Manufacturing Associate II/ Sr Associate

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 Senior Associate/ Associate II is responsible for performing large-scale bioconjugation or small molecule chemistry 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.
• Performs 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, 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)
• Review, Update and Provide input in drafting of Master Batch Records.
• Trains on and understand all policy and procedures including Regulatory, Safety, SOPs, Work Instructions, etc.
• Lead and/or manage other manufacturing associates.
• Train other Manufacturing Associates as needed.
• 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 3 years’ experience in a GMP pharmaceutical environment
• 1 years of commercial or late phase manufacturing experience
• Experience with cGMP manufacturing operations and GxP principles.
• Understanding and application of cGMP requirements.
  
  

Experience In Either Of The Following

Downstream Biologics or Bioconjugation Manufacturing:

• Preparative purification of biological molecules (antibodies, carrier proteins, viruses, viral vectors, or other biological molecules).
• Normal flow filtrations and tangential flow filtrations (UF/DF) manual and automated skids.
• Experience with optimization of bioprocesses.
• Direct hands-on experience with preparative chromatography systems (AKTA Pilot, AKTA Ready, AKTA Explorer, etc.).
  
  

Small Molecule Chemistry

• Lab and pilot scale glass reactors and temperature control systems.
• Normal Phase and Reverse Phase purification systems, such as flash chromatography or HPLC Prep.
• Vacuum oven drying and Lyophilization.
• Handling of Highly Potent Compounds, including work with PAPR and Gloveboxes/Isolators.
• Distillations, filtrations, separations, and additional general chemistry lab practices utilizing lab or pilot scale equipment.
  
  

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.