DESCRIPTION

Andelyn Biosciences is an industry leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV).  We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

 

We are seeking a Manager, Downstream Production and Aseptic Fill.  The Manager, Downstream Production and Aseptic Fill will lead and oversee a team of variously skilled and experienced technical staff.  The Manager will be responsible for training and guiding their team and developing the team’s skills.  Work with Management and Senior Operations staff to appropriately staff sterile filtration and aseptic filling of drug substance processes.  Maintain a workforce that is well trained and able to meet the challenges presented in everyday operations. A successful candidate will be able to learn current processes and improve them based on experience.  Work with other functional areas to achieve goals in the production and purification of a biologic drug substance.  Seek out new technology and techniques to improve the work processes.  Track production data and deviations to drive process improvement.  They will support a positive work environment to maintain morale in the team.   

 

Schedule: Full-time (Benefits Eligible) 

 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Director of Operations, essential functions of the Manager, Downstream Production and Aseptic Fill:

·       Responsible for overseeing the areas of sterile filtration and aseptic fill processes including aseptic process simulation.

·       Working with Management and Operations Staff in coordinating operations in the Clinical Manufacturing Facility.

·       Drive corrective actions/ preventative actions (CAPA) and track error rates.

·       Review and approve SOPs and other controlled documents.

·       Implements the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.

·       Adhere to good documentation principles and ALCOA in the support of all production activities.

·       Displays a high degree of attention to detail in all job functions.

·       Develop and enforce procedures and controls.

·       Perform in accordance with established policies, procedures, and techniques. 

·       Work to specific measurable objectives requiring operational planning skill with little direct supervision while driving timelines through broad influence.

·       Anticipate problems and removing obstacles to enable staff to perform tasks as assigned.

·       Mentoring and encourage the expansion of the knowledge base of the team.

·       Cultivate and support a diverse collaborative and high performing team environment. 

·       Utilize clear and concise communication to deliver high productivity and contribution to the success of department goals.

·       Will manage and influence staff in direct and lateral support structure.

·       Encourage a clean and safe work environment.

·       Maintain compliance with applicable regulatory requirements for gene therapy products.

·       Perform tasks as assigned by leadership, as well as delegating assignments to junior staff.

·       Frequent participation in audits, customer relations, and responsibility for inspection outcomes.

·       Has fiscal responsibility for functional area.

·       Responsible for hiring, development and related personnel processes.

·       Frequent interaction with legal services.

·       Exercise crucial people skills

·       Work with other functional areas to meet operations goals.

·       Has significant latitude in making decisions for operations in their functional unit.

·       Maintain positive attitude and work environment.

 

Knowledge, Skills and Abilities required

·       Relevant four-year degree OR relevant Masters OR relevant PhD.

·       Eight years relevant (w/4 YR degree) OR four years (w/Masters, PhD.).

·       Experience in the manufacture of biologics or gene therapy preferred.

·       Extensive experience and familiarity in the area of APS and aseptic processes.

·       Thorough understanding of industry guidelines for aseptic processing.

·       Prior supervisory experience in highly regulated field preferred. (cGMP/ GLP).

·       Familiarity with biochemical procedures used in biological manufacturing. 

·       Experience in AAV manufacture preferred.

·       Thorough understanding of USP, EP, and ISO are critical.

·       Experience in leading successful highly skilled teams is preferred.

·       Highly Skilled in MS Office suite.

·       Ability to demonstrate discretion, judgement, and personal responsibility.

·       Demonstrate a high level of integrity.

 

 Minimum Physical Requirements

·       Sitting Constantly (67-100%)

·       Talking on the phone/in person Constantly (67-100%)

·       Typing on a computer keyboard Constantly (67-100%)

·       Standing/walking Occasionally (0-33%)

                                                                                    

EOE M/F/Disability/Vet