Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Your Impact
To design, lead or contribute to projects for sourcing/insourcing/outsourcing changes of processes, raw materials and/or finished goods for the Chemical & Biological commodity. This includes collaborating with multiple Thermo Fisher groups, along with senior management and our external vendors to affect and/or implement change. Furthermore, encouraging technical relationships and handling conflicts with confidence and integrity. Effectively shift priorities and work at a rapid pace is required. Excellent interpersonal skills, including writing, articulating, listening, and questioning skills required. Ability to verbally communicate technical strategies and then translate those strategies into an accurate concise written document is important for success.
LOCATION: This is a fully onsite position based in Middletown, VA. Unfortunately, relocation assistance is NOT provided.
- Must be legally authorized to work in the United States without sponsorship now or in the future.
- Must be able to pass a comprehensive background check, which includes a drug screen.
What will you do?
- Experienced leader or project manager of cross-functional teams- facilitating communication, decision making, and ensuring alignment with internal and external stakeholders
- Develop or complete project tasks, deliverables, dependencies, and resource requirements.
- Track and communicate project status, plans, issues, timelines, action items, and budgets with immediate and executive leadership.
- Study product requirements, design testing and manufacturing systems to meet requirements.
- Perform statistical analysis to analyze trends, and work with team(s) to conduct root cause analysis and to recommend and implement corrective actions for processes.
- Investigate, design, & implement control systems & methods to ensure product quality and/or equivalency.
- Develop/implement strategies & sound recommendations based on both quantitative and qualitative inputs with intuitive understanding of quality, manufacturing, and financial drivers.
- Writing and completing validation plans and reports, as well as performing hands-on testing as needed to support validation activities.
- Manage change control processes and the implementation of new raw materials or suppliers.
- Establish and maintain supplier relationships to ensure timely and reliable sourcing of raw materials for internal stakeholders within the specialty diagnostics business group.
- Serve as the single point of contact and subject matter expert for sourcing needs.
- Execute focused global sourcing activities in partnership with suppliers spanning the Americas and EMEA regions.
- Other duties, as assigned.
Education
- High School Diploma/GED is a minimum required with 15+ years applicable experience.
- Or a degree in science or engineering field with applicable experience
- Bachelor’s +>7 years’ experience
- Master’s degree +5-8 years’ experience preferred
- PhD in science +3-5 years’ experience preferred
Knowledge, Skills, Abilities:
- Experience/Solid Understanding in new product development/introduction and stage gate process including material sourcing, supplier development, material qualification and finished good manufacturing.
- Knowledge/Experience in Microbiology, Chemistry and/or Molecular and Cell Biology. (strongly desired; not required)
- Ability to work a flexible schedule remotely, or inside a laboratory, or manufacturing environment; capable of managing schedule based on needs.
- Capable of leading or supporting cross-functional project teams.
- Outstanding interpersonal and communication skills (both written and verbal) – ability to communicate across all levels internally and externally
- Excellent problem-solving skills involving science and engineering.
- Highly organized with the ability to multi-task; capable of accomplishing work remotely.
- Flexibility and understanding of business impact to address immediate priorities and still manage deadlines with longer-term projects and initiatives.
- Knowledge of established Quality Systems, ISO regulations, Regulatory processes with respect to market access, and/or cGMP.
- Working relationships and negotiations with external suppliers.
- Thrives in a multifaceted work environment; has ‘can-do’ attitude.
- Attention to detail and exudes ability to be customer focused.
- Understanding of manufacturing processes, documentation, testing, and quality requirements for materials and finished goods manufactured for and/or by Thermo Fisher.
- Experience working in a manufacturing environment (preferred).
- Continuous improvement experience (lean, PPI, Six Sigma, 5S) a plus.
- Project Management and/or PMP certification a plus.
- Ability to travel domestically/internationally approximately <20% of the time.
