Amgen
Specialist, Manufacturing
US - Ohio - New Albany
Sponsorship not specifiedDetected 1 day ago
Data AnalysisProject ManagementProcess ImprovementGMPMedical DevicesResearchProblem SolvingWriting
About the role
- 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.
- Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.
Responsibilities
- This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance.
- They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations.
- You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems.
- As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations.
- Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support.
- Evaluate, plan, and implement solutions for process improvement opportunities.
- Support process monitoring parameters and control limits based off critical metrics and recommend improvements.
- Collect process-monitoring data and support the assessment of deviations.
- Provide support of timely process monitoring quarterly reports.
- Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Requirements
- Doctorate degree
Nice to have
- Detailed technical understanding of bio-processing and manufacturing operations
- Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
- Experience with change control process and change management
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Project management skills
- Excellent organizational, technical writing, presentation, and verbal skills
- Knowledge of data analysis and control charting
Compensation
- 107,545.40USD -145,502.60 USD
Equal opportunity
- 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, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.