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Scientist - Drug Substance Purification Sciences And Engineering

Scientist - Drug Substance Purification Sciences And Engineering
Empresa:

Ivy Exec


Lugar:

Juncos

Detalles de la oferta

The role After completion of the on-boarding and applicable training/qualifications; you will join a team focused on purification downstream processes to support Drug Substance manufacturing operations and subsequently impact patient’s lives every day. Day to day activities will include laboratory bench scale execution and on-the-floor commercial support to the manufacturing facilities. Your primary technical areas of focus will be the laboratory and commercial scale using your expertise with protein chromatographic techniques (ie. Protein A, cation and anion exchange, mixed mode interaction, etc.) and filtration systems (ie. tangential flow filtration) used during the manufacturing of biologically derived therapeutics. This is a phenomenal opportunity to gain a deep insight into development and optimization of processes as well as processes technology transfer activities across different Amgen sites. In this role you will conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general mentorship of supervisor. You will also: 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 The position will be reporting to an administrative work schedule with the flexibility to support the non-standard shift organization, as per business needs. Specific responsibilities include but are not limited to: Apply advanced technical principles, theories, and concepts in the development of new principles and concepts. Establish leads and/or participate in technical forums for sharing of best practices and technical topics related to purification downstream process expertise Support technology transfer projects for drug substance operations. Timely and regular attendance to workplace May introduce advanced scientific methods. 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 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. Be flexible to support extended hour and / or non-standard shifts Keeps current in field of scientific expertise and areas relevant to their function Basic qualifications Doctorate degree 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 in Life Sciences and/or Engineering Advanced laboratory work skills. Experience with drug substance manufacturing, process validation, process monitoring and/or process qualifications. Knowledge of statistical data analysis and design of experiments Working knowledge of pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment. Ability to apply science to production. Able to develop solutions to routine technical problems of limited scope. Familiarity with validation processes Be organized, have multi-task project experience and be able to communicate & work well with other departments Demonstrated skills in problem solving, negotiation, persuasion and facilitation Bilingual English and Spanish with verbal and written communication technical writing skills in both languages Computer literacy (Windows environment: Word, Excel, Power Point)


Fuente: Adzuna_Ppc

Requisitos


Conocimientos:
Scientist - Drug Substance Purification Sciences And Engineering
Empresa:

Ivy Exec


Lugar:

Juncos

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