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Scientist II – GMP Operations - Cell Culture

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Apr 1, 2023

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Job Details

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 – Cell Culture

The Scientist II Cell Culture 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 cell culture teams in the production of AAV drug substances. This role will be responsible for the maintenance of the eukaryotic cell line. Participate in the generation of reagents such as buffers and other critical raw materials used in the manufacture of viral vectors.  They will work with Management and Senior Staff to plan and execute operations goals.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Corporate Center (ACC)

                  1180 Arthur E. Adams Dr.

                  Columbus, OH 43221

 

Under the guidance and direction of the Cell Culture Supervisor, essential functions of the Scientist II - Cell Culture 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
  • 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 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 degree, 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 and understanding of eukaryotic cell culture
  • Ability to wear job specific clean room PPE for extended periods of time

 

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.    

 

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 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.

Company

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn's scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. The name "Andelyn" is a hybrid of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. "Andelyn" combines their names, representing all the families who have courageously participated in the research that make today's gene therapies possible. Continuing Andelyn's patient-based mission, the company is opening two state-of-the-art commercial manufacturing and development sites. The Dublin-based Andelyn Development Center is set to open in May 2022 and will house Andelyn's preclinical and development services. The 185,000 square foot Andelyn Corporate Center located on The Ohio State University's Innovation District will open for production in mid-2022.  

Company info
Website
Phone
614-580-8522
Location
1180 Arthur E. Adams Dr.
Columbus
OH
43221
United States

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