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, preclinical, clinical and commercial quality.

 

The SME is responsible for supporting the Viral Vector Core (VVC) Operations team by overseeing all aspects of AAV Manufacturing (USP and DSP).  This includes ensuring the cell culture activities needed to meet the production schedule are planned, work with purification lead for DSP activities, supporting the preparation and inventory of solutions, insuring supply of reagents and materials, and organizing the daily workloads.  The SME will write and manage technical proposals for VVC productions and attend client meetings as necessary. The SME will work with the Business Team to obtain critical production information and communicate technical information to clients and the team as needed.  The SME will be responsible for assuring on time completion of VVC productions and communicate possible solutions to the director if there are impacts to the timeline.  The SME will lead investigations and troubleshoot technical production issues as well as trend data and work with management to identify areas for process improvement.   

 

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 Viral Vector Core, essential functions of the Scientist II - VVC:

·       Provide support leading a diverse team in day-to-day viral vector manufacturing activities (USP/DSP) and provide technical expertise.

·       Manage project flow from initial client contact to delivery of final product.

·       Successful candidate must demonstrate personal leadership initiative, judgement and accountability.  

·       Operate within the Quality System applicable to the manufacture of research grade, toxicology grade and engineering runs with grade appropriate material to support preclinical studies.

·       Maintain compliance with applicable regulatory and safety requirements for BSL2 lab and ensure delivery of high-quality gene therapy products.

·       Work with Materials Management to manage inventory and materials (SAP), responsible for identification and approval of secondary source materials.

·       Perform technical tasks as required, maintain documentation, and store records in accordance with established company policies, procedures and protocols.

·       Ensure accurate documentation of all activities performed according to established SOPs.

·       Identifies problems, troubleshoots and finds suitable solutions.

·       Work under general supervision of the Associate Director.

·       Manage decisions by acquiring feedback, input and consult as required.

·       Fiscal responsibility to work within budget and emphasis on reducing waste and increasing efficiency.

·       Write technical process plans, reports and proposals for all preclinical manufacturing and assist with RFP responses and proposals.

·       Consistently makes significant contributions to the achievement of the goals and objectives for the company and the team.

·       Work to establish processes to assure on time delivery (OTD) of deliverables.

·       Highly effective communication skills both written and verbal.

·       Encourage a supportive team culture using our guiding principles and core values.


 Additional Functions:

·       Demonstrate high level of integrity and adaptability.

·       Maintain positive attitude.

·       Other duties as assigned.


Knowledge, Skills, and Abilities Required:

·       Bachelor’s degree with 8+ years relevant experience OR Master’s degree with 6+ years relevant experience OR Ph.D. with 1-2 years relevant experience required.

·       Hands-on experience with adherent and suspension mammalian cell culture for upstream production and/or downstream bioprocessing purification.

·       Demonstrate leadership, coaching and mentoring skills.

·       Highly effective communication and interpersonal skills.

·       Ability to work with highly confidential materials.

·       Demonstrate exceptional organizational, time management and problem-solving skills with an attention to detail.

·       Experience using single-use bioreactor systems, performing aseptic processes, and transferring manufacturing technology across departments a plus

·       Experience in Bioprocess Engineering, Gene Therapy, Biochemistry a plus.

·       Prior experience with viral vector research or manufacturing a plus.

·       Prior experience using SAP, Trackwise and Labware a plus.

·       Skills in operating a personal computer.  Must be familiar with various software packages (e.g., Word, Excel, PowerPoint).

 

 Minimum Physical Requirements

·       Sitting Constantly (0-67%)

·       Talking on the phone/in person Constantly (0-33%)

·       Typing on a computer keyboard Constantly (0-33%)

·       Moderate Standing/walking (33-67%)

·       Ability to occasionally lift 20 - 30 lbs. (0-33%)

·       Ability to wear PPE on regular basis (67-100) %

                                                                                   

 

EOE M/F/Disability/Vet

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