Manufacturing Supervisor, Upstream

Genezen•Indianapolis, IN

17h•Onsite

About The Position

Genezen is a gene therapy company that provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. The Manufacturing Supervisor, Upstream promotes a safe working environment, trains and develops the manufacturing team, plans on-time batch execution, delivers quality and safe viral vector products, and continuously improves manufacturing processes. The position is located in Fishers, Indiana, and reports to the Director of Manufacturing. The role leads and supports upstream manufacturing personnel and operations for clinical viral vector batches. It oversees resource scheduling, material staging, equipment preparation, batch execution, cleaning and sanitization, inventory transactions, and batch-record review. The supervisor also manages personnel development and performance, manufacturing systems and procedures, operational investigations and corrective actions, and compliance with company and regulatory standards for quality, environmental health and safety, and cGMP. The schedule may need to change to support production activities and business needs. The position includes regular floor work in a BSL 2 environment with personal protective equipment and aseptic gowning, around pharmaceutical-facility machinery and utilities. A criminal background check is required.

Requirements

Prior leadership experience in a GMP manufacturing facility.
Ability to adhere to internal company and regulatory policies, processes, and procedures, including EMA and FDA requirements.
Hands-on experience writing and reviewing documentation.
Experience in biomanufacturing unit operations.
Good written and oral communication skills.
Bachelor’s degree in Biology, Microbiology, Chemistry, Virology, or another relevant field is listed as desired.
In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting is essential.
Four to six years of related work experience in a GMP environment.
Demonstrated interpersonal skills to build relationships, act as a change agent, manage conflict, and adapt to changing organizational and business needs.
Ability to manage multiple priorities.
Adaptability to schedule changes based on business needs.
Ability to work in a BSL 2 environment with personal protective equipment and aseptic gowning, and to perform the stated physical activities, including lifting up to 25 pounds frequently and up to 40–50 pounds occasionally.
Corrected 20/20 vision to assist with visual inspection of Drug Products.

Nice To Haves

Experience in a comparable position, preferably in an industrial organization.
Technical knowledge of adherent and suspension cell lines, including cell thawing, scale-up, bioreactor inoculation, transfection, harvest, and clarification.
Experience with or knowledge of Cytiva XDR 50L, Cytiva XDR 500L, Univercells Scale-X Carbo, and Cytiva iCELLis 500 bioreactors.
One year of supervisory experience.
Drug Substance experience with cell culture and upstream viral vector manufacturing.
Experience using single-use systems.

Responsibilities

Provide leadership, coaching, and mentoring to Upstream manufacturing personnel.
Oversee and execute upstream viral vector manufacturing, including resource scheduling, material staging, equipment preparation, batch execution, cleaning and sanitization, inventory transactions, and batch-record review.
Provide on-the-floor training and support for upstream operations for clinical viral vector batches.
Hire, coach, and develop manufacturing team members, including performance management and periodic reviews.
Monitor and report area performance, identify improvement opportunities, and implement process improvements.
Design, implement, maintain, and continually improve vector manufacturing systems, policies, procedures, and programs to meet company and regulatory Quality and EHS standards.
Identify and mitigate manufacturing risks that could negatively affect product or personnel safety.
Manage manufacturing production activities, including personnel development, problem solving, deviation investigations, root-cause analysis, CAPAs, Change Controls, and 6S.
Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department.
Perform other duties as assigned.