Specialist II, Analytical Development

Job description

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:

MilliporeSigma is seeking a motivated Specialist II- Analytical Development to join its dynamic and collaborative process development team at the Carlsbad viral vector CDMO facility. The successful candidate will play a key role in developing analytical methods to support viral vector process development activities, including method qualification and validation activities. The candidate will also act as a driver for continuous advancement in viral vector analytical science and operational excellence across functions.

The candidate will perform the following for this role:

·  Technical contributor on the development and execution of viral vector analytical methodologies for internal and external client projects. 
·  Able to apply sound scientific principles in executing development experiments, generating study protocols and reports, and analyzing experimental results to make data-driven decisions.
·  Interfacing with both internal and external customers as technical subject matter expert to routinely provide technical updates.
·  Able to contribute to the cross-functional technical transfers of analytical methods from and/or to internal and external sites.
·  Collaborating on method qualification and validation activities.
·  Able to effectively communicate with the technical leadership team, internal and external network partners, and the product management teams.
·  Applying Quality by Design (QbD) principles and incorporating statistical design of experiment (DoE) approach in the scope of method development and qualification work.
·  Developing new technical capability through continuous learning.
·  Routinely promoting a culture of continuous improvement within the analytical development team and championing initiatives to improve client service.

 

Who You Are:

Minimum Qualifications:

·  Bachelor’s Degree in Chemistry, Biochemistry, Biology, or similar life science discipline
·  3+ years of experience in pharma, medical device, biologics, or similar technical industries

OR

·  Master’s Degree in chemistry, Biochemistry, Biology, or similar life science discipline
·  1+ years of experience in pharma, medical device, biologics, or similar technical industries

 

 

Preferred Qualifications:

·  Experience with biologics analytical method development (HPLC, CE, qPCR/ddPCR, ELISA)
·  Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment
·  Knowledge of ICH quality guideline
·  Ability to apply advanced technical knowledge to complete complex projects
·  Effective communicator of scientific and technical ideas
·  Excellent organization skills and ability to prioritize projects and tasks to meet timelines
·  Experience with DoE using JMP or similar software for experimental design and analysis

 

 

 

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!

 

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 Colorado or New York City, 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.

Job Requisition ID:  258133

Location:  Carlsbad

Career Level:  C - Professional (1-3 years)

Working time model:  full-time .buttontext1722e80f7dc3f6d2 a{ border: 1px solid transparent; } .buttontext1722e80f7dc3f6d2 a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

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 Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. 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.

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