GMP Technical Writer

Posted 08 Jun 2022

St. Louis, Missouri - United States

Req Id 250259

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.


Your Role

At MilliporeSigma, the GMP Technical Writer is responsible for the creation and revision of batch records for use in the GMP manufacturing of new custom products.  This technically sound position works cross-functionally at multiple manufacturing facilities with Manufacturing, Process and Analytical Development, Quality, Project Management, and customers to develop robust manufacturing batch records from tech transfer documents.  We are looking for a candidate with strong composition skills, comprehensive technical knowledge, and understanding of manufacturing equipment and production processes.  This position reports through the Technical Operations- Product Integration group at the Cherokee, St. Louis, Missouri site.

 

  • Primary role of this position is to author batch records in support of new and scaled processes supporting the Antibody Drug Substance and Bioconjugate contract drug manufacturing operations at the Cherokee site.
  • Stay current with manufacturing best practices
  • Maintain site templates and operating procedures for batch record creation
  • Support tech transfer and process monitoring as needed.
  • Focus on client success and transparency with each program
  • Communicate effectively and timely to address internal and client comments ensuring the document content meets the intention and required details to be successful.
  • Participate as a key member of the project team to complete deliverables On Time and in Full.

 

Who You Are:


Minimum Qualifications:

 

  • Associate degree in applicable field
    • 4+ years’ technical competency and experience in biopharmaceutical GMP manufacturing
  • Bachelor’s Degree in chemistry, Biochemistry, Chemical Engineering, Biology, or related life science discipline.
    • 0+ years’ technical competency and experience in GMP manufacturing


Preferred Qualifications
 

  • Proven prior experience in a technical writer position specifically in the GMP/Biotech/Pharma/Regulated Industry.
  • Demonstrated experience in detailed review work and following procedures, especially in a GMP regulated industry.
  • Previous experience operating equipment such as single-use reactors, TFF skids, chromatography skids, and reactor systems.
  • Independent, self-starter with proven results in biopharmaceutical manufacturing operations.
  • Demonstrated ability to work effectively cross-functionally.
  • Very strong attention to detail
  • Excellent oral and written communication skills.
  • Good evaluation and analytic skills for problem identification and communication to others.
  • Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, and Outlook, as well as familiarity working in a windows-based environment.


 


 

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 NYC, 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.

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