It’s an exciting time to join us!

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

The Plasmid Production Senior Scientist is responsible for guiding all aspects of production in the Plasmid Facility. The Senior Scientist has a strong working knowledge of microbial systems, bacterial metabolism and current bioprocessing technologies, has a proven track record of developing processes for expression of plasmid DNA using microbial fermentation systems.

Working in close collaboration with the Associate Director, the Senior Scientist Responsibilities include devising fermentation production processes that can be scaled from sub-liter shake flask cultures to 200-L bioreactors, develop and review procedures and Batch Record forms for fermentation processes, assist in the technical transfer of fermentation processes from process development to research grade and GMP manufacturing.

Additionally, the Senior Scientist will troubleshoot issues as well as trend Critical Process Parameters and Critical Quality Attributes to aid in control of the process.  Trend errors and work with management to implement the appropriate CAPAs to drive process improvement. 

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Plasmid Center (APC)

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Associate Director - Plasmid essential functions of the Sr. Scientist - Plasmid Production include at a minimum:

  • 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
  • Identify and Coordinate development of experiments to fill knowledge gaps
  • Work with vendors to design and source new materials
  • Anticipate and troubleshoot issues with operations to avoid interruptions in production
  • Work with management to answer client questions regarding their product
  • Help develop training packages and foster a highly functioning team of technicians
  • Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as delegating tasks to junior staff
  • Work to specific measurable objectives requiring operational planning skills with little direct supervision
  • Responsible for providing leadership in daily operational activities related to the manufacturing of biological products, by leading and executing production processes.
  • Assuring the availability of materials and the proper documentation surrounding GMP activities and product quality
  • Responsible for setting and maintaining a professional standard within area
  • Responsible for working with Management to enact the strategic direction of the Andelyn Plasmid Center
  • Responsible for the mentoring, training, and supervision of junior staff to assure the proper operation of facility equipment as well as the adherence to appropriate and accurate documentation surrounding activities and product quality
  • Works in close collaboration with Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means
  • Works in close collaboration with Management to ensure new projects and technologies are sought for incorporation into the Plasmid area
  • 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
  • Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
  • Work to specific measurable objectives requiring operational planning skills with little direct supervision
  • Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
  • Documentation of all activities performed according to SOPs
  • Make decisions based on established procedures
  • Has fiscal responsibility
  • Infrequent travel required
  • Moderate involvement in audits
  • Moderate involvement in customer relations
  • Moderate responsibility for inspection outcomes
  • Influences hiring, development, and related personnel processes
  • Mentoring and professional development of staff
  • Other duties as assigned

 

 

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, process engineering, bioengineering or gene therapy industries preferred
  • Five years relevant (w/4 YR deg) OR two years (w/Masters)
  • Ability to work with highly confidential materials.
  • Experience with prokaryotic cells is essential
  • Knowledge and experience in aseptic technique, fermentation, cell culture, liquid separation techniques, and/or fluid handling.
  • Experience in biologics or gene therapy required
  • 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 highly 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
  • Frequently Talking on the phone or in-person
  • Frequently Typing on a computer keyboard
  • Frequent Standing/walking
  • Occasional Independently lifting up to 50 pounds
  • Frequently wear PPE regularly

 

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 may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties.

 

 

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