Life Cycle Specialist II

Posté 21 juin 2022

Carlsbad, California - United States

Demander un identifiant 250656



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:

This position is responsible for supporting client-facing projects as a member of the Life Cycle Management team within Technical Operations. The successful candidate will work
cross-functionally with the Manufacturing, Process Development, and Quality teams to implement changes to bioprocesses in cGMP production.


Responsible for activities including:

  • Collaborate cross-functionally with both internal and external stakeholders to implement changes that enable continuous improvement, scale-up, and sustaining of existing cGMP manufacturing processes
  • Coordinate and drive change orders and related efforts to update manufacturing documentation including batch records, item specifications, forms, SOPs, and bills of material for existing processes
  • Assist with internal projects to develop and optimize process and product Life Cycle
  • Management and ensure robustness, repeatability, and scalability of cGMP operations.
  •  Support the execution of process risk assessments, qualification protocols and reports, and other operational activities that increase safety, reduce operation costs, and maintain cGMP compliance
  •  Interact with multi-disciplinary groups and ensure effective communication.
  •  Work both independently and collaboratively as part of a team

Who You Are:
Minimum Qualifications:


  • Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science field
  • 3+ years in process development, engineering, and/or manufacturing experience
  • Experience with cGMP manufacturing and Quality Systems within a regulated environment



  • Master’s degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science field
  • 1+ years in process development, engineering and/or manufacturing experience
  • Experience with cGMP manufacturing and Quality Systems within a regulated environment



Preferred Qualifications:

  • CMO experience
  • Experience with the biopharmaceutical manufacturing process
  • Proficiency in reading, understanding, and improving manufacturing-facing and/or client-facing process documentation
  • Familiarity with cGMP document control systems and general procedures
  • Excellent attention to detail, with superior documentation and organization skills
  • Excellent computer, verbal, and written communication skills, including strong technical writing ability




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
If you would like to know more about what diversity, equity, and inclusion means to us, please visit


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.