Manufacturing Compliance Support Scientist

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 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.
  
  

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.

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