Associate Quality Scientist
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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Associate Quality Scientist position will be responsible for safely performing operations that support our manufacturing departments as well as performing stability/Release testing (DS/DP) and other customer requests. The candidate will be expected to meet and exceed customer and regulatory body quality expectations for a current Good Manufacturing Practice (cGMP) facility, as well as understand how continuous improvements help us achieve our departmental goals by increasing efficiencies. The position is within the ADC Stability and Release team. It involves testing in accordance with GMP requirements in a laboratory environment, which is routinely audited by customers and regulatory agencies. The Associate Quality Scientist may actively participate in audits and assist in resolving any audit findings. The position will report to Supervisor of QC.
- Perform (timely) analytical testing and other activities to support cGMP release, in process and stability testing of drug substances and drug products.
- Provide complete and accurate records consistent with quality guidelines and good documentation practice (GDP) requirements.
- Ensure quality through adherence to GMP requirements.
- Complete the volume of work required to achieve group/departmental goals and meet deadlines and communicate the status of operations and bring deviations to the attention of the supervisor.
- Provide complete and accurate records consistent with quality guidelines and GDP requirements.
- Perform complex assays and processes requiring a higher level of skill and knowledge as well as identify problems and limitations of the analysis.
- Perform advanced troubleshooting utilizing technical knowledge and theory.
- Design basic experiments, evaluate data, and draw conclusions.
- Provide logical explanations and potential solutions.
- Contribute to support functions of the lab (eg. Maintain equipment’s, prepare reagents, restock lab supplies, and waste disposal).
Physical Attributes:
- Additional needs may include the use of personal protective equipment such as a respirator or chemical protective clothing for extended periods of time.
- Occasional lifting and pushing up to 40 pounds may be required.
Who You Are:
Minimum Qualifications:
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science.
OR
- Associate degree in Chemistry, Biochemistry, Biology, or other life science discipline.
- 3+ years of analytical testing experience in a cGMP laboratory environment.
Preferred Qualifications:
- 1+ years of lab testing experience with Bachelor’s degree.
- Instrument experience such as UV, HPLC, GC, LCMS, UV, Solo VPE, CGE, and iCE is highly desirable.
- Familiarity with general laboratory instrumentation and troubleshooting capabilities for when problems occur; for example, identifying instrumental errors or subtleties in technique.
- Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon.
- Knowledge of safe chemical handling methods.
- Analytical capabilities, GDP and Data integrity and ALCOA.
- Strong oral and written communication skills.
- Ability to accurately perform procedures independently.
- Experience with Trackwise, Chromeleon, LIMS and SAP.
- Antibody drug conjugate (ADC) experience.
RSREMD
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
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Chemistry, Laboratory, Developer, Biochemistry, Science, Technology, Quality