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Technical Transfer Specialist
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.
The Technology Transfer Specialist is responsible for aspects of technical transfer and scale up in GMP manufacturing. The position’s primary function is creation and management of master batch records. This position is responsible for generating and maintaining master batch records in accordance with site policy and cGMP requirements. Technology Transfer Specialists will work collaboratively with Technology Transfer Scientists to generate and maintain master batch records based upon current preferred procedures, process flow diagrams, technical project knowledge, and client input. Responsibilities include:
- Drafting master batch records based upon established processes or process flow diagrams
- Participate in batch record review discussions
- Supporting timely review of batch record workflows within an EDMS by relevant departments and clients
- Complete updates to master batch records based upon process safety, new process knowledge, process deviations, industry best practices, and/or client input.
- Supporting updates and process improvements to the master batch record process
- Provide support for master batch record related comments and inquiries from internal and external project meetings
- Incorporation of established data integrity and technology advancements into production documents
Who you are:
- High School diploma or GED
- 2+ years of experience in cGMP regulated environment
- Bachelor’s Degree in Chemistry, Chemical Engineering, or other life science discipline
- 2+ years of experience in cGMP manufacturing, cGMP quality assurance, or cGMP documentation generation related role
- Technical writing proficiency
- Ability to manage multiple priorities and shift focus through the day
- Thorough understanding of MS office suite with a strong focus on MS Word
- Strong oral and written communication skills
- Detail oriented
- Ability to work independently and as a part of team
RSRMS MilliporeSigma Millipore Sigma
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 a 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.