MSAT Process Engineer

Sanford, NC, USA
Career Opportunity  
Your Vision. Our Mission. For Patients. 

Abzena is proudly opening a brand new, state of the art manufacturing facility in Sanford, NC. We are seeking an Associate II to join our MS&T group who will be responsible for being the custodian of manufacturing processes with strong collaboration from Process Development group.  Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.  Abzena CDMO is currently seeking a Associate II to join the Downstream MSAT to lead and support the planning and execution of cGMP clinical phase manufacturing operations.   

As a new state of the art facility, you will be a pioneer of our organization. If you meet our qualifications, find joy in doing this type of work for partners and towards treatment for patients, and would like to be part of an inclusive, agile, and learning culture - we would like to hear from you! 

Responsibilities 
  • Recommend strategies for improving unit operations procedures for top performance using bioprocess sciences principles and protein biochemistry.   
  • Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.  
  • Network with Process Development, Manufacturing, and Quality organizations to establish a reliable state of process control.   
  • Actively participate in technical transfer and implementation of cell culture processes including facility fit modeling based on client needs.  
  • Actively participate in process validation activities.   
  • Build, modify, and utilize digital data storage, visualization, and analysis systems such as JMP to enable site process monitoring and continuous process verification programs.   
  • Generate documents (technical memos, protocols, reports) related to process monitoring, product impact assessments, campaign end summary reports.    
  • Provides training as needed and ensures adherence to company policies and quality requirements.  
  • Abzena is currently in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology.  The candidate will have the opportunity to support multiple manufacturing commissioning projects.  
  • Perform other related duties as assigned.  
Qualifications 

Mindset and Behaviors 
  • Exemplifies a growth mindset. 
  • Thrives in a start-up, agile work environment. 
  • Thrives in a diverse, inclusive, team-centric environment. 
  • Passionate about learning and open to feedback.  
  • Believes in shared accountability across functions and levels. 
  • Described as curious, organized, resourceful, and thoughtful. 
  • Operates to the highest ethical and moral standards. 
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission. 
Must-Have  
  • Minimum Bachelor's degree in scientific or engineering discipline, or equivalent with at least 5 years of relevant downstream process engineering experience.  
  • Working knowledge of unit operations techniques.  
  • Well-experienced with operations of single-use technologies and aseptic processing techniques.  
  • Strong knowledge of MS Office including Excel, PowerPoint, and Word.  
  • Must have experience within biologics CMC that includes pilot plant and/or cGMP manufacturing.  
  • Must have experience in technology transfer from development into a cGMP Manufacturing.  
  • Must be able to demonstrate significant success in technical proficiency, scientific creativity, and collaboration with others.  
  • Must be able to clearly communicate scientific information both written and oral.  
  • Ability to present technical information to both technical and non-technical audiences is required.  
  • Must be able to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills.  
  • Strong organizational skills are required.  
Nice-to-Have  
  • Project management experience is a plus.  
Work Schedule and Travel Requirement 

Ability to travel between Abzena sites (Bristol PA, San Diego CA, and Sanford NC)  

Physical/Mental Requirement 

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm. 

Great Benefits: 
  • 100% Employer Paid Health, Dental, and Vision Benefits 
  • 100% Employer Paid Basic Life & AD&D, Short-Term Disability, Employee Assistance Program 
  • 5% 401k Employer Contribution through Fidelity 
  • 23 Days of Paid Time Off, increasing to 28 days after 5 years of employees 
  • Tuition Fee Reimbursement up to $5,250 per year for degree, certification, development programs 
Abzena is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identify and expression, parental status, protected veteran status, disability/handicap status, national origin, age, disability, citizenship status, marital status or any other characteristics protected by applicable laws, regulations and ordinances.