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 Senior Scientist - Plasmid Core.

The Senior Scientist will be primarily responsible for developing processes that can be scaled from shake flasks to 50-L scale microbial fermentations. 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.


The incumbent will work with the Training coordinator and Plasmid staff to expand the knowledge base and develop solutions to problems encountered during plasmid production and purification. Additionally, the SME 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:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 


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

  • Act as technical advisor to Technical staff to problem solve issues and overcome materials and equipment issues.
  • Devise 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.
  • Additional responsibilities include identifying and coordinating 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.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Perform tasks as assigned by leadership.
  • Work with technical staff and management to draft SOPs to govern operations.
  • Has fiscal responsibility for areas of oversight.
  • Other duties as assigned to meet the organization’s goals.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision.
  • Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
  • Developing and enforcing procedures and controls.
  • Approval of procedures established by junior staff.
  • Minimum travel required.
  • Frequent involvement in customer relations.
  • Mentoring and professional development of staff.
  • Exercise crucial people skills
  • Have significant latitude for making decisions for their operational or functional unit.
  • Drives timelines and development through broad influence. 


General Responsibilities:

  • Ability to work with highly confidential materials.
  • Experience with eukaryotic cells is essential
  • Extensive, hands-on experience with microbial fermentation methods:
  • Operating bench-top and lab-scale bioreactors.
  • Developing batch and fed-batch fermentation processes.
  • Execute upstream design of experiment (DOE) utilizing multi-reactor systems
  • Familiarity in USP, and ISO are critical.
  • Ability to lead teams of diverse backgrounds and experiences.
  • Highly skilled in Microsoft Office including data interpretation and reporting.
  • Attention to detail in all job functions.
  • Ability to manage and influence people in direct and lateral support structure.


Knowledge, Skills and Abilities required: 

  • Relevant four-year degree OR relevant Master’s OR relevant PhD in microbiology, molecular biology, biochemistry, or related field required.
  • Eight years relevant (w/4 YR degree) OR two years (w/Masters).
  • Experience in the manufacture of biologics or gene therapy required.
  • Must understand best practices in the preparation of aqueous reagents for use in phase appropriate clinical trials

 


Preferred Skills:

  • Understanding of large-scale plasmid production.
  • Experience using bioreactors.
  • GMP-experienced individual.
  • Experience in highly regulated field.

 

Minimum Physical Requirements

  • Sitting Constantly                           Frequently
  • Talking on the phone/in-person       Frequently
  • Typing on a computer keyboard      Frequently
  • Standing/walking                            Occasionally    


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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