Combine knowledge of basic molecular biology with a technical understanding of Cepheid systems to play a key role within the Product Transfer Sustain and Support group. Support Manufacturing, Quality, Regulatory and Materials Planning/Logistics departments in assuring the continued production of cost-effective quality products. Identify and implement streamlined and improved processes in production.
ESSENTIAL JOB RESPONSIBILITIES:
+ Leads projects of medium complexity to ensure the continued production of cost-effective quality products and streamline processes
+ Drives market expansion product launch and labeling projects in support of International Market Expansion according to regulatory requirements, under the general guidance of more senior staff and/or core team
+ Successfully implements processes and post launch product improvements in production, including improvement and validation of test methods, training of personnel, and implementation of all supporting documentation (BOMs, SOPs, worksheets, Design History files, purchase specifications, etc.)
+ Performs testing of biological/chemical assays, as needed, to support ongoing Product Transfer activities and goals. Analyzes data and participates in root cause analysis and design of solutions. Writes reports compliant with FDA regulations
Education or Experience:
+ Bachelor’s degree with 2+ years of related work experience OR
+ Master’s degree in field with 0-2 years of related work experience.
Knowledge and skills:
+ Proficiency in Molecular Biology Techniques, mathematics and formulas used for chemical calculations
+ Proficient level with scientific functions in Microsoft Excel, and high agility in all other basic MS Office software. Proficient in the management/sorting/filtering/manipulation of large amounts of data in Excel spreadsheets
+ Excellent organizational and communication skills
+ Ability to successfully interact with multiple departments. Demonstrate strong ethics and teamwork
+ Ability to handle multiple projects simultaneously, with tight timelines, and progress independently in a timely manner
+ Ability to work in an office, laboratory and production environment
+ BS with 4+ years of experience or MS in Life Sciences or a related discipline with 2+ years of relevant professional experience.
+ Hands-on experience in Operations functions, including a solid understanding of batch records, bills of materials, logistics and inventory parameters, costing parameters, document management systems, ERP systems, etc.
+ Practical understanding and use of statistical techniques for data analysis
+ Experience with Real-Time PCR and Molecular Diagnostic Assays
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
Operating Company: Cepheid