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 an Operations Manager for Upstream Production. The Manager, Upstream Production 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 vector production 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 for their area of focus and help drive process improvements.  Work with other functional areas to achieve goals in the manufacture 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 Associate Director of Manufacturing, essential functions of the Manager, Upstream Production:

  • The Manager, Upstream Production will be responsible for overseeing the Upstream Production team in their daily activities.
  • Anticipate problems and removing obstacles to enable staff to perform tasks as assigned.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision.
  • Drives timelines and developments through broad influence.
  • Manage deviations and change controls for staff under their supervision.
  • Oversee corrective actions/ preventative action plans (CAPA) and track error rates.
  • Additional responsibilities include working with Management and Operations Staff in coordinating operations in the Clinical Manufacturing Facility to ensure operations goals are met.
  • Provide training to staff and encourage the expansion of the knowledge base of the team.
  • Cultivate a diverse and collaborative team environment. 
  • Utilize clear and concise communication to deliver high productivity and contribution to the success of department goals.
  • Review and approve SOPs and other controlled documents.
  • Encourage a clean and safe work environment.
  • Implements the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Adhere to good documentation principles and ALCOA in the support of all production activities.
  • Frequent participation in audits, customer relations, and responsibility for inspection outcomes.
  • Fiscal responsibility for functional area.
  • Responsible for hiring, development and related personnel processes.
  • Frequent interaction with legal services.
  • Support a cohesive, high- performing team.
  • Exercise crucial people skills.
  • Work with other functional areas to meet operations goals.
  • Significant latitude in making decisions for operations in their functional unit.


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.).
  • Prior supervisory experience in highly regulated field required. (cGMP/ GLP)
  • Ability to work with highly confidential materials.
  • Thorough understanding of GMP regulations, USP, and ISO are critical.
  • Highly Skilled in MS Office suite.
  • Ability to demonstrate discretion, judgement, and personal responsibility.
  • Demonstrate a high level of integrity.
  • Maintain positive attitude.
  • High degree in attention to detail.


Preferred Skills

  • Experience in the manufacture of biologics or gene therapy.
  • Experience in leading successful highly skilled teams.
  • Familiarity with eukaryotic cell culture science and biochemical procedures used in biological manufacturing.
  • Understanding of AAV vector science is preferred.

 

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

This position has been filled. Would you like to see our other open positions?