GMP Bioconjugation Manufacturing Associate I–II

Abzena Inc.; Massachusetts; On-site; USD 65,000 - 90,000; Full time

Job summary

Abzena in Massachusetts seeks an Associate I/II to perform large-scale bioconjugation processes for cGMP manufacturing projects. The role covers manufacturing, development, and processing of drug substances, ensuring compliance and timely delivery to customers.

The ideal candidate has a chemistry/biology/engineering background with GMP experience and a commitment to quality. Join a team focused on reliable, compliant operations and continuous improvement within a global CDMO framework.

Qualifications

• Bachelor’s degree in chemistry, biology or engineering.
• A minimum of 2 years’ experience in a GMP pharmaceutical environment preferred.
• Experience with cGMP manufacturing operations andGxP principles.
• Understanding and application of cGMP requirements.

Responsibilities

• Works in GMP environment and ensures regulatory compliance.
• Perform Manufacturing activities including:
• Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs, and Batch Records
• Batch Documentation/Record Generation
• Materials sampling, staging, dispensing, and return
• Equipment and Room set-up, operation, and cleaning
• Use of appropriate personal safety equipment and engineering controls
• In-process inspection and sampling
• Support investigational and quality systems activities
• Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment
• Participate in continuous improvement activities
• Interfaces and consults with other functions, such as process development, Quality Control and Quality Assurance
• Initiates deviations, assists in assessing product quality impact and assists with proposals for CAPAs
• Writes and reviews SOPs and other applicable cGMP documentation for Manufacturing
• Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols
• Ensures completion of equipment logs and batch records
• Ensures cleanliness and proper assembly of manufacturing equipment and manufacturing areas per approved procedures (SOP’s)
• Ensures accuracy of SOPs
• Train s on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
• Operate to the highest ethical and moral standards.
• Comply with Abzena’s policies and procedures.
• Communicate effectively with clients, supervisors, colleagues and staff.
• Participate effectively as a team player in all aspects of Abzena’s business.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Perform other duties as assigned.

Education

Bachelor’s degree in chemistry, biology or engineering

Job description

Abzena in Massachusetts seeks an Associate I/II to perform large-scale bioconjugation processes for cGMP manufacturing projects. The role covers manufacturing, development, and processing of drug substances, ensuring compliance and timely delivery to customers.

The ideal candidate has a chemistry/biology/engineering background with GMP experience and a commitment to quality. Join a team focused on reliable, compliant operations and continuous improvement within a global CDMO framework.