Manufacturing Associate I/II

Abzena; Bristol Township (Bucks County); On-site; USD 55,000 - 75,000; Full time

Job summary

Abzena in the United States is seeking an Associate I/II to support large-scale bioconjugation manufacturing under cGMP. This role covers manufacturing, development, and processing of drug substances to ensure quality and on-time delivery to customers.

You will communicate production status, work with process development, QC and QA, and contribute to continuous improvement while following safety and regulatory requirements. This is a hands-on, on-site role in a dynamic biopharma setting.

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 and GxP principles.
• Understanding and application of cGMP requirements.

Responsibilities

• Works in GMP environment and ensures regulatory compliance.
• Batch Documentation/Record Generation and materials handling.
• Equipment setup, operation, cleaning and calibration.
• Participate in continuous improvement activities and CAPA proposals.
• Interfaces with process development, Quality Control and Quality Assurance.
• Ensure proper execution of Master Batch Records and SOPs.

Skills

GMP experience

cGMP

GxP principles

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 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.

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 and GxP principles.
• Understanding and application of cGMP requirements.

Physical Requirements

• Ability to stand for 3-4 hours at a time, sit for 1 to 2 hours 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 to RCRA hazardous waste as defined at 40 CFR (Code of Federal Regulations), parts 239 – 289.