Senior Manufacturing Manager

Amgen

(Thousand Oaks, California)
Full Time
Job Posting Details
About Amgen
Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.
Summary
The Senior Manager of Manufacturing provides leadership to the Manufacturing Specialist team that is responsible for the nonconformance and corrective/preventive actions (NC/CAPA) programs, the Change Control process, all validation of equipment cleaning, steam sterilization and automation and the documentation and training for critical production process operations. The Senior Manager and his/her support team is also accountable for EPO production and maintenance planning, forecasting and scheduling and work order administration. In addition, the Senior Manager of Manufacturing is responsible for personnel safety and environmental controls programs and general B7 business governance such as plant operational metrics, department budgeting, risk management and business continuity. The Senior Manager will also serve as the liaison for plant electronic systems and new technologies with Thousand Oaks site functions to help drive critical projects.
Responsibilities
* Understand GMP operations and the business aspects of a drug substance manufacturing facility * Knowledge of regulatory compliance requirements and cell culture processes * Experience with production equipment and automation systems, as well as, scheduling and production planning tools (i.e. Finite Scheduling and Maximo) * Manage projects, guide operational business, participate in plant governance and lead continuous process improvement * Ensure schedule adherence for tasks, including, but not limited to: manufacturing, validation and qualification, project planning and planned and unplanned maintenance activities across all shifts. In addition, present plant and organizational information to executive leadership and external stakeholders * Responsible for staff selection, training, oversight, performance evaluations and staff development * Ensure standard operating procedures are accurate and followed for executing GMP assignments to ensure critical disposition timelines are achieved * Identify and implement process and safety improvements, as well as, assist in the introduction of new products and technologies into the facility * Utilize appropriate systems for job duties (SAP/MES, QMTS, Maximo, LMS and LIMS etc.) and also work with spreadsheet and executive presentation applications * Interact with business partners and internal/external audit teams, including regulatory agencies, as well as, interact with external business partners to assist with scheduling of maintenance tasks, engineering evaluations, quality control sample submission and quality investigations
Ideal Candidate
* Doctorate degree and 2 years of Manufacturing and Operations experience * Master’s degree and 6 years of Manufacturing and Operations experience * Bachelor’s degree and 8 years of Manufacturing and Operations experience * Associate’s degree and 10 years of Manufacturing and Operations experience * High school diploma / GED and 12 years of Manufacturing and Operations experience * 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources **Preferred Qualifications** * Degree in Life Science, Chemistry or Engineering * 7+ years of related manufacturing experience * 5+ years of experience in a production Area Lead, Specialist or Manager role * Ability to lead at all levels of the organization and effectively partner throughout the organization and across functions * Demonstrated project management and presentation skills * Demonstrated experience with continuous improvement methodologies

Questions

Answered by on
This question has not been answered
Answered by on

There are no answered questions, sign up or login to ask a question

Want to see jobs that are matched to you?

DreamHire recommends you jobs that fit your
skills, experiences, career goals, and more.