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Process Development Scientist – Cell Sciences And Engineering

Process Development Scientist – Cell Sciences And Engineering
Empresa:

Amgen


Lugar:

Juncos

Detalles de la oferta

SUMMARY This role will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. The Process Development Scientist will work directly with the cell culture and/or fermentation science, biochemistry, and/or manufacturing processes. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies Provides input to new processes to generate robust and reliable data Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Ability to use cell science knowledge, theoretical understanding, and experience in the development, transfer and implementation of manufacturing processes. Keeps current and monitors the cell sciences field and other areas relevant to their function, including literature and technology development, and communicates relevant observations. Provides data analysis and interpretation and assesses impact of the data on the project; leverages advanced statistical knowledge and software. May introduce or transfer advanced scientific methods. Designs, monitors or conducts experimental strategies or projects which significantly contribute to attaining high priority goals under general guidance from supervisor. Conceive, plans and conduct scientific research/investigation in areas of considerable scope and complexity. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concepts. Develops and implements new and novel protocols to address specific issues. May support or lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility or process modifications. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. May develop supervisory and mentoring skills. Interacts effectively with variety of communication and working styles. Be flexible to support extended hours, non-standard shifts and manage changes. BASIC QUALIFICATIONS EDUCATION/LICENSES Doctorate degree earned by January 2019 OR Master’s degree and 3 years of Process Development and/or Technical Services experience in GMP regulated industry OR Bachelor’s degree and 5 years of Process Development and/or Technical Services experience in GMP regulated industry PREFERRED QUALIFICATIONS Education discipline/background in Life Sciences and/or Engineering Advanced skills in technical writing and presentation capabilities Consistent and highly advanced knowledge of cell culture and/or fermentation science, biochemistry, and/or manufacturing processes within the biopharmaceutical industry. Experience supporting Drug Substance facilities Working knowledge of pharmaceutical/biotech processes Advanced laboratory work skills associated to cell culture processes and equipment Advanced scientific analysis and troubleshooting skills Familiarity with documentation in a highly regulated environment Ability to interpret and apply GLP’s and GMPs Ability to apply science to a production environment Be organized, have multi-task project experience and be able to communicate & work well with other departments. Skills in the following areas: Verbal communication (English / Spanish) Problem solving Written communication including technical writing skills (English / Spanish) Project management Negotiation, persuasion and facilitation Collaboration Conflict Resolution Leadership and teambuilding Computer literacy (Windows environment: Word, Excel, Power Point). Fully bilingual (English/Spanish)


Fuente: Adzuna_Ppc

Requisitos


Conocimientos:
Process Development Scientist – Cell Sciences And Engineering
Empresa:

Amgen


Lugar:

Juncos

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