting and revising cGMP procedures and Master Batch Records 
  • 2+ years’ experience communicating with internal and external customers 

 

 

 Preferred Qualifications: 

 

  • Experience with filling vials with an automated filling machine inside an isolator
  • Experience with filling vials with a dispensing pump 
  • Experience with drug substance production (upstream/downstream operations)
  • Experience writing events/deviations
  • 4+ years’ experience working knowledge of desktop computers and technical equipment (MS Office) 
  • 2+ years’ experience working with multi-department functional teams 
  • training to junior employees 
  • 2+ years’ experience working with multi-department functional teams 

 

 


 

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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