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Process Specialist, Technical Program Team

Company: LGC Limited
Location: Novato
Posted on: January 13, 2021

Job Description:

Position Summary:The Process Specialist, GMP Technical Program Team, is responsible for providing support to the GMP Planning and Manufacturing process under supervision of the Technical Program Manager. The role performs a variety of duties related to collection, analysis, and interpretation of data to continuously improve processes and establish new parts and processes. This position works in line with the Technical Program Manager in support of product investigations, process development, methods training and documentation.This is a hands on technical role along with exposure to program management and is responsible for supporting key process and quality monitoring of the GMP oligonucleotide manufacturing process. As a member of the Technical Program Team, the role is primarily responsible for the successful transfer of new parts in the GMP Manufacturing line and scale up assessments for existing parts with collaboration with the Manufacturing Operations Specialist, Project Coordinator teams and GMP management teams. This role also provides support to key account program management and manufacturing management in the form of database part number creation, process improvement, data analysis, project management/coordination, on-board program training and support.Areas of Responsibility:To perform this job successfully, an individual must be able to perform each essential function satisfactorily.* Ensure that tasks are completed in a timely manner to support technical personnel in manufacturing and planning* Perform manufacturing department's specialty projects as directed by the technical program manager* Execute activities for process monitoring, data analysis, yield analysis, scale-up analysis and part analysis. Successfully implement new parts and scale up parts in the existing GMP Manufacturing department.* Compute and report data in a concise manner to cross functional stakeholders.* Write/review technical and non-technical documents to support optimization and implementation of new processes.* Create new part numbers in the database, with strong attention to detail making sure that technical data is flowing from the customer to the planning team via customer service in an organized and documented fashion.* Data analysis in projects like continuous improvement, CAPA, CSI and root cause analysis.* Coordinate with Program/Project/Manufacturing managers to meet requirements and generate documentation as directed.* Implement and maintain program for new parts, complex part number and scale up part numbers.* Review of data post production with specialist team and manufacturing management to implement changes to the part or process as needed.* Coordinate and collaborate with cross functional stakeholders and deliver multiple complex projects.* Communicate with management and work cross-functionally across teams to constructively resolve product program issues that impact manufacturing efficiency, quality and on-time delivery objectives* Assist management with administrative support functions and database projects as neededEssential Functions:* Implement Assigned tasks in a timely manner.* Assist with identifying, scoping and delivering multiple projects with collaboration.* Participate in projects that help identify root cause and generate reports as directed by the Technical Program manager.Other Skills, Abilities, and Competencies:* Ability to adapt to rapidly changing priorities and flexibility to support manufacturing operations.* Knowledge of process design and validation is an asset.* Professional presence and strong attention to detail* Data analysis proficiency* Developed professional communication skills; written, presentation, verbal* Self-starter, able to independently find data and analysis solutionsCA2QualificationsEducation/Experience/Licenses/Certifications Bachelor's degree in Biochemistry, Chemistry, Chemical Engineering, related science field or 5+ years of industry experience and/or demonstrated proficiency to meet the Process Specialist, GMP Technical Program.Technology/Equipment Skills:Microsoft Office, Outlook, Word, and Excel, Power BI a plusUse of a web browser.Other Skills, Abilities, and Competencies:* Ability to adapt to rapidly changing priorities and flexibility to support manufacturing operations.* Knowledge of process design and validation is an asset.* Professional presence and strong attention to detail* Data analysis proficiency* Developed professional communication skills; written, presentation, verbal* Self-starter, able to independently find data and analysis solutions

Keywords: LGC Limited, Novato , Process Specialist, Technical Program Team, Other , Novato, California

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