It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing Science & Technology (MS&T) group is seeking a motivated individual to join our growing team as a Process Validation Lead.

Provide technical leadership within cross-functional teams with primary responsibility as subject matter expert in the strategy for process validation of unit operations within upstream, downstream, fill and visual inspection processes

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Head of MS&T, essential functions of the Process Validation Lead include at a minimum:

  • Define and implement process validation framework for Gene Therapy products
  • Implement consistent process qualification, process validation and continuous process verification strategies
  • Define strategy for execution of process performance qualification (PPQ) and product life cycle
  • Generate, review, and approve process validation protocols and reports
  • Lead development of studies around process hold time, thermal and mechanical stress and stability of drug products
  • Provide process validation input for selection of equipment and designing of single use systems
  • Lead establishment of drug product manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data
  • Troubleshoot process issues working with other department of the organization
  • Lead process validation related investigations
  • Lead and develop process characterization and process control strategies
  • Lead process validation studies
  • Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate high level of integrity
  • Maintain positive attitude
  • 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 performs tasks as assigned by leadership, as well as assigning tasks to junior staff
  • Work to specific measurable objectives requiring operational planning skill 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 procedures
  • Make decisions based on established procedures
  • Infrequent travel required
  • Moderate involvement in audits
  • Moderate involvement in customer relations
  • Other duties as assigned

 

Knowledge, Skills and Abilities required:

  • B.S. Degree in Chemical / Biochemical / Biomedical Engineering, Biological Sciences or Molecular Biology or Virology or other relevant major with 7+ years of progressive related industry experience. 
  • M.S. Degree in with + 5 years of progressive related industry experience
  • Ph.D. Degree with + 2 years of industry experience
  • Prior experience in viral vector space is desirable
  • Sound scientific background of process validation principles and statistics
  • Sound understanding of equipment/system design, validation, GMP concepts, quality systems
  • Ability to communicate clearly with diverse group of team members
  • Ability to drive sound decision making
  • Ability to drive project forward with collaboration
  • Ability to manage project using project management tools
  • Understand upstream and downstream processes to support Viral Vector or Biologics manufacturing
  • Experience in technical investigations
  • Ability to analyze and resolve technical issues
  • Analyzing, interpreting, compiling data, logical conclusions, recommendations & decision making
  • Naturally interested in strong documentation practices and detail oriented
  • Familiarity with software packages like: Visioâ, JMPâ, and MS Projectâ
  • 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

  • Sitting Constantly
  • Talking on the phone/in person Constantly 
  • Typing on a computer keyboard Constantly 
  • Moderate Standing/walking
  • Ability to occasionally lift
  • Ability to wear PPE on regular basis
  • The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. 
  • The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, and ability to adjust focus. 
  • Communicate using telephone and e-mail.

 

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.

 

 

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