DESCRIPTION

The Process Development (PD) Laboratory at Andelyn Biosciences is seeking a highly motivated, organized, independent, and GMP-experienced individual for a Laboratory Specialist II position.  The ideal candidate will have a Bachelor’s degree in an AAV related field, have several years’ experience as a laboratory manager using a SAP system, and experience with equipment validation.  This position will be responsible for managing all regulatory and administrative functions in the Process Development Laboratory.

 

Schedule: Full-time (Benefits Eligible) 

 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Essential functions of the role include at a minimum:

·       Rapidly develop sufficient expertise to function independently with minimal supervision.

·       Work with the senior management in the PD department to ensure the laboratory is fit for use and in compliance with GxP practices.

·       Ensure work follows GxP practices including lab notebooks, research batch records, and SOPs.

·       Participates in a team environment, including fostering a culture of collaboration.

·       Responsible for overall management of laboratory equipment; calibrations, maintenance, quality review, capital equipment purchases, and validation efforts.  Responsible for timely installation of new equipment.  Ensure compliance with equipment design specifications. Partners directly with Quality, Engineering, and other departments to resolve issues.

·       Coordinate development activities with other departments in the organization to resolve issues related to product manufacturing, testing, and performance.

·       Participate in technical transfer efforts to research and GMP production laboratories, initiating change controls, training, etc.

·       Assist in vendor selection and ordering of materials used in development work, active participation all areas of the material control system and SAP software.

·       Supervise communication with outsourced testing laboratories to ensure timely and quality results are generated consistently. Ensure appropriate documentation and results traceability.

·       Trains and documents orientations for new lab users on laboratory organization, workflows, Quality System compliance, and Safety requirements.

·       Coordinates with Business Development team for client-related SAP and LabWare needs.

 

General Responsibilities:

 

·       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 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.

·       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

·       Exercise discretion, judgment and personal responsibility.

·       Demonstrate high level of integrity.

·       Maintain positive attitude.

Knowledge, Skills and Abilities required

·       Four years’ experience with relevant 4-YR degree OR no experience with relevant graduate degree

·       Experience in biologics or gene therapy preferred

·       Experience in highly regulated field preferred

·       Effective communication and interpersonal skills required.

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

 

 Minimum Physical Requirements

·       Sitting for extended periods occasionally (67-100%).

·       Talking on the phone/in person.

·       Typing on a computer.

·       Standing/walking (0-33% of the time).                                                                           

 

EOE M/F/Disability/Vet