Lab Technician II

3 must haves:

• HS/AA/AS and 5 years experience or a BA/BS degree in a life science discipline or any related field experience 
• Must have experience with supporting R&D and Tech Transfer functions
• Must be able to pass a background and drug screen.

Essential Functions:
Successful manufacture of products
• Perform bulk laboratory operations such as fractionation of antiserum, dialysis, filtration, labeling and bottling, using available resources to coordinate daily manufacturing requirements.
• Perform various testing methods such as Heidelberger titers, total protein, OD280, IEP and SDS-Page
• On time Manufacture of products as needed per Planning department
• Perform standard and new operating procedures
• Execute complex laboratory methods per established procedures; support activities to resolve process and testing issues under guidance of senior staff
• Perform procedures involving calculations and material measurements. Collect and evaluate data per defined specifications
• Safely and correctly operate standard laboratory equipment
• Prepare routine solutions and reagents
• Utilize software for data entry and recordkeeping in conformance with company and regulatory policies and standards
• Ensure compliance with all quality and regulatory specifications
• Execute the manufacturing performance metrics (productivity, customer satisfaction and quality improvements)
• Execute on objectives and planned schedules as outlined by supervisor
• Train other lab personnel in established procedures
• Filling, labeling, and packaging of products
• Contribute to completion of specific programs and projects
•??Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
• Develop, write and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and/or ISO compliance

Problem-solve Manufacturing-related issues:
• Actively participate in troubleshooting and the identification of manufacturing and production issues
• May assist with the research of new methods or steps in a process at direction of team management, including revising SOPs

Improve manufacturing processes:
• Identify inefficiencies and opportunities for process improvements
• Assist in the implementation of manufacturing procedures intended to optimize existing processes, such as yield, time and cost, and ensure achievement of regulatory and customer requirements

Support new product development:
• Support R&D and Tech Transfer functions in bringing new products to manufacturing
• Train on new SOPs, technologies etc. to support the manufacture of new products

EDUCATION & EXPERIENCE:
• Bachelor’s degree in a Life Science discipline with related experience, preferred. In lieu of Bachelor's degree in a Life Science discipline, a minimum of 5 years of specific and demonstrated experience may be considered
• Basic knowledge in the use of laboratory techniques such as sterile and aseptic techniques, buffer, and large- and small-scale protein purification

KNOWLEDGE, SKILLS & ABILITIES:
• Demonstrated knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, microscopes, BioSafety Cabinets and centrifuges
• Demonstrated knowledge in Sterile / Aseptic technique required
• Demonstrated knowledge in cell culture techniques is required, as well as a basic knowledge of antibody and protein production methods
• Demonstrated ability to follow directions outlined in Standard Operating Procedures; ability to accurately complete Batch Records while adhering to Quality and Regulatory requirements
• Basic knowledge in cell-based assays, and basic immunological/molecular techniques
• Ability to properly and safely handle biologically hazardous materials
• Working knowledge of manufacturing ERP systems, Oracle or SAP preferred
• Good computer skills with proficiency in Office 365 and Excel software applications
• Ability to solve simple and complex mathematical equations
• Ability to multi-task and meet manufacturing production schedules with a sense of urgency
• Good organizational skills and attention to detail
• Good verbal and written communication skills including the ability create clear, concise written reports and accurate completion of batch records
• Ability to follow, write, and edit Standard Operating Procedures
• Adherence to Quality and Regulatory requirements/programs
• Ability to adapt to rapidly changing business circumstances and to thrive in a constantly changing business environment
• Demonstrated knowledge in laboratory safety plans and procedures to ensure compliance with applicable federal, state and local regulations
• Self-directed and self-motivated with the ability to work independently as well as in a team environment