Process Specialist, Technical Program Team
Company: LGC Limited
Location: Novato
Posted on: January 13, 2021
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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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