Front Line Manufacturing Manager (Downstream) - Holly Springs, NC

Company: Msccn
Location: Holly Springs
Posted on: April 1, 2026

Job Description:

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Let’s do this. Let’s change the world. In these vital and dynamic roles you will be an on-shift front line manager in manufacturing. The working schedule is based on a day or night shift (12-hour) rotation. As a manufacturing leader you will oversee teams of manufacturing associates with differing levels of experience who will be responsible for the manufacture of GMP drug substances. Through structured on the floor presence, you will champion a safe and compliant production environment. As an active participant and role model in a Lean and continuous improvement culture, the manager will imbed these principles onto the manufacturing floor. Through your leadership, you will oversee teams in technical, on the floor operations in a biotechnology production operation. In addition, you will support the development of your staff through coaching, hiring, and mentorship. Font-line Manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering short- and long-term Amgen Operational goals. Responsibilities Compliance: Ensure safe working environment Ensure Amgen policies are followed, including cGMP and CFR (Code of Federal Regulations) compliance of assigned areas Evaluate current operating procedures and recommend changes to management to optimize production. Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes Interact with regulatory agencies as needed Assure proper gowning and aseptic techniques are followed Staff Supervision: Engage staff and build relationships of trust and respect while driving team performance and continuous improvement Recruit, train, evaluate, coach and develop staff Mentor and coach staff members to live by the Amgen Values Develop and implement trainings plans and programs, to ensure staff are prepared and compliant Ensure adherence to production schedule and maintenance activities Interacts with management in optimizing organizational structure and responsibilities Ensure plant safety through auditing, evaluations, and cross functional walks Ensure gowning and aseptic techniques training programs are maintained Process/Equipment/Facilities: Demonstrate technical mastery of manufacturing processes Collaborate with cross-functional teams (i.e., QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) in completing production activities Develop, implement and assess CAPAs and solutions to complex problems Responsible for elevating and resolving problems during daily operations Oversees set up, execution, and completion of critical manufacturing processes/tasks Administrative: Interacts with management in planning, developing and maintaining budget Assist in developing and maintaining department goals Additional Qualifications/Responsibilities What we expect from you We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these qualifications. Basic Qualifications Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Bachelor’s degree in Life Sciences or Engineering Demonstrated strong leadership skills and technical understanding of biotechnology production operations Experience in biotechnology or pharmaceutical plant start up Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation) Previous knowledge and experience within a cGMP environment 5 years process experience in a cGMP manufacturing facility 3 years of experience in a production Area Lead, Specialist or Manager role Strong leadership and teambuilding skills (coaching, mentoring, counseling) Experience with performance management including performance reviews Conflict Resolution, analytical problem solving, and project management skills Thorough understanding of regulatory requirements Excellent verbal and written communication (technical) skills Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems Salary Range 111,714.00 USD - 139,899.00 USD

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