Manufacturing Associate I, II, Senior - Production

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 a 3 Manufacturing Associates (I,II, and Sr Roles) to join our Manufacturing Team who will be responsible for performing all aspects of biologics upstream and downstream production in a single use facility. 

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 
  • Expect to work in a cGMP manufacturing environment.  
  • Operate in a Class 10,000 and Class 100,000 rooms.  
  • Perform all aspects of biologics upstream and downstream production in a single use facility including cell vial thaw and flask expansion inside a Bio-Safety Cabinet (BSC), operation of wave/STR bioreactors up to 2000L, chromatography systems, and TFF systems  
  • Conduct activities in support of production schedules as directed by senior staff.  
  • Expected to adjust to a flexible work schedule including weekend work.  
  • Obtain and stock supplies as directed.  
  • Maintain GMP records to comply with regulatory requirements and assist with in-process testing.  
  • Ensure compliance to training on an activity prior to GMP execution.  
  • Review SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.  
  • Support multiple projects simultaneously.  
  • Perform manufacturing and process development activities for projects and products in collaboration with others.  
  • Will cross-train on various tasks including Upstream and Downstream cGMP manufacturing to support overall success of the Biologics group.  
  • Review completed batch records daily for GMP compliance and completeness.  
  • Inventory manufacturing lab supplies and ensure items are properly stocked.  
  • Maintain records to comply with regulatory requirements and assist with in-process testing.  
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. 
Associate 1: 
  • 0 – 2 years of experience 
  • Technical degree or relevant combination of education & experience 
  • Strong mechanical aptitude 
Associate 2: 
  • All associate 1 plus:  
  • 2 – 4 years of experience 
  • 0 – 2 years of experience with technical MS degree 
  • Experience in either USP or DSP 
Sr. Associate: 
  • All associate 2 plus: 
  • 4+ years of experience in USP, DSP or both 
  • Strong technical and mechanical aptitude in bioprocessing 
  • Experience leading, training, and coaching peers 
Must-Have  
  • BA/BS degree preferred that included laboratory work in a chemistry, biology, chemical engineering or related field.  
  • At least 0 to 2 years of experience in a GMP pharmaceutical or biotech environment.  
  • Experience with aseptic handling required, including BSC operations to maintain the integrity of open cell culture operations.  
  • Knowledge of mammalian cell culture processes  
  • Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities  
  • Skilled with using single-use technologies, including tube welding, tube sealing, and disposable systems  
  • Ability to follow detailed instructions and to maintain accurate records.  
  • Ability to work effectively in a team environment.  
  • Effectively communicate status of floor operations to leads  
  • Able to efficiently operate multiple projects and multitask when required.  
  • Ability to safely operate production equipment in accordance with established practices.   
Nice-to-Have  
  • Experience in USP or DSP 
  • Technical MS degree  
Work Schedule and Travel Requirement 

Flexible work schedule as needed  

Travels as needed between GMP facilities.   

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.