Manufacturing Compliance Support Scientist

Merck•Saint Louis, MO

10d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

3+ years of experience in production.
Knowledge of cGMP/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.

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.