What are the responsibilities and job description for the USA-Scientist III (Scientific) position at Artech LLC?
Job title : Scientist III
Location : Framingham, MA
Duration : 12 months
Job description :
Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement.
Anticipate, respond to, and permanently resolve issues that arise during production.
Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
Lead the creation and use of digital process data analytic systems.
Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
KEY RESPONSIBILITIES :
Provide technical support and routine process monitoring for upstream mammalian manufacturing of commercial products.
Review manufacturing processes, deviations, and / or development and production data.
Review manufacturing batch records, protocols, and control strategies.
Provide technical support and data analysis for investigations and deviation resolution.
Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
Interact with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
Oversee and report on overall manufacturing progress.
Lead technical project team or cross-functional team between groups / organizations. Provide input and coordinate support from process development teams.
Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate / implement changes if required.
Provide CMC support and guidance for product life cycle management.
Provide technical guidance and train less experienced staff.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
BASIC QUALIFICATIONS :
Bachelor s degree in engineering or science with 5 - 7 years of experience
Master s degree in engineering or science with 3 - 5 years of experience
PhD in engineering or science with 0 3 years of experience.
PREFERRED QUALIFICATIONS :
Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.
Experience with biologics mammalian upstream unit operations : vial thaw, seed train, wave reactors, production reactors, harvest and capture column operations. Experience with perfusion cultures is highly preferred.
Hands-on cell culture experience at laboratory or pilot scale.
Understanding of cGMP concept and familiar with quality and regulatory framework.
Proficiency in process data analytics.
Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, DeltaV Process Data Historian, LIMS, and MES.
Experience leading projects and / or cross functional teams.
Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Strong communication and technical writing skills. Experience communicating with business partners and senior management.
Experience with root cause analysis and / or risk assessment
Experience working with statistical analysis software
Experience communicating with cross-functional teams and senior management
Proficient in Client Word, Excel, PowerPoint.
SPECIAL WORKING CONDITIONS
Ability to gown and gain entry to manufacturing areas
