What are the responsibilities and job description for the Director Manufacturing position at Abzena?
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 2 Directors of Manufacturing to join our Manufacturing Team who will be responsible for supporting multiple manufacturing commissioning projects at the new Sanford facility including but not limited to equipment staging, validation, vendor management, scheduling of Engineering conformation runs, and all other GMP enabling activities. Abzena is currently in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology.
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
- Actively manage, lead, mentor, and train all manufacturing employees in execution of Biologics manufacturing, including Upstream Cell Culture and Downstream Purification operations
- Recommend strategies for improving Manufacturing for top performance through the use of bioprocess engineering principles.
- Responsible for specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to senior management.
- Network with Process Development, Manufacturing, and Quality organizations to establish a reliable state of process control.
- Actively participate in technical transfer and implementation of purification processes including facility fit modeling based on client needs.
- Abzena is currently in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology. The candidate will be responsible to support multiple manufacturing commissioning projects at the new Sanford facility including but not limited to equipment staging, validation, vendor management, scheduling of Engineering conformation runs, and all other GMP enabling activities.
- Responsible for all activities involving aseptic technique and maintains production equipment with single-use materials as it relates to cell culture (Stir-Tank bioreactors, Wave bioreactors, incubators, shakers, and cell separation equipment).
- Provides detailed observations, analyzes data, and interprets results. Communicates these results to others.
- Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
- Reviews and approves SOPs, master batch records, and other cGMP documentation Prepares technical reports, summaries, protocols, batch records and quantitative analyses as needed.
- Change owner for implementation or revision of equipment, documentation, and material specifications.
- Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
- Develops effective working relationships with both internal and external partners.
- Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups.
- Provides input and feedback on performance of production associates and lab technicians.
- Operates to the highest ethical and moral standards.
- Complies with Abzena policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena business.
- Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals.
- Travels as needed between sites and to attend professional conferences, train on new technologies, and execute process transfer in support of clients.
- May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
Qualifications
Mindset and Behaviors
- I really enjoy developing people.
- I can create systems that didn’t exist previously.
- I can easily pivot when plans change.
- Believes in shared accountability across functions and levels.
- Exemplifies a growth mindset.
- Thrives in a diverse, inclusive, team-centric environment.
- Passionate about fostering a learning environment and an open-door policy.
- 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
- BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field.
- Minimum 8 – 10 years of experience with MA/MS or minimum 10- 12 years with BA/BS as an Upstream/Production Associate, or equivalent, in a GMP environment. Supervisory experience a must.
- Experience leading and developing frontline management/ supervision.
- Knowledge of mammalian cell culture for production of biopharmaceuticals and/or downstream purification production.
- Skill with aseptic technique, bioreactor operation and single-use technologies following SOPs, batch records and working within a cGMP regulated environment.
- Ability to organize workload, oversee workload of direct reports, and relevant resource requirements.
- Skill in leadership duties, to include time management and planning.
Nice-to-Have
- Previous customer facing experience (Customer service, sales, business development)
- Biologics, Single-use technology
- Previous supply chain or materials management experience
- Experience in a product or process development environment
- Previous work in a Greenfield environment
- Work Schedule and Travel Requirement
There will be 2 Director Roles: A/C (Sunday-Wednesday) & B/D (Wednesday-Saturday) with alternating Wednesdays
Travel Requirement
25% travel year one for training and site development (Bristol PA, San Diego CA)
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 employment
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.
Electro-Mechanical Assembler
Manufacturing Concepts -
Youngsville, NC
Mechanical Assembler
Manufacturing Concepts -
Wake Forest, NC
Assembly Technician
Manufacturing Concepts -
Creedmoor, NC
