Manufacturing Systems Associate

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 Manufacturing Systems Associate to join our Manufacturing team who will be responsible for supporting all aspects of Manufacturing and has expertise in one or all of the following areas: tech writing, investigations, ownership of deviations CAPAs, and change controls, BOM creation, operational scheduling, and manufacturing compliance within a cGMP biologics 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
  • Responsible for ownership of complex deviations including client communication and CAPA ownership 
  • Initiates overarching change controls to manage validated state of equipment and/or processes  
  • Assist in ensuring regulatory inspection readiness, as well as participate in maintaining facility GMP compliance
  • Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression
  • Work closely with Manufacturing operations and QA team to drive deviations to timely closure
  • Provide support in quality system programs such as Deviation, CAPA, Change Management
  • Serve as liaison between multiple groups including Manufacturing, Quality, Engineering, QC, and Process Development
  • Develop and support batch scheduling and ensure initial raw materials (BOM) is managed

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 
  • BS in Chemistry, BioChemistry or related scientific discipline preferred, or equivalent combination of education and experience
  • Minimum of 5 years manufacturing experience in an FDA/GMP environment required
  • Experience conducting GMP investigations within clinical/commercial manufacturing environment
  • Equivalent education and experience may substitute for stated requirements
Nice to Have 
  • Strong technical writing experience
  • Experience using quality management software (Mastercontrol, Trackwise, etc.) preferred
Work Schedule and Travel Requirement
  • Regular business hours or shift schedule
 
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.  Capable of accessing the manufacturing areas as needed. 
 
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.