Work Location: St. Louis, Missouri Shift: Yes Department: LS-SC-POKQC6 Cherokee QC 2nd Shift Recruiter: Guadalupe Barragan
Hiring Manager: Samuel Thomas Reinhardt
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma (CDMO), the Quality Scientist position will perform quality control activities in support of GMP products within the stability and release ADC (Antibody drug conjugates) team. The position will report to Supervisor of ADC testing team.
Shift: Monday through Friday from 8am to 5pm.
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.
Perform data review for GMP testing.
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.
Participate as needed in quality audits, provide complete and accurate records consistent with quality guidelines and GDP requirements.
Provide complete and accurate records consistent with quality guidelines and GDP requirements.
Interface with customers and cross-functional departments as needed.
Train personnel and act as a technical consultant as needed and lead process improvement initiatives.
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. Conduct training on complex analytical procedures.
Train and coach, the associates, and senior associates within the team
Contribute to support functions of the lab (eg. Maintain equipment's, prepare reagents, restock lab supplies, and waste disposal).
Physical Attributes:
Perform tasks while wearing personal protective equipment such as chemical protective clothing, goggles, respirator, gloves, etc.
Lift, push, and or pull up to 40 pounds.
Who You Are:
Minimum Qualifications:
Bachelor's degree in chemistry, Biochemistry, Biology, or other life science discipline
10+ years' experience in analytical chemistry.
OR
Master's degree or higher in life science discipline.
5+ years' experience in analytical chemistry.
Preferred Qualifications:
5+ years of cGMP experience in pharmaceutical, biopharmaceutical or similar industry
Experience with ICE, Solo VPE, UV-Vis, KF, GC, LCMS, IC, CGE, and HPLC is highly desirable along with Chromeleon software.
Strong technical writing and scientific reasoning
Experience with Trackwise, Chromeleon, LIMS and SAP.
ELISA, Data Integrity, and ALCOA.
Strong command of Microsoft excel word, smart sheets and power point.
Antibody Drug Conjugate (ADC) testing experience.
Experience in lean lab practices and continuous improvement initiatives.
Strong technical writing, root cause analysis and scientific reasoning.
Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon.
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.
