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.

The Supervisor, Validation - Analytical Development will be responsible for managing a team of scientists and will oversee the planning, execution, and analysis of development experiments, developing, qualifying, and validating new equipment and associated process/methods/assays, and extensive writing and documentation (e.g. SOPs and analytical test methods, qualification/validation protocols and reports, etc.).  The Validation Supervisor will be responsible for maintaining proper staffing levels, ensuring staff are appropriately trained, addressing personnel matters and escalation of issues to management when necessary. 

 

Schedule: Full-time (Benefits Eligible) 

 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Head, Analytical Development, essential functions of the Supervisor, Validation - Analytical Development: 

  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.
  • Work toward broad goals for area of responsibility.
  • Have significant latitude for making decisions for their operational or functional unit.
  • Exercise crucial people skills.
  • Ability to manage and influence people in direct or lateral support structure.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision while driving timelines through broad influence.
  • Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
  • Attention to detail in all job functions.
  • Developing and enforcing procedures and controls.
  • Mentoring and professional development of staff.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
  • Has budgetary responsibility.
  • Responsible for hiring, development and related personnel processes.
  • Drives timelines and development through broad influence.
  • Make decisions based on established procedures.
  • Demonstrate high level of integrity.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
  • Maintain positive attitude.
  • Other duties as assigned. Has fiscal responsibility for areas of oversight.
  • Other duties as assigned to meet the organization’s goals.
  • Support a cohesive, high- performing team.
  • Limited responsibility for inspection outcomes
  • Limited involvement in customer relations.

 

Knowledge, Skills, and Abilities required

  •       Relevant four-year degree OR relevant Master’s OR relevant PhD.
  •       Eight years relevant experience with 4-year degree OR four years relevant experience with Master’s OR two years relevant experience with PhD.
  •       Experience in biologics or gene therapy preferred or extensive experience in highly regulated field.
  •       Highly skilled in Microsoft Office products including data interpretation and reporting.

 

Preferred Skills

  • Prior supervisory experience is highly preferred.

 

Minimum Physical Requirements

  •       Sitting Constantly (33-67%)
  •       Talking on the phone/in person Constantly (0-33%)
  •       Typing on a computer keyboard Constantly (0-33%)
  •       Standing/walking Occasionally (67-100%)
  •       Lifting weight at 45lbs or greater (33-67%)        
  •       Ability to wear clean room PPE (100%)                                                                          

 

EOE M/F/Disability/Vet

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