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Manager, Analytical Development
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.
Within the Biologics Viral Vector (BioVV) Process Development group, Analytical Development Manager will be responsible for the following: 1) execute projects including developing, validating, and transferring analytical and chromatographic methods for biologics molecules, 2) manage 6 – 9 analytical scientists and associate scientists to ensure smooth execution of client projects according to budget and timelines given to the project team, 3) Develop, transfer, and validate robust analytical methods required for successful drug development and manufacturing, 4) Support follow-up and troubleshooting on analytical methods, 5) Support process development, pharmaceutical development and pre-formulation studies with chromatographic methods, technical expertise and solutions, 6) Compile and analyze experimental data to generate process knowledge and decide on next steps, 7) Write development and validation reports and ensure their timely delivery, and 8) Prepare and present project updates to global project team and to upper management.
Who you are:
- PhD in analytical chemistry or equivalent with 5+ years or MS with 8+ years in the biopharmaceutical industry.
- 2+ years’ experience managing and coaching people.
- Proven track record in biochemical characterization and problem solving.
- Deep knowledge and hands-on experience with methods including but not limited to CE-SDS, SE-HPLC, cIEF, Biacore, host cell DNA (qPCR), host cell protein, immunoassay and other biophysical and biochemical methods.
- Excellent knowledge of method development, technology transfer, and validation required for successful biological development and manufacturing.
- Strong experience in review of data and manuscript of protocols and reports for analytical methods including protein chemistry, chromatographic, electrophoretic, spectroscopic and mass spectrometry techniques.
- Experience with protein formulation strategies and development is highly desirable.
- Demonstrated skills in time management on planning, prioritizing and streamlining.
- Customer communication experience.
- Solid and proven working knowledge of DOE for formulation development.
- Ability to critically analyze data using statistical tools and to compile technical reports.
- Knowledge of common and specific software in use in analytical labs.
- Experience of management analytical lab, budget & instrumentation.
- Work experience in CDMO industry.
- Comprehensive understanding of upstream and downstream process development for biologics.
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.