Scientist III

Job Description

Job Summary:

• This position is responsible for manufacturing of particles products and completes associated documentation adhered to standard operating procedures (SOP) and current good manufacturing practices (cGMP) with the highest level of quality and compliance in a safe and timely manner that will meet customer expectations.
• Works with team members and biologicals to manufacture or qualify material.
• Participates and/or lead in process improvement projects.

Duties and Responsibilities:

• Manufactures particles products, starting materials, and particles seeds following cGMPs.
• Performs analytical and functional testing of particles products and raw materials per requirement
• Provide leadership to accomplish continuous improvement in quality, manufacturing cycle time and total cost by advocating and driving the PPI Business System within the operations.
• Represents Particles group in cross-functional meetings, understands particles scheduling, and supports material qualifications.
• Updates documents via Master Control change control (MOC) and Oracle ECO process.
• Writes, reviews, executes and leads process validation as needed.
• Initiates, evaluates, and supports investigations for non-conformances, CAPAs and deviations. Completes documentations.
• Weighs, transfers, and mixes required chemicals.
• Review and approves batch records and receives materials in ERP QAD.
• Performs ERP QAD transactions for work orders and inventory.
• Leads 5S and participate in Kaizen and other process improvement efforts
• Participates in weekly lab clean-ups and expired material segregations, and monthly cold box clean-ups.
• Maintains and orders lab supplies as needed.
• Initiates and/or participates process improvement projects such as updating processes and/or equipment to improve efficiencies and supports business needs.
• Leads and trains other chemists on equipment and procedures.
• Writes, reviews, or modifies SOPs, work instructions and reports.
• Maintains and analyzes lot histories for trends and discrepancies.
• Maintains, troubleshoots, and validates equipment as appropriate.
• Keeps department manager/supervisor updated on all issues.
• Performs other job duties as required to meet business needs.

Requirements/Qualifications:

• B.S. Degree in Chemistry, Industrial Engineering, or other scientific/technical discipline required.
• A minimum of 5 years of industry related experience with expertise in particles manufacturing environment.
• Extensive previous experience in diagnostic manufacturing environment with through knowledge of a variety of laboratory chemicals, potentially hazardous chemicals, human source materials, and reagent manufacturing activities.
• Advanced understanding and ability to adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics.
• Strong technical skills in manufacturing techniques, FDA, GMP, ISO 13485 compliance, process. improvement and process development.
• Exceptional supply chain optimization expertise and project management experience.
• Practical understanding and experience with IT systems (ERP, MES, WMS etc.)
• Excellent communication, executive presentation, and leadership skills with a collaborative approach to problem solving.
• Ability to lead, motivate and influence others.
• Superior organizational skills with ability to multi-task and balance complex and routine work activities.
• Collaboration skills – Able to effectively collaborate with peers in other operations and with colleagues in other businesses or divisions.
• Manual dexterity.
• Must be able to lift 25 lbs. routinely.
• May be required to lift up to 50 lbs. occasionally.