drjobs Manufacturing Associate 4 - Drug Product Formulation

Manufacturing Associate 4 - Drug Product Formulation

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Job Location drjobs

Holly Springs, MS - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Position Overview

The Manufacturing Associate 4 in Drug Product Manufacturing is responsible for Component/Parts Preparation Thawing and Formulation of Drug Substance Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for DP including training of others. This position also supports and assists in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.

Company Overview

FUJIFILM Diosynth 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

Leads executes and documents manufacturing processing steps and/or manufacturing support activities process monitoring and control
Performs operations of Drug Product (e.g. Parts Washer Autoclave Formulation Filling and Visual Inspection)
Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
Owns the establishment of processes and trainings to become a trainer for coworkers
Maintains compliance of GMP documents and ensures own training level is complying and maintained
Supports and/or assist senior level associates or supervisor with scheduling daily activities on drug substance manufacturing floor as needed
This role may require shift work (weekend and potential for nights)
Performs other duties as assigned

Basic Requirements

High School Diploma or GED with 6 years of direct experience in a manufacturing environment
Associates degree with 4 years direct experience in a cGMP manufacturing environment OR
Bachelors with 2 years direct experience in a cGMP manufacturing environment OR
Equivalent Military training/experience
Prior cGMP experience from an aseptic pharmaceutical environment

Preferred Requirements

Experience with specific unit operations (e.g. Parts Washer Autoclave Operation Compounding/Formulation Filling with Isolator Technology or Manual/Automated Visual)
Understanding of manufacturing run cadence and order of shift activities
Experience with cGMP safety and operational procedures
A high degree of knowledge and expertise of the operation of specific production equipment

BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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 place. 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

ADA Information


Required Experience:

IC

Employment Type

Unclear

Department / Functional Area

Manufacturing

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