Associate Manufacturing Scientist

The businesses of Merck KGaA, Darmstadt, Germany•Temecula, CA

4d•$29 - $50

About The Position

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The Associate Manufacturing Scientist will perform routine laboratory operations associated with the manufacture and packaging of cell culture media and reagents for Life Science business unit resulting in customer satisfaction.

Requirements

High School Diploma or GED with 5+ years’ experience lab experience
Bachelor’s Degree in a Life Science discipline (Biology, Chemistry, Botany, etc.)
Capable of following directions outlined in Standard Operating Procedures, ability to accurately complete Batch Records while adhering to Quality and Regulatory requirements
Demonstrated knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, cell counters, microscopes, CO2 incubators, BioSafety Cabinets and centrifuges
Demonstrated knowledge in Sterile / Aseptic technique
Demonstrated knowledge in cell culture techniques is required, as well as a basic knowledge of antibody and protein production methods
Ability to handle biologically hazardous materials
Good computer skills with proficiency in Microsoft Word and Excel software programs
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 circumstance 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

Nice To Haves

Basic knowledge in the use of laboratory techniques such as sterile and aseptic techniques, buffer/media preparation, cell culture, large- and small-scale protein purification, and Western Blotting
Basic knowledge in western blot, cell-based assays and basic immunological / molecular techniques
Working knowledge of manufacturing ERP systems, Oracle or SAP

Responsibilities

On time Manufacture of products as needed per Planning department
Perform standard and new operating procedures
Execution of 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
Operating standard laboratory equipment
Preparation of routine solutions and reagents
Utilize software for data entry and record keeping 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)
Train other lab personnel in established procedures
Filling, labeling and packaging of products
Execute on objectives and planned schedules as outlined by supervisor
Contributes 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
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
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 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