Manufacturing Compliance Support Scientist Merck KGaA

• 3.8 St. Louis, MO Job Details $24
• $46 an hour 1 day ago Benefits Health insurance Paid time off Qualifications Laboratory experience Manufacturing facility experience Bachelor's degree Pharmaceutical manufacturing facility experience Full Job Description Work Your Magic with us! Start your next chapter and join MilliporeSigma. 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. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role As an ADC Manufacturing Compliance Support Scientist (MCSS), you will primarily provide "off-the-floor" support to the Antibody-Drug Conjugate (ADC) Manufacturing team. In this role, you will focus on reviewing completed batch records, production automation report support; oversight of CAPA/Deviation queue, Logbook compliance, and Operating Procedural compliance as well as occasionally updating operational procedures to ensure smooth, compliant, and efficient manufacturing documentation rotation.

Key Responsibilities:

Review batch records, logbooks, and associated documentation to ensure accuracy, completeness, and compliance with quality standards. Ensuring ALCOA+ principles are followed. Launch deviation reports as needed. Retrieval of production automation reports, to support the completion of the completed batch records. Perform oversight and communication to the production team for CAPA completeness compliance, providing notification of pending actions. Administer periodic review representation for operating procedures. Support cross-functional communication between manufacturing and quality teams. This role will be the primary representative for site huddle meetings, including CAPA, Deviation, and periodic review boards. Contribute to continuous improvement initiatives, process optimization, and troubleshooting within ADC manufacturing. Ensure safety and compliance with all company policies, cGMP requirements, and ICH guidelines.

Physical Attributes:

Lifting up to 50 lbs. Wearing protective equipment (e.g., respirators, chemical protective clothing) at times for report/equipment interfacing during manufacturing operations.

Who You Are Minimum Qualifications:

Bachelor's Degree in a scientific discipline (e.g., Chemistry, Biochemistry, or Biology). 1+ years of production/laboratory experience in a cGMP setting. 6+ months of experience with GMP batch documentation.

Preferred Qualifications:

3+ years of experience in production. Knowledge of c

GMP/ICH Q7

requirements. Experience with mono-clonal antibodies, antibody-drug conjugate manufacturing or other highly potent compounds. Strong communication and technical writing skills for SOPs and batch record review. Proficiency with Microsoft Office applications (Word, Outlook, Excel, etc.). Ability to work both independently and collaboratively across departments. Cross departmental effective communication is critical to success.

Pay Range for this position:

$24

• $46/hour.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

RSREMD What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!