This position is responsible for managing a team of individual contributors, and all activities associated with incoming cGMP raw material sampling. In addition, this individual will work closely with the Manager of Distribution in coordinating other warehouse related activities including material movement, facility management, inspection preparedness and non-GMP material handling. The position will be accountable for driving operational safety, compliance and productivity in addition to serving as a key member of the supply chain management team.
This position is for the Administrative shift (M-F) with overtime and weekend support as needed.
Promoting a safe work environment through mentoring, monitoring and daily demonstration of safe behaviors.
Achieving site and operational goals by directly supervising the warehouse sampling team.
Provide direct leadership and mentoring to staff as it relates to cGMP sampling/inspection and other warehouse operations.
Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
Insure systems data entry (SAP, LIMS, etc.) is being entered correctly and timely.
Coordination of sample deliveries with the Sample Management and Distribution teams.
Implementing lean management principles, operational efficiencies and cost reduction opportunities while striving for Right First Time. Introduce new techniques/processes to the area, where appropriate
Create and maintain Standard Operating Procedures and applicable training documents to ensure department compliance.
Develop key performance metrics, and present monthly results to management.
Develop and support business continuity/risk management strategies within the Sample Lab and Warehouse.
Assist in the development of yearly budgets based on current and future business drivers.
Directly interface as needed with representatives of the FDA, other governing agencies, and companies for audits and other inspections.
Partner with a number of different groups (Human Resources, Quality Assurance, Supplier Quality Management, Dispensing, Supply Chain Procurement, Facilities and Engineering, Global Deliver Network, other Amgen sites) to insure efficient coordination and communication.
Ensure all staff is trained and remains current with all applicable SOPs, online training, etc.
Occasional travel to support regional and network Supply Chain initiatives
Doctorate degree OR
Master's degree and 3 years of Supply Chain experience OR
Bachelor's degree and 5 years of Supply Chain experience OR
Associate's degree and 10 years of Supply Chain experience OR
High school diploma / GED and 12 years of Supply Chain experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
4 years of experience in Quality Control, Laboratory or Sampling environment, as well as processing/interpreting material specifications from both company derived and USP, EP and JP standards.
2 years of GMP experience in a pharmaceutical and or commercialized biotechnology environment.
2 years previous supervisory experience.
Experience in developing, managing and leading staff.
Interpersonal communication and presentation skills.
Strong analytical and decision making skills.
Experience in managing and responding to compliance agencies/audits.
Experience with quality systems: investigations, change control, document management, SAP and LIMS.
Proficient in desktop software applications (e.g. Excel, Word and PowerPoint).
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.