Technical Support Scientist 3

Contract - 12 + months

Summary:

Senior Scientist at a global medical device company with interfaces around the world. Looking to add members with strong science backgrounds and experience working in a regulated industry environment to a dynamic team in Global Incoming Material Technical Support.  This position will work with external suppliers and requires technical leaders with strong project management and problem-solving skills to work with cross functional team members in quality, purchasing, planning, manufacturing and regulatory to quickly adapt to changes that are occurring with our incoming materials. These materials include a large variety of chemicals and biologics supporting the diagnostic business. Looking for scientists who enjoy working in a fast-paced environment, adapt quickly to changing priorities and are motivated to deliver results. 

Primary Job Function 

Independently manage complex; long-duration projects; product improvements and investigations. Proactively identify opportunities for significant operational; process; or product improvements. 

Core Job Responsibilities 

Responsible for implementing and maintaining the effectiveness of the quality system. 

1. Project Management - Independently design; manage; and conduct complex long duration projects; product improvements; and investigations (supports Incoming Materials projects). 

2. Product and Process Improvement - Independently manage complex long duration projects; product 

improvements; and investigations. Recognizes opportunities and proposes novel ideas for significant 

operational; process or product improvements. Proactively identify opportunities for significant operational; process or product improvements. Perform or support test and process method modifications; considering CQAs; critical process parameters and analytical performance characteristics. Identify technical alternatives and make risk-based decisions within the area. Use technical data that interacts with multiple areas and processes. Provides diverse; independent technical data and insight to support risk management evaluation and assessment. 

3. Design Control & Risk Management - Effectively balances compliance risk and business risk to create and review documentation. 

4. Complaint and Internal Investigations - Independently manages complex investigations to resolution. 

Demonstrates advanced statistical techniques; MAIC and or project management tools. Provides audit inputs and support as required. 

5. Technical Support - Assist in resolution of multiple complex technical and quality issues across ADD Sites; TPMs, suppliers and or functions (instrument; reagents; software and commodities). Anticipate; recognize and resolve technical issues. 

6. Sharing Knowledge - Presents complex technical information to internal and external groups. Shares 

scientific information and expertise with customers and regulatory agencies. Experience mentoring and 

teaching others to facilitate timely resolution of product and process technical issues. 

7. Strategic and Results Orientation - Demonstrates fiscal responsibility through actionable recommendations and accomplishments. Translates top-level goals to specific goals and aligns activities with respective strategic business priorities. 

Position Accountability / Scope 

Receives infrequent direction; and provides work directions for other technical personnel. Identifies; 

understands and resolves technical problems and operational issues. Anticipates and avoids reoccurrences of technical issues. Utilizes appropriate experimental; statistical and project management tools. Applies specialized knowledge of product or process design; standardization; performance anchors and modes of control to create and review documentation. Maintains detailed knowledge and understanding of product or process design. Supporting purchased incoming materials.  

Minimum Education  

Higher Certificate; Bachelor degree in scientific or technical field is desired or relevant combination of education and experience.  

Minimum Experience / Training Required 

4 years’ related work experience.
Experience in an FDA regulated environment preferred.  

Advanced degree preferred. (Advanced degree(s) may offset required years of experience). 
Clinical Chemistry analyzer testing experience Preferred

LS Solutions is a privately owned minority certified niche consulting and managed solutions firm head quartered in Princeton, NJ servicing Life Sciences industry with international office locations in India, Singapore, Germany, Belgium and United Kingdom.