Analytical Method qualification Expert (m/f/d)

Posted 09 Feb 2024

Corsier-sur-Vevey, Vaud - Switzerland

Req Id 270433

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role:

Reporting to the “Analytical Operations & Quality Control Lab Manager” in the Global Analytical Development organization, Analytical method qualification Expert role represents an opportunity to work in a team of highly empowered employees and significantly contribute to the startup of high-tech GMP analytical laboratories, by executing the plan for procedural landscape for the analytical GMP laboratories and supporting the commissioning, qualification and validation for analytical systems. Once functional, this role will give you direct responsibilities in ensuring method qualification and tech transfer activities are compliant to regulatory and internal requirements, contributing to their continuous improvement, supporting investigations and reporting, to ensure the delivery of our specialty innovator Biotech pipeline to patients. This position will also be responsible for support efforts related to analytical life cycle management by managing and leading efforts related to ongoing method robustness and continuous improvement through method optimization and re-validation.

 

Your key responsibilities in this role are:

 

  • Act as a subject matter expert for analytical method validation/qualification, verification and tech transfer activities of traditional and advanced analytical techniques, including but not limited to: HPLC, electrophoresis, UV-Vis Spectroscopy, ELISA based methods, digital PCR, Microbiology related methods, MS etc.
  • Lead the design of method qualification activities as well as relevant risk assessments where applicable.
  • Draft technical documents, including validation protocols and reports, risk assessments, and analytical test procedures.
  • Interpret complex data and solve scientifically challenging problems by providing direction and leadership.
  • Support method transfer activities for assigned projects.
  • Contribute to QC robotic platform qualification activities.
  • Support the investigations of method performance and reliability, and proposes improvements as needed.
  • Directly interact with our business partners on a regular basis, including analytical development, process and quality stakeholders and testing laboratories in the network.
  • Manage, investigate and close events and deviations, non-conformities, investigations, change controls and CAPAs.
  • Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.

Who you are:

  • Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology.
  • 5+ solid hands-on experience in method development/validation/verification and tech transfer activities within the scope of physico-chemical, electrophoretic bioanalytical and microbiological methods.
  • Extensive knowledge in DoE, data analysis and statistical evaluation of qualification data sets.
  • Knowledge of analytical robotic platforms in QC context is considered as a significant plus.
  • Thorough understanding and practical application of cGMPs and regulatory requirements (Swiss, FDA, EU,..).
  • Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
  • Previous direct experience in audits and interactions with healthcare authorities
  • English fluent, French is an asset.

 



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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


US Equal Employment Opportunities

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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

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