Senior Associate QC Scientist

Work Your Magic with us! Start your next chapter and join EMD Serono.

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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

• Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation
• Assist with training of newer laboratory staff as needed
• Performs peer review
• Work in a safe manner and ensure the lab stays in an audit ready and clean state
• Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Exercise judgment within generally defined procedures and practices
• Solve problems and make decisions with minimal assistance
• Maintain projects and timelines with minimal oversight
• Meet with internal project groups to keep projects on track
• Perform instrument Performance Verifications (PV) as needed
• Manage assigned change controls and CAPAs to ensure on-time completion
• Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes
• Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols
• Work cooperatively within the QC department and with other departments to achieve project goals
• Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
• Support all data integrity initiatives and strive for right first time

Who You Are:

Minimum Qualifications:

• Bachelor’s Degree in Chemistry, Biology or other Life Science discipline
• 3+ years’ experience in a GLP or cGMP analytical laboratory environment

Preferred Qualifications:

• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
• Strong attention to details, communication skills both oral and written
• Knowledge and understanding of analytical chemistry techniques
• Perform work in analytical testing lab with hazardous and toxic chemicals

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!

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