Amgen Specialist Manufacturing - Drug Substance in Woburn, Massachusetts
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.
As part of the Amgen’s Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement attitude, and an unyielding focus on safety, quality, and compliance.
The Specialist Manufacturing position presents an opportunity for the candidate to merge leadership skills, technical knowledge of the operation, and general project management skills in support of Operational Excellence (OE).
Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations
Proactively monitor and draw conclusions around operational performance, which may include the utilization of SBOL (Synthetic Biology Open Language)
Participate on and/or lead cross-functional project teams
Identify, recommend, and implement improvements related to operations for the area
Support the development of new strategies related to operations for the area (e.g., Validation strategies, SOP revision strategies, etc.)
Serve as a document owner. Initiate, review, revise, and approve manufacturing procedures and SOPs. Ensure all procedures reflect current operations
Assess process performance by observation of floor operations and review of performance data.
Evaluate, plan, and implement solutions for process improvement opportunities
Provide troubleshooting support or may lead trouble shooting of production process operations
Provide training and related materials on procedural, operational and technical aspects of the process
Participate in the design and implementation of critical processes and/or facilities
Align with and reinforce cGMPs and safety requirements
May interact with representatives of regulatory agencies
Review and provide input to regulatory submissions
Provide manufacturing assessment of a proposed change
This is an Administrative Shift position
- Doctorate degree
- Master’s degree and 3 years of Manufacturing and/or Operations experience
- Bachelor’s degree and 5 years of Manufacturing and/or Operations experience
- Associate’s degree and 10 years of Manufacturing and/or Operations experience
- High school diploma / GED and 12 years of Manufacturing and/or Operations experience
Experience with investigations into manufacturing deviations and determination of potential manufacturing impact and root cause, and application of corrective actions
Experience interacting with representatives of regulatory agencies
Experience and working knowledge of quality systems including change control process
A comprehensive understanding of regulatory requirements and their applications in GMP environment
Experience participating in and helping to lead cross-functional teams
Experience in leading multiple, contending priorities in a fast-paced environment
Strong technical writing and presentation skills
Project management experience
Detailed technical understanding of bioprocessing unit operations
Skilled in performance of GMP production operations
Ability to communicate and collaborate with technical and management staff
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.