Upstream Supervisor (Biologics) - Day Shift

Fujifilm•Holly Springs, NC

17h•Onsite

About The Position

As an upstream supervisor, you’ll lead and inspire a team of manufacturing associates, supporting the start up of a new large scale cell culture facility. The Upstream area includes: A n inoculum lab, two seed reactor trains (each with 4 reactors of increasing size) , four 20,000L production reactors, a harvest suite, media preparation , and parts prep area. You and your team will work a 2-2-3, 12 hour shift schedule to support the ongoing activities in these areas. You’ll start out leading a team in project phase supporting commissioning and qualification efforts in addition to helping prepare the facility to be operational ready . It’s an exciting opportunity to help build out processes and procedures in preparation of the first GMP run later this year. Relocation Assistance Available

Requirements

High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects
Experience in manufacturing of biological products, familiar with GMP/GLP requirements
Previous experience leading, supervising or managing others

Nice To Haves

BA/BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects OR Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects OR Military Experience of equivalence

Responsibilities

Supports various commissioning and qualification activities
Lead and support your team in operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management
Responsible for building and executing a training plan for your team to prepare for the first GMP batches later this year
Mentoring and developing team members
Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees
Collaborate and coordinate cross functionally with various support groups as needed in support of start up activities
Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
Fosters an inclusive, people-first culture with regular communication, conducting 1:1s focusing on the development and success of your team
Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training , performing gemba walks , and having a safety and quality mindset culture within your team
Supports manufacturing investigations and continuous improvement projects
Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment
Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees