Manager - Manufacturing Services, Swing Shift (Multiple Positions)

Amgen•Holly Springs, NC

21h•Onsite

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager - Manufacturing Services, Swing Shift (Multiple Positions) What you will do Let’s do this. Let’s change the world. In this vital role, you will provide leadership and guidance to the team in our Manufacturing Services area. The essential position works a 12-hour 2-2-3 schedule from 9:30am to 10:00pm supporting our critical 24/7 manufacturing operations including Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations. As a member of the Manufacturing leadership team, you will work hand in hand with a multidisciplinary team to deliver robust equipment, procedures, and processes to operate the material handling flow and supporting equipment. This includes hiring and training the External Workforce required to support production operations of the plant.

Requirements

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

Nice To Haves

Proven managerial experience and/or proven technical expertise in a GMP manufacturing drug substance plant that utilizes Single Use technology, Dispensing, Inventory Control
Proven expertise in ERP-SAP and MES and inventory management
Cross-functional work experience in either Single Use Technology, Supply Chain, Process Development, and Quality or Engineering
Excellent communication and change management skills, with drive, a sense of urgency, high energy level and problem-solving abilities
Demonstrated ability to forge and maintain strong relationships with other functional areas
Ability to optimally develop and mentor staff to broadly build inventory management expertise to the internal site teams

Responsibilities

Lead a diverse and impactful team of External Workers in GMP operations
Be responsible for the safety and quality culture of the department and champion continued improvement
Monitor and take appropriate actions to ensure adequate warehouse capacity is available
Oversee inventory control and cycle count process
Serve as owner of Material Transfer Equipment (e.g., preventative maintenance, operability, etc.)
Own and/or provide input and support for quality system records (deviations, change control records, CAPA and SOPs) or other records (e.g., business continuity plan, user requirement specifications and risk assessments)
Assess impact of new requirements, changes, processes, regulations to the department
Align with the broader organizational strategy and deliver continuous improvement
Support regulatory inspections for areas of responsibilities including evaluating complex compliance issues and developing playbooks for the inspections