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

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

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.

Responsibilities

• Works inGMPenvironment and ensures regulatory compliance.
• Perform Manufacturing activities including:
• • Performs a variety of complex tasksin accordance withcGMP,cGDP, SOPs, and Batch Records
• • Batch Documentation/Record Generation
• • Materials sampling, staging, dispensing, and return
• • Equipment and Room set-up, operation, and cleaning
• • Use ofappropriate personalsafety equipment and engineering controls
• • In-process inspection and sampling
• • Support investigational and quality systems activities
• • Assistmaintenance in the performance of preventative maintenance activities,troubleshootingand repair of equipment
• • Participate in continuous improvement activities
• Interfacesand consultswith other functions, such as process development, Quality Control and Quality Assurance
• Initiates deviations,assistsin assessing product quality impact andassistswith proposals for Corrective and Preventive Actions (CAPAs)
• Writesandreviews SOPs and other applicable cGMP documentation for Manufacturing
• Ensures proper execution of Master Batch Records, standard operating procedures, and validation protocols
• Ensurescompletion 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)
• Trainson and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
• Operate to the highest ethical and moral standards.
• Comply withAbzena’s policies and procedures.
• Communicate effectively with clients, supervisors,colleaguesand 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, andmission.
• Perform other duties as assigned.

Qualifications

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

Physical Requirements

• Ability to stand for3-4hours at a time, sit for1to2hours at a time.
• Frequently lift and or move objects up to 30 pounds.
• Stand/walk during entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.

FLSA:

** **Non-Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

This job description requires the handling, supervision, management, or otherwise exposure toRCRAhazardous waste as defined at 40 CFR (Code of Federal Regulations), parts 239 – 289.