Senior Bioanalytical Operations Manager (full-/part-time) (all genders)

Posted 09 Feb 2024

Darmstadt, Hessen - Germany

Req Id 272015

 

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: Are you looking for an exciting opportunity where you can make a significant impact on clinical development programs? Join our team as a Senior Bioanalytical Operations Manager (BAOM) and contribute to the success of our innovative NBE/NCE and ADC clinical development initiatives. As the BAOM, you will play a crucial role in the BioSample Operations group within Global Development Operations. You will provide scientific and technical oversight while ensuring the smooth execution of operational processes and delivery of clinical bioanalytical data from our trusted Contract Research Organization (CRO) partners. Your expertise will directly support the advancement of our clinical programs. This role can be based flexible in EMEA region; remote working possible.

 

Main Responsibilities:

  • Represent the BioSample Operations group on multiple clinical study teams, addressing requests related to Pharmacokinetic (PK) and immunogenicity data.
  • Oversee scientific and technical aspects, including the review of raw PK concentration results, immunogenicity data, and bioanalytical reports.
  • Ensure efficient sample flow and data transfer processes for clinical PK and immunogenicity studies.
  • Support contracting activities with bioanalytical CROs, including contract execution, change orders, and document filing.
  • Assist in budget planning for outsourced bioanalytical and validation studies.
  • Support publication of bioanalytical study reports in the regulated database.
  • Facilitate document filing for inspection readiness.
  • Ensure compliance with timelines, quality standards, guidelines, and internal protocols in outsourced bioanalytical studies.
  • Organize meetings and maintain meeting minutes.

Who You Are:

  • Ph.D., Master's, or Bachelor's degree in biomedical sciences or related fields, coupled with 5+ years of post-graduate experience in the life sciences industry.
  • Experience in clinical PK and immunogenicity sample analysis, such as LC-MS/MS, ELISA.
  • Regulatory knowledge of clinical PK bioanalysis is a plus.
  • Experience in clinical study management is an advantage.
  • Familiarity with bioanalytical CRO partnerships is desired.
  • Working experience in a GLP or GCP regulated environment.
  • Good understanding of drug development and discovery processes is beneficial.
  • Proven project coordination and/or project management experience.
  • Proficiency in Microsoft, knowledge of Microsoft Project Planning software is a plus.
  • Ability to communicate effectively at all hierarchies.
  • Intercultural understanding; used to act in a global matrix organization.
  • Fluent spoken and written English is required.


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

If you are a resident of California, Colorado, New York, or Washington, 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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