Sr Director/ Director of MSAT

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 Director/ Sr. Director to lead our MSAT group who will be responsible for being the custodian of manufacturing processes with strong collaboration from Process Development group.  

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
  • Overseeing the new facility startup from a technology, process and staffing standpoint.
  • Responsibility of overseeing the tech transfer process from process development to GMP and MSAT
  • Director will oversee all day-to-day GMP operations and is responsible for ensuring the GMP delivers all products in a timely, compliant, and fiscally responsible fashion.
  • Establish, characterize and maintain GMP manufacturing processes
  • Collaborates with Operations and Quality globally to successfully deliver products for regulatory approval and Commercial launch. Provide ongoing technical and problem-solving support to Operations and Quality.
  • Develop and translate process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc.) to ensure successful process scale up and tech transfer, and resolve complex process/product issues
  • Partners with the site management team in the identification and implementation of quality & productivity initiatives based on business needs and priorities.
  • Works with the site management team in the definition of needs and implementation of plans for enhancement of manufacturing capabilities for the site based on product pipeline and strategic needs: equipment, facilities, introduction of state-of-the-art technologies and systems.
  • Provides technical and regulatory leadership to assure an effective and compliant environment for current and upcoming manufacturing processes.
  • Leads to assure the best utilization of state-of-the-art technology and best pharmaceutical manufacturing practices for the continued development of existing manufacturing operations and site capabilities looking to the future.
  • Performs 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 
  • Bachelor or Master’s Degree in a Life Sciences discipline, Ph.D. preferred.
  • Minimum of 15 years' experience in Biotech Industry and/or R&D.
  • Proven track record in cGMP at scale manufacturing operations support, including problem solving and successful delivery of cross-functional technical projects.
  • Strong scientific background and expertise in biologics products with end-to-end understanding of CMC processes for GMP commercial and clinical operations.
  • Experienced people manager with proven ability to develop talent and to achieve results through teamwork and leadership of others, streamlined execution and innovation in a matrix business unit environment.
  • Strong leadership and communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
  • Demonstrated ability to effectively communicate R&D project targets to management, customers and staff.
Nice-to-Have 
  • PhD in relevant scientific or engineering discipline.
  • 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.