Top 3 Must Have Skill Sets:
Experience with Chromatography instruments and software
Familiarity with GMP regulations
Demonstrated ability to work under minimal direction
**Fully remote/can sit anywhere in the US**
Candidates must have GMP/Chromatography experience in order to be shortlisted.
The Attribute Sciences Data Engineering (ASDE) group provides scientific and technical engineering expertise in support of pipeline and commercial portfolio. This Lab Informatic team within ASDE supports the end to end data flow from instruments to the data lake to provide advanced data and computational analytics to advance products.
This position is part of the Lab Informatics team in the ASDE group and will support Process Development (PD) CDS systems (Empower, Chromeleon and associated upstream and downstream connections to S-Maxtrix Fusion and Biovia Electronic Lab Notebook (ELN). Responsibilities will vary and include supporting software lifecycle upgrades and ad-hoc changes to the CDS systems, authoring for document changes, and collaborating cross-functionally to implement corrections. Another responsibility of this role will be the optimization of processes, and procedures. The position offers the opportunity to engage with staff within PD, R&D, QC across 8 global sites.
• Learn and develop proficiency on CDS systems (Empower, Chromeleon).
• Provide support for AS for CDS systems.
• Collaborate with Operation IS and Scientists for upgrades, changes, and enhancements for the CDS systems.
• Interface with product quality, quality control, quality assurance, and manufacturing organizations to troubleshoot and resolve instrument and method issues
• Support on-going GMP activities such as the generation of the annual product review documents, regulatory inspections, and process documentation
• Interface with analytical scientists, process development scientists, and engineers to assess, understand best practices and solutions for the CDS systems.
• Master’s degree
• Bachelor’s degree and 2 years of scientific or engineering experience
• Associate’s degree and 6 years of scientific or engineering experience
• High school diploma / GED and 8 years of scientific or engineering experience
• Experience with Chromatography instruments
• Experience with Empower, Chromeleon, Fusion, BioVIA One Lab
• Familiarity with GMP regulations
• Ability to deliver high quality results in a timely manner
• Excellent written and verbal communication
• Demonstrated ability to work under minimal direction
• Ability to adapt to changing business needs
• Ability to multi-task and function in a dynamic environment
• Ability to solve difficult, non-routine analysis problems, applying advanced statistical analysis as needed.
Committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
"This posting is for Contingent Worker, not an FTE"