Manufacturing Support Associate 3 Drug Product

The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives oversees corrective and preventive action (CAPA) and coordinates batch planning all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

Collaborates with stakeholders to implement compliance initiatives and carry out regulatory assessments ensuring full alignment with industry standards and organizational goals
Promotes a robust organizational structure by effectively overseeing CAPA and compliance monitoring to maintain high performance standards while developing and implementing risk mitigation strategies
Provides expert guidance on regulatory changes and industry trends
Serves as a liaison between regulatory bodies and internal teams
Collaborates effectively with crossfunctional stakeholders to coordinate and execute comprehensive Annual Product Reviews ensuring alignment with regulatory requirements and promoting continuous improvement in product quality and process efficiency
Supports reliable production during regular operations
Leads troubleshooting as a process subject matter expert (SME)
Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
Identifies and/or drives highly technical improvement projects in Drug Product (DP)
Collaborates with crossfunctional teams (e.g. DSM MSAT and Tech Transfer) to recommend and perform updates to documentation ensuring accuracy and alignment with evolving processes and standards
Coordinates nonbatch activities and creation of associated documentation for changeover and PMs
Initiates or supports change management records investigations CAPAs and continuous improvement (CI) activities
Provides support during inspections and audits by assisting in the backroom or acting as a runner ensuring efficient access to required documents and information while maintaining organized and transparent audit processes
Performs other duties as assigned

Basic Requirements

High school diploma or GED with 8 years related experience in life sciences manufacturing OR
Associates Degree in Pharmaceutical Sciences Biotechnology Microbiology or a related field with 6 years related experience in life sciences manufacturing OR
Bachelors in Pharmaceutical Sciences Biotechnology Microbiology or a related field with 4 years related experience in life sciences manufacturing OR
Equivalent military experience or training

Preferred Requirements

Experience in drug product manufacturing sterile processing or quality assurance
Strong knowledge of cGMP FDA EMA and MHRA
Experience developing and delivering technical training programs
Experience with learning management systems

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to stand for prolonged periods of time Up to 60 Minutes
• Ability to sit for prolonged periods of time Up to 60 Minutes
• Ability to conduct activities using repetitive motions that include wrists hands and/or fingers

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 viaemail 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.

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.

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