Supervisor, Drug Product Formulation & Autoclave

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Supervisor Drug Product Form & Autoclave supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate in a 24/7 model.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Provides on the floor leadership for a shift team of Manufacturing Associates

Oversees and coordinates the execution of the manufacturing schedule through daily shift assignments and huddles

Serves as the point of contact for escalations and provides guidance to resolve issues

Fosters an inclusive People-First Culture with regular communication conducting 1:1s on a defined cadence with direct reports

Maintains a safe and current good manufacturing practice (cGMP) compliant environment by ensuring direct reports have correct and up-to-date training

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

Enforces company policies that directly impact employees (e.g. time reporting time off approvals shift work and inclement weather)

Supports Factory Acceptance Testing (FAT) Site Acceptance Testing (SAT) Operational Qualification (OQ) and Performance Qualification (PQ) travel as needed

Manages and develops direct reports within the Formulation and Parts-wash/Autoclave teams

Administers company policies such as time off shift work and inclement weather that directly impact employees

Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.)

Coaches and guides direct reports to foster professional development

Participates in the recruitment process and retention strategies to attract and retain talent as needed

Addresses performance gaps employee questions and concerns and partners with HR as needed for resolution

Performs other duties as assigned

Basic Requirements

High School diploma/GED with 9 years of related experience in large pharma/biotech operations or projects;OR
Bachelors degree in Life Science Engineering or related field with 5 years of related experience in large pharma/biotech operations or project

Experience with electronic batch records root cause analysis technical writing and initiation of investigations

Preferred Requirements

Experience working in facility start-up environment
Experience working in a pharmaceutical manufacturing environment

Lean Six Sigma or similar certification

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
Will work in environment operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to stand for prolonged periods of time
Ability to sit for prolonged periods of time
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers
Ability to operate machinery and/or power tools
Ability to conduct work that includes moving objects up to 33 pounds
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions
Will work in warm/cold environments

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Manager

Position OverviewThe Supervisor Drug Product Form & Autoclave supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate in a 24/7 model.Company OverviewFUJIFILM Biotechnologies i...