DESCRIPTION

Andelyn Biosciences is an industry leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV).  We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

We are seeking a Subject Matter Expert (SME) for Downstream Purification - The Downstream Purification Subject Matter Expert is responsible for supporting operations by leveraging knowledge of the relevant science and cGMP principles to address issues encountered by the production teams.  They will be responsible for knowing and understanding current procedures.  The Subject Matter Expert will trend Critical Process Parameters and Critical Quality Attributes to aid in control of the process. 

 

The SME will identify areas in need of improvement and create projects to improve the current processes.  The Subject Matter Expert will work with Training Coordinator and Supervisors to expand the knowledge base of the staff.

 

Schedule: Full-time (Benefits Eligible) 

 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Associate Director of Manufacturing, essential functions of the Downstream Purification – Subject Matter Expert (SME):

  • The Downstream Purification Subject Matter Expert will act as technical advisor to Operations staff to problem solve issues and overcome materials and equipment issues.
  • 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 Quality Assurance to answer client questions regarding their product.
  • Help develop training packages and foster a highly functioning team of technicians.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Work with staff in Operations and Quality Assurance to draft SOPs to govern operations in the clean room.
  • Involvement in audits, customer relations, and responsibility for inspection outcomes as needed.
  • 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.
  • Frequent involvement in audits
  • Significant responsibility for inspection outcomes
  • Frequent involvement in customer relations
  • Exercise crucial people skills.
  • Have significant latitude for making decisions for their operational or functional unit.
  • Drives timelines and development through broad influence.


Knowledge, Skills, and Abilities required

  • Relevant four-year degree OR relevant Masters OR relevant PhD.
  • Six years relevant (w/4 YR degree) OR four years (w/Masters).
  • Experience in the manufacture of biologics or gene therapy.
  • Experience in highly regulated field preferred. (GLP, GMP)
  • Ability to work with highly confidential materials.
  • Experience with eukaryotic (adherent and Suspension) cells is essential.
  • Understanding of AAV vector science is beneficial.
  • Thorough understanding of bioprocessing principles.
  • Familiarity in USP, cGMP and ISO are critical.
  • Must have an understanding of best practices in the preparation of aqueous reagents for use in phase appropriate clinical trials.
  • Ability to make clear decisions in times of high stress in a critical timeline based on experience and understanding of protocols and regulations to effect problem resolution.
  • Highly skilled in Microsoft Office including data interpretation and reporting.
  • Attention to detail in all job functions.

 

Preferred Skills

  • Prior supervisory experience is highly preferred.

 

Minimum Physical Requirements

  • Sitting Constantly (67-100%)
  • Talking on the phone/in person Constantly (67-100%)
  • Typing on a computer keyboard Constantly (67-100%)
  • Standing/walking Occasionally (0-33%)

                                                                       

EOE M/F/Disability/Vet

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