Senior Biologics Manufacturing Associate - 24/7 Ops

Merck & Co.

Holly Springs (NC)

On-site

USD 75,000 - 110,000

Full time

14 days+

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Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior Manufacturing Associate to lead day-to-day operations on a 24/7 bulk drug substance manufacturing floor and help bring our new facility fully operational.

You will champion cGMP compliance, coach teammates, supervise production steps, and collaborate on commissioning, qualification, validation, and continuous improvement projects to ensure timely delivery of therapies.

Qualifications

High school diploma or GED with 8 years of experience in life sciences manufacturing or equivalent.
Associate degree with 6 years of experience in life sciences manufacturing.
BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing.
Equivalent military experience.

Responsibilities

Lead day-to-day operations on a 24/7 manufacturing floor.
Support commissioning and qualification of equipment.
Create and/or review procedures and SOPs.
Help onboard manufacturing staff and transfer or develop manufacturing business processes.
Support new item creation and single-use assembly transfer or design.
Champion safety culture and follow EHS protocols.
Lead, execute, and document manufacturing processing steps and support activities within your area.
Monitor and control processes with in-process testing.
Execute validation protocols per cGMP SOPs and provide approvals as needed.
Maintain training and qualifications; mentor junior associates.
Support daily floor scheduling and back-up to supervisor.
Lead troubleshooting for operational issues to restore production.
Assist supervisor with shift huddles and investigations.
Serve as area lead for cycle counts and materials management.