Front Line Manufacturing Manager (Bulk Drug Substance - Downstream)

Job Description

Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift at Amgen in Holly Springs, North Carolina. This is an on-site, full-time role. The position oversees teams of manufacturing associates responsible for the manufacture of GMP drug substances. The working schedule is based on a day shift (12-hour) rotation, working a 12-hour 2-2-3 schedule from 5:45am to 6:15pm.

Job Responsibility

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
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
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
Interacts with management in planning, developing and maintaining budget
Assist in developing and maintaining department goals

Requirements

Doctorate degree
Master's degree and 3 years of Manufacturing or Operations experience
Bachelor's degree and 5 years of Manufacturing or Operations experience
Associate's degree and 10 years of Manufacturing or Operations experience
High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice to have

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

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

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Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift

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