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Manufacturing Senior Specialist

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.

 

 

Who You Are:

Minimum Qualifications:

 

  • Bachelor of Science degree and 4+ years of experience OR HS Diploma or GED and 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 with sterile cell culture and aseptic operations in a BSC/LFH (bio safety cabinet, laminar flow hood)
  • 4+ years knowledge of biology and chemistry
  • 4+ years’ 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 highly preferred
  • Disposable bioreactors (25 to 100L, Wave, SUB), viral vector manufacturing experience preferred
  • Experience with Bulk Drug Formulation and Dilution preferred
  • Experience Tangential flow filtration (UF/DF) with hollow fiber membranes preferred
  • Experience with sterile fill filtration of media, buffers, and drug products preferred
  • Experience with GE AKTA Purification Skid operation / column chromatography / column packing preferred
     
Job Requisition ID:  195219
Location:  Carlsbad
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
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.

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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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