Scientist II - Bioreactor Production

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.

The Scientist II Bioreactor Production 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 2 will be responsible for adhering to cGMP principles while overseeing production teams in the production of AAV drug substances. They will work with Management and Senior Staff to plan and execute operations goals.

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 Scientist II – Bioreactor Production:

Responsible for assisting and leading operations in the support of the production of viral vectors used in clinical trials.
Coordinating and leading operations in the formulation of critical solutions used in the production of viral vectors in bioreactors for clinical trials.
Contribute to material inventory tracking.
Learn all areas of operation involved in our production scheme.
Provide training to staff.
Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation.
Draft and revise SOPs and other process documents.
Uphold a clean and safe work environment.
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.
Perform tasks as assigned by leadership, as well as delegating assignments to junior staff.
Ability to work with some independence based on applicable experience.
Adhere to good documentation principles and ALCOA in the support of all production activities.
Moderate involvement in audits, customer relations, and responsibility for inspection outcomes.
Has fiscal responsibility for areas of oversight.
Other duties as assigned to meet the organization’s goals.
Support a cohesive, high- performing team.
Limited responsibility for inspection outcomes
May require some travel
Limited involvement in customer relations.

Knowledge, Skills and Abilities required

Relevant four-year degree OR relevant Masters OR relevant PhD.
Four years relevant (w/4 YR degree) OR two years (w/Masters).
Experience in the manufacture of biologics or gene therapy required with understanding of AAV vector science is preferred.
Experience working with large scale bioreactors (PALL preferred).
Ability to troubleshoot manufacturing issues when operating a bioreactor.
Experience in highly regulated field preferred (cGMP/ GLP).
Ability to work with highly confidential materials.
Familiarity with biochemical procedures used in biological manufacturing.
Experience with eukaryotic cells is essential (suspension cells preferred).
Experience performing large scale clarification and tangential flow filtration preferred.
Experience with various aseptic connections preferred (KleenPak, Presto, Multi-purpose, Tri-Clamp).
Familiarity in USP, and ISO are beneficial.
Experience with first air principles working in a biological safety cabinet.
Understanding of AAV vector science is preferred.
Ability to lead and perform in highly skilled teams of diverse backgrounds and experiences.
Experience in performing in highly skilled teams is preferred.
Maintain positive work environment.

Minimum Physical Requirements

Sitting Constantly (0-33%)
Talking on the phone/in person Constantly (0-33%)
Typing on a computer keyboard Constantly (0-33%)
Standing/walking Occasionally (67-100%)
Lifting weight at 45lbs or greater (33-67%)
Ability to wear clean room PPE (100%)

· EOE M/F/Disability/Vet