Scientist II – GMP Operations - Viral Vector Production

It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing group is seeking a motivated individual to join our growing team as a Scientist II – Viral Vector Production.

The Scientist II Production role will learn all aspects of the adeno associated viral (AAV) vector production.  They will master procedures and be able to lead and coordinate their execution. The Scientist II will be responsible for adhering to cGMP principles while overseeing production teams in the production of AAV drug substances.  They will work with Management and Senior Staff to plan and execute operations goals. This role will share focus on the implementation and operation of suspension cell-based bioreactor and the adherent based vector production platform.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Operations Manager, essential functions of the Supervisor include at a minimum:

• Responsible for assisting and leading operations in the support of the production of viral vectors used in clinical trials
• Responsible for leading and performing daily operational activities related to the GMP manufacturing of biological products, by executing production processes including assuring the availability of materials and the proper documentation surrounding GMP activities and product quality.          
• Contribute to material inventory tracking
• Learn all areas of operation involved in production activities
• Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Draft and revise SOPs and controlled documents
• Uphold a clean and safe work environment
• Understanding of Industry guidelines for drug product fill is required
• Working knowledge of various aseptic filling methods, including automatic and manual is essential
• Respond to and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units
• Oversee and train junior staff in GMP operations in a regulated work environment.
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• 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
• Attention to detail in all job functions
• Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
• Identifies problems and proposes solutions.  Performs tasks as assigned by leadership
• Ability to work with some independence based on applicable experience
• Works in a diverse and collaborative team environment utilizing clear communication to deliver high productivity and contributes to the success of team and goals
• Documentation of all activities performed according to SOPs
• Adhere to good documentation principles and ALCOA in the support of all production activities
• Make decisions based on established procedures
• Nominal fiscal responsibility
• May require some travel
• Limited involvement in audits
• Limited involvement in customer relations
• Limited responsibility for inspection outcomes

 

Knowledge, Skills and Abilities required:

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Three years relevant (w/4 YR deg) OR no experience with (w/Masters)
• Experience in biologics or gene therapy preferred
• Experience in highly regulated field preferred
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment
• Must possess a client-focused mindset in daily tasks
• Must possess prior experience handling confidential information and the ability to maintain confidentiality
• Experience working with large scale eukaryotic bioreactors (PALL preferred)
• Ability to troubleshoot manufacturing issues when operating a bioreactor
• Experience performing large scale clarification and tangential flow filtration preferred.
• Experience with various aseptic connections preferred (KleenPak, Presto, Multi-purpose, Tri-Clamp).
• Familiarity in USP, and ISO are beneficial.
• Understanding of AAV vector science is preferred.

 

Minimum Physical Requirements

• Frequently Sitting
• Constantly Walking/Standing/Stooping
• Frequently Independently lifting up to 50 pounds
• Occasionally Talking on the phone or in-person
• Constantly Typing on a computer keyboard
• Ability to wear clean room PPE to execute production operations

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

 

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.