Manufacturing Associate I/II

Abzena Inc. • Bristol, PA

3d • Onsite

About The Position

The Associate I/II is responsible for performing large-scale bioconjugation processes for cGMP manufacturing projects. The associate performs functions related to the manufacturing, development, and processing of drug substances, ensuring product compliance and multiple tasks that ultimately provide Good Manufacturing Practices and on time delivery to the customer. The individual must be able to communicate production status, communicate problems to proper personnel and understand how it affects other aspects of the operation.

Requirements

• 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 and GxP 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 Corrective and Preventive Actions (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 Standard Operating Procedures (SOP’s)
• Trains 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level