It’s an exciting time to join us!

The Andelyn Biosciences’ Plasmid group is seeking a motivated individual to join our growing team as a Scientist II - Plasmid Production

The Scientist II Production role will learn all aspects of Plasmid 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 plasmid DNA.  They will work with Management and Senior Staff to plan and execute operations goals. 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the GMP Manager - Plasmids essential functions of the Scientist II - Plasmid Production include at a minimum:

  • Responsible for assisting and leading operations in the support of the production of plasmids used in viral and non-viral clinical manufacturing.
  • 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
  • Provide training to staff
  • 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 that occur at any point during the assigned period of responsibility
  • 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.
  • 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:

  • 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

 

 

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

                                                                       

                                                                       

 

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.

 

EOE M/F/Disability/Vet

 

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.

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