Sr. Specialist 2, QC Program Management Technical Transfer and Sample Support

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About the Role

 

The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

 

What You'll Do

 

• Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they relate to QC Sample Plans and DS/DP Specifications.• Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans and QC Specifications.• Leads, authors, and reviews change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable.• Manages and directs the continuous improvement of QC Sample Plans and QC Specifications.• Applies holistic quality system approach through identifying and solving technical and compliance gaps and areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation.• Leads and participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA.• Ensures compliance with platform, procedures, and global QC vision.• Supports management in training compliance with policies and inspections.• Supports regulatory requests, audits, and inspections.• Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer requirements.• Provides guidance and feedback for QC personnel development.• Performs other duties, as assigned

 

Minimum Requirements

 

• Bachelors in Biological Sciences, Engineering, or related science field with 5+ years of relevant experience OR• Masters in Biological Sciences, Engineering, or related science field with 3+ years of relevant experience• Prior experience of project management experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)• 1-3 years’ experience in a GMP environment• Prior experience in leading technical writing initiatives.

 

Preferred Requirements 

 

• Experience with Customer Relationship Management• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)• Prior experience in leading project improvement management.

• Lean/6S certification 

 

Working & Physical Conditions

 

Ability to discern audible cues

Ability to inspe